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Plenary Sessions 1 TREATMENT STRATEGIES IN 2000 Abstracts PL1.1 thru PL1.4, Page S1 |
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| PL1.1 | PLANNING FIRST LINE (AND THEREFORE SECOND LINE) THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL1.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S1 S. Hammer When selecting the specific components of the initial regimen, practical alternatives, depending upon the strategy chosen, should already be in hand and can be assisted by drug resistance testing in the circumstance of a suboptimal response or virologic failure. As new options from both existing and new drug classes emerge, the ability to choose . . . . |
| PL1.2 | TREATMENT FAILURE AND ITS MANAGEMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL1.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S1 D. Sven Not available |
| PL1.3 | ADHERENCE TO MEDICATION: ADHERENCE TO HIGHLY ACTIVE ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL1.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S1 G. Friedland The correlates of adherence to HIV medications have been elucidated in an array of studies and include characteristics of the patient, provider of care, regimen, disease status and clinical setting. Based upon these, many strategies for improving adherence have been proposed including assessing readiness to begin therapy, provision of information, . . . . |
| PL1.4 | TREATMENT INTERRUPTIONS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL1.4 AIDS 2000, Oct 22-26;14(Suppl. 4);S1 B. Hirschel Not available |
| PL1.5 | MOMENTS OF DECISION: PATIENTS’ PERSPECTIVES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL1.5 AIDS 2000, Oct 22-26;14(Suppl. 4);S1 F. Houyez Not available |
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2 MOTHER TO CHILD TRANSMISSIONS AND THERAPEUTIC INITIATIVES IN UNDER RESOURCED COUNTRIES Abstract PL2.1 thru PL2.4, Pages S1 to S2 |
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| PL2.1 | INTERRUPTING MATERNAL-FOETAL TRANSMISSION: STATE-OF-THE-ART REVIEW Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL2.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S1 H. Coovadia A single dose of nevirapine (NVP) to the mother (during delivery) and to the newborn promises to be the simplest and most cost-effective regimen with sustained bene- ficial effect up to one year. Medium term data on the adverse affects of foetal and neonatal exposure to AZT, and short term reports on NVP, are reassuring. Breastfeeding remains the norm . . . . |
| PL2.2 | THERAPEUTIC INITIATIVES IN THAILAND Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL2.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S2 P. Phanuphak There are several other therapeutic initiatives in Thailand. Prevention of mother-to child transmission (PMTCT) is another major activity. Several short-course AZT trials in Thailand have just been concluded. The results of these trials, as well as the Thai Red Cross donation campaign to prevent MTCT drive government’s decision to implement PMTCT nationwide. . . . |
| PL2.3 | ANTIRETROVIRAL THERAPY: UTOPIA AND REALITY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL2.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S2 P. Cahn Not available |
| PL2.4 | WHAT DOES IT TAKE TO PROVIDE ANTIRETROVIRAL THERAPY TO DEVELOPING COUNTRIES? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL2.4 AIDS 2000, Oct 22-26;14(Suppl. 4);S2 J. Lange Not available |
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3 ANTIVIRAL THERAPY IN DIFFERENT POPULATIONS Abstract PL3.1 thru PL3.7, Pages S2 to S4 |
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| PL3.1 | ANTIVIRAL THERAPY IN CHILDREN: REVIEW OF THE ISSUES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL3.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S2 C. Giaquinto Not available |
| PL3.2 | ANTIVIRAL THERAPY IN WOMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL3.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S2 D. Mercey Not available |
| PL3.3 | ANTIVIRAL THERAPY AND MANAGEMENT OF HIV IN INTRAVENOUS DRUG USERS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL3.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S2 F. Mulcahy The management of HIV infection is therefore both complex and challenging. Options include linking ART with daily observed methadone maintenance therapy, choosing simple once or twice daily regimens anticipating and treating drug interactions and consistent patient evaluation at combined addiction/ medical trials. |
| PL3.4 | VIRAL LOAD CHANGES IN RESPONSE TO ANTIRETROVIRAL THERAPY ACCORDING TO THE BASELINE CD4 LYMPHOCYTE COUNT AND VIRAL LOAD Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL3.4 AIDS 2000, Oct 22-26;14(Suppl. 4);S3 A.N. Phillips, S. Staszewski, R.Weber, O. Kirk, P. Francioli, V. Miller, P. Vernazza, J. Lundgren and B. Ledergerber on behalf of the Swiss HIV Cohort Study, the Frankfurt HIV Clinic Cohort and the EuroSIDA Study Group Precise characterization of the relationship between baseline CD4 count/viral load and viral load response would provide information for the decision of when to initiate antiretroviral therapy. We studied 2742 therapy-naïve individuals from three clinic-based cohort studies who initiated antiretroviral therapy in 1996 or after and have been followed for a median . . . . |
| PL3.5 | WHEN TO START HAART IN CHRONICALLY HIV-INFECTED PATIENTS? A COLLECTION OF PIECES OF EVIDENCE FROM THE I.CO.N.A. STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL3.5 AIDS 2000, Oct 22-26;14(Suppl. 4);S3 A. Cozzi Lepri1, A.N. Phillips1, A. d’ Arminio Monforte2, S. Muro2, A. De Luca2, P. Pezzotti2, P. Vigano 2, A. Orani2, S. d’ Elia 2 and M. Moroni2 This non-randomised study could only address some aspects related to the issue of when to start HAART in asymptomatic infection. However, our data show no clear immunological or virological advantage in starting HAART at a CD4 count > 350 rather than starting when CD4 count ranges between 200 and 350. They also confirm that CD4 count rises are clinically meaningful, in that they are associated with reduced risk of AIDS and death. |
| PL3.6 | PLASMA AND TISSUE HIV-1 AND HIV-2 VIRAL LOAD IN HIV-2 AND DUAL HIV-1/HIV-2 INFECTED INDIVIDUALS: IMPLICATIONS FOR STARTING HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL3.6 AIDS 2000, Oct 22-26;14(Suppl. 4);S3 M. Schutten, M.E. van der Ende, K. Tenner-Racz, P. Racz, H.G.M. Niesters and A.D.M.E. Osterhaus On basis of these results and the limited options for treating HIV-2 (inadequate efficacy of NNRTIs and most probably also nelfinavir and amprenavir) we recommend starting ART as late as possible (CD4+ cells < 300/µl or plasma HIV-2 RNA levels > 5000 copies/ml). The fact that both HIV-1 and HIV-2 may actively replicate in dual HIV-1/HIV-2+ individuals also indicate that it is wise to refrain from treating such individuals with antivirals that are not efficacious against HIV-2. |
| PL3.7 | COMPLIANCE IS SIGNIFICANTLY BETTER IN HAART RESPONDERS COMPARED TO NON-RESPONDERS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL3.7 AIDS 2000, Oct 22-26;14(Suppl. 4);S3 A.-M. Vandamme1, K. Van Vaerenbergh1, A. Deschamps1, V. De Graeve1, V. De Saar1, B. Maes1, H. Ceunen1, K. De Smet2, W. Peetermans1, H. Bobbaers1, M. Van Ranst1, J. Desmyter1, E. De Clercq1, E. Van Wijngaerden1 and S. De Geest1 Perfectly compliant patients can control virus replication for a prolonged period, even in the presence of baseline resistance mutations. The patients that had a poor response to HAART were also those with a signifi- cantly lower compliance. In our patient population, reduced compliance resulted in therapy failure, mostly associated with a build-up of resistance mutations. |
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4 RESISTANCE Abstract PL4.1 thru PL4.5, Pages S4 to S4 |
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| PL4.1 | OVERVIEW ON THE LATEST ON GENOTYPE/PHENOTYPE AND REPLICATIVE FITNESS: THE SCIENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL4.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S4 D.D. Richman Data to partially address each of these questions have been generated. Defining what is not adequately answered will help direct more effective clinical research. |
| PL4.2 | THE VALUE AND LIMITATIONS OF RESISTANCE TESTING AND HOW BEST TO USE IT: PRACTICALITIES FOR THE PHYSICIAN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL4.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S4 V. Miller Not available |
| PL4.3 | THE TRANSMISSION OF RESISTANT VIRUSES AND IMPLICATIONS FOR THERAPY AND OUTCOME Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL4.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S4 L. Perrin Not available |
| PL4.4 | PERSISTENCE OF HIV-1 REPLICATION AND GENOTYPIC RESISTANCE IN SANCTUARY SITES AFTER 3 YEARS OF EFFECTIVE HAART: RELEVANCE OF PROTEASE INHIBITORS DIFFUSION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL4.4 AIDS 2000, Oct 22-26;14(Suppl. 4);S4 A. Lafeuillade1, C. Solas2, G. Hittinger1, S. Chadapaud1, H. Khiri3, P. Halfon3, B. Lacarelle2 A large inter-individual variability of IDV and NFV concentrations was found in the different sanctuary sites. Residual viral replication and resistance appear to be related with PIs diffusion in semen but not in CSF and lymph nodes. |
| PL4.5 | R165335–TMC125, A NOVEL NON NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI) WITH NANOMOLAR ACTIVITY AGAINST NNRTI RESISTANT HIV STRAINS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL4.5 AIDS 2000, Oct 22-26;14(Suppl. 4);S4 K. Andries1, M.-P. de Béthune2, D.W. Ludovici3, M.J. Kukla3, H. Azijn2, P. Lewi4, P.A.J. Janssen4 and R. Pauwels2 Evaluation of > 300 triazine and pyrimidine analogues of a lead molecule led to the identification of a series of compounds active in the nanomolar range against both wt and resistant strains. R165335–TMC125, a diaminopyrimidine (DAPY) derivative, had the best antiviral potency profile. . . . |
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5 INFECTIONS AND TUMOURS Abstract PL5.1 thru PL5.6, Pages S5 to S6 |
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| PL5.1 | OPPORTUNISTIC INFECTIONS: WHAT’S NEW? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL5.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S5 H. Furrer New recommendations on prophylaxis and maintenance therapy: Taking into account the decreased risk of OIs in patients on ART, new recommendations about discontinuation of prophylaxis and maintenance therapy seem warranted. Numerous studies addressing the safety of discontinuation are being performed. . . . |
| PL5.2 | HIV AND HEPATITIS – HBV AND HCV Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL5.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S5 A. Hatzakis Not available |
| PL5.3 | KAPOSI’S SARCOMA HERPESVIRUS: FROM CELL BIOLOGY TO PATHOGENESIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL5.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S5 C. Boshoff Kaposi’s sarcoma lesions can resolve with partial restoration of the immune system, i.e. post-transplantation KS resolves when immunosuppression is stopped and AIDS-KS often improves with HAART. This suggests that cytotoxic T cell (CTL) responses against KSHV might be important in the pathogenesis of KS. The identification of CTLs against this virus will be discussed. |
| PL5.4.1 | EFFICACY OF THE REGENERATING IMMUNE SYSTEM IN THE INHIBITION OF CMV REPLICATION AFTER HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL5.4.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S5 J.R. Deayton, C.A. Sabin, M.A. Johnson, P.D. Griffiths, V.C. Emery The calculated mean antiviral efficacy of the regenerating immune system of 61.5% may be compared to that of ganciclovir which has a mean efficacy of 91.5% against wild type CMV. This further explains the protective effect of HAART against CMV disease, even in patients with high CMV loads at baseline. The half-life of decline of CMV DNA in blood after HAART is variable. . . . |
| PL5.4.2 | RECURRENCE OF CMV VIRAEMIA AND DEVELOPMENT OF ANTI-CMV DRUG RESISTANCE IN PATIENTS RECEIVING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY AFTER CMV RETINITIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL5.4.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S5 J.R. Deayton, C. Shannon-Lowe, P. Wilson, M.A. Johnson, P.D. Griffiths, V.C. Emery Patients who have received HAART and have extended survival rates following CMV retinitis (CMVR) have now had prolonged exposure to anti-CMV therapies. This study aims to identify risk factors for recurrence of CMV viraemia in such patients and to investigate the development of ganciclovir resistance associated with the long term receipt of maintenance therapy for CMVR. |
| PL5.5 | THE CORRELATION BETWEEN THE DEVELOPMENT OF CYTOMEGALOVIRUS RETINITIS AND THE CYTOMEGALOVIRUS-SPECIFIC IMMUNOLOGIC REACTIVITY OF T-CELLS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL5.5 AIDS 2000, Oct 22-26;14(Suppl. 4);S6 Sung-Chin Pan, Szu-Min Hsieh, Chien-Ching Hung, Hsing-Chun Tsai, Mao-Yuan Chen and Shan-Chwen Chang Thus, the development of CR may be associated with poor reactivity of CD4+ T-cells, but not with that of CD8+ T-cells, against CMV. Post-HAART CR may be due to poorly reconstituted immune response to CMV, rather than immune rebound. This evaluation of CMV-specific immune reactivity may help select high-risk patients who may benefit from pre-emptive CMV therapy. |
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6 NOVEL ASPECTS OF INFECTION AND TREATMENT Abstract PL6.1 thru PL6.6, Pages S6 to S8 |
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| PL6.1 | POST-EXPOSURE PROPHYLAXIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S6 D. Henderson Not available |
| PL6.2 | INFECTIVITY AND SEXUAL TRANSMISSION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S6 P.L. Vernazza Antiretroviral therapy significantly reduces the genital shedding of HIV, i.e. the viral inoculum. There is limited information about this effect of therapy on HIV incidence but intuitively, any reduction of the inoculum size must result in lower risk of transmission, as has been demonstrated for the case of vertical transmission. . . . |
| PL6.3 | TENOFOVIR DISOPROXIL FUMARATE (TDF) FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED PATIENTS: A 48 WEEK ANALYSIS OF A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S6 R. Schooley1, P. Ruane2, R. Myers3, G. Beall4, H. Lampiris5, D. Berger6, M. Miller7, A. Cheng7, R. Mills7 and I. McGowan7 for the Study 902 Team Tenofovir DF is a once daily nucleotide analogue reverse transcriptase (RT) inhibitor with potent activity against wild type and nucleoside resistant HIV. Patients with HIV RNA between 400 and 100 000 copies/ml were randomized 2 : 2 : 2 : 1 in a blinded fashion to receive 75 150 or 300 mg of TDF or placebo in addition to their stable antiretroviral therapy (ART) at 22 sites. . . . |
| PL6.4 | A NOVEL USE OF ABACAVIR TO SIMPLIFY THERAPY AND REDUCE LONG-TERM TOXICITY IN PI-EXPERIENCED PATIENTS SUCCESSFULLY TREATED WITH HAART: 48-WEEK RESULTS (CNA30017) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.4 AIDS 2000, Oct 22-26;14(Suppl. 4);S7 M. Youle for the CNA30017 study team These data demonstrate sustained virological suppression following a switch from PI-containing HAART to simplified, ABC-based triple nucleoside therapy, with a trend to lower triglyceride and cholesterol and increased treatment satisfaction. Viral rebound following switch to ABC was associated with single mutations only, which would allow many salvage options. |
| PL6.5 | ABT-378/RITONAVIR (ABT-378/r) VERSUS NELFINAVIR IN ANTIRETROVIRAL NAÏVE SUBJECTS: WEEK 48 COMPARISON IN A PHASE III BLINDED RANDOMIZED CLINICAL TRIAL Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.5 AIDS 2000, Oct 22-26;14(Suppl. 4);S7 M. Johnson1, G. Beall2, A. Badley3, W. Cameron3, D. Johnson4, P. Ruane5, R. Rubio6, R. Stryker7, S. Walmsley8, M. King9, P. Cernohous9, J. Moseley9, M. Opferman9, M. Sattler9, B. Bernstein9, and E. Sun9 for the M98–863 Study Team A significantly greater proportion of ABT-378/r treated subjects achieved HIV RNA below the LOQ in all analyses at Weeks 40 and 48. Both regimens were well tolerated, as manifested by the low incidence of study drug-related discontinuations through week 40. |
| PL6.6 | BMS-232632 - CLINICAL TRIAL AI424–007: SAFETY, EFFICACY OF A ONCE DAILY PROTEASE INHIBITOR AT 24 WEEKS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.6 AIDS 2000, Oct 22-26;14(Suppl. 4);S7 P.J. Piliero1, I.M. Sanne2, R. Wood3, T. Kellher4, A. Mongillo4, A. Cross4, S. Schnittman 4 and M. Giordano4 In conclusion, results at the 24-week (stage I) evaluation in trial AI424– 007 support this potent PI as a component of combination therapy due to its efficacy, safety and tolerability, and once daily dosing. |
| PL6.7 | CONTINUED INDINAVIR (800 MG TID) VERSUS SWITCHING TO INDINAVIR + RITONAVIR (800/100 MG BID) IN HIV PATIENTS HAVING ACHIEVED VIRAL LOAD SUPPRESSION. A RANDOMIZED STUDY: THE BID EFFICACY AND SAFETY TRIAL (BEST) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.7 AIDS 2000, Oct 22-26;14(Suppl. 4);S8 D. Podzamczer1, J. Arrizabalaga2, P. Van Wanzeele3, M. Harris4, C. Pedersen5, P. Cahn6, A. Casiro7, F. Chiodo8, J.A. Arnaiz9 and J.M. Gatell9 for the BEST Study Team These preliminary data suggest that bid administration of IDV 800 mg in combination with RTV 100 mg is generally well tolerated and maintains comparable viral suppression in stable HIV-infected patients in comparison with the standard tid regimen. |
| PL6.8 | A RANDOMISED TRIAL EVALUATING THREE NRTI REGIMENS WITH AND WITHOUT NELFINAVIR IN HIV-INFECTED CHILDREN: 48-WEEK FOLLOW-UP FROM THE PENTA 5 TRIAL Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.8 AIDS 2000, Oct 22-26;14(Suppl. 4);S8 D.M. Gibb for the PENTA 5 Executive and the PENTA Steering Committees The ABC-containing arms were well generally tolerated and resulted in the greatest reduction in VL. There were no serious concerns about NFV toxicity. |
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7 HARNESSING THE IMMUNE RESPONSE Abstract PL7.1 thru PL7.6, Pages S8 to S9 |
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| PL7.1 | WHAT ARE THE DIFFERENCES IN IMMUNE RESTORATION IN RESPONSE TO HAART AT DIFFERENT LEVELS OF IMMUNE SUPPRESSION/IMMUNODEFICIENCY AT INITIATION OF TREATMENT AND DO THEY MATTER? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL7.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S8 C. Lane Not available |
| PL7.2 | IMMUNE BASED THERAPY AND THERAPEUTIC VACCINES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL7.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S9 G. Pantaleo Not available |
| PL7.3 | INDUCTION OF PROTECTIVE IMMUNITY AGAINST HIV/AIDS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL7.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S9 M. Girard . . . .the first phase III efficacy trials with a bivalent gp120 subunit vaccine have been initiated last year in the USA with clade B antigens and in Thailand with a mixture of clade B and clade E antigens. In spite of such progress, the development of a simple vaccine capable of inducing cross-neutralizing antibodies against primary virus isolates and broad polyepitopic CD8+ T-cell responses in a majority of vaccinees still remains an elusive challenge. |
| PL7.4 | FUNCTIONAL SIGNIFICANCE OF CD4 CELL NUMBERS ON THE WAY DOWN VERSUS ON THE WAY UP Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL7.4 AIDS 2000, Oct 22-26;14(Suppl. 4);S9 M.M. Lederman, H. Valdez, K. Medvik, D. Dorazio, R. Asaad, C. Pacheko and J. Sierra-Vladero CD4 cell numbers do not necessarily reflect the repertoire of CD4 cell recognition in treated and untreated HIV infection. While selected responses are well restored after suppression of HIV replication, others are not and this may reflect exposure to antigen and targeted effects of HIV replication on cell function. |
| PL7.5 | A RANDOMIZED CONTROLLED PHASE II STUDY OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) WITH INTERMITTENT INTERLEUKIN-2 (IL-2) BY CONTINUOUS IV (CIV) OR SUBCUTANEOUS (SC) ROUTES IN HIV-INFECTED PATIENTS WITH CD4+ COUNTS 50–350 CELLS/MM³: ACTG 328-RESULTS AT 60 WEEKS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL7.5 AIDS 2000, Oct 22-26;14(Suppl. 4);S9 R. Mitsuyasu, R. Pollard, R. Gelman, D.Weng for the ACTG 328 protocol team Significant increases in CD4+ counts were seen with both CIV and SC IL-2 compared to HAART alone after 60 weeks of therapy. IL-2 did not appear to increase or decrease the proportion of patients with plasma RNA < 50 copies/ml after 60 weeks of initial HAART therapy. An early trend to somewhat lower occurrence of AIDS-defining illnesses was observed in IL-2 treated patients, although the study was not designed to detect this difference. Additional clinical and immunologic and virologic follow-up of these patients is in progress. |
| PL7.6 | CONTINUED LOW MORBIDITY AND MORTALITY AMONG PATIENTS WITH ADVANCED HIV INFECTION AND THEIR PATTERNS OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) USAGE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL7.6 AIDS 2000, Oct 22-26;14(Suppl. 4);S9 F. Palella Not available |
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8 PHARMACOLOGY AND THERAPEUTIC DRUG MONITORING Abstract PL8.1 thru PL8.7, Pages S10 to S11 |
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| PL8.1 | KEY PHARMACOLOGICAL ISSUES IN HIV THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL8.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S10 D. Back Finally if we are to understand the complex mechanisms of mitochondrial toxicity or drug hypersensitivity which have emerged as concerns for HIV therapy then basic and clinical pharmacology must be part of the armamentarium to tackle these and related issues. |
| PL8.2 | THERAPEUTIC DRUG MONITORING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL8.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S10 D.M. Burger Based on the above arguments, TDM, especially for the protease inhibitors, appears indicated. Some argue that controlled clinical trials need to demonstrate a clinical benefit of TDM before it can be recommended as standard care, while others already use it in their routine patient management. Pros and cons of TDM will be discussed. |
| PL8.3 | DRUG INTERACTIONS - WHICH ONES ARE CLINICALLY IMPORTANT? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL8.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S10 R. Hoetelmans Not available |
| PL8.4 | MEASUREMENT OF NUCLEOSIDE ANALOGUE TRIPHOSPHATES BY ENZYMATIC ASSAY IN HIV PATIENTS IN A CLINICAL SETTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL8.4 AIDS 2000, Oct 22-26;14(Suppl. 4);S10 P.G. Hoggard1, S. Kewn1, S.D. Sales1, J. Lloyd1, B. Maher1, S.H. Khoo1, E.Wilkins2, T. Jones3, D. Pillay4, C. Sabin5 and D.J. Back1 These data illustrate the importance of determining drug triphosphate/ dNTP ratios in HIV-positive patients. |
| PL8.5 | NEVIRAPINE-INDUCED LIVER TOXICITY: A PROSPECTIVE COHORT STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL8.5 AIDS 2000, Oct 22-26;14(Suppl. 4);S11 E. Martínez1, J.A. Arnaiz2, A. Cruceta1, J.B. Pérez-Cuevas1, A. Mocroft3, X. Carné2 and J.M. Gatell1 NVP was generally well tolerated. Clinical hepatitis seldom appeared and other underlying factors might be related. Abnormalities in ALAT or ASAT increased steadily along first year of therapy, but they were mainly asymptomatic. LFT monitoring during first 1–2 months of therapy does not seem to be justified. |
| PL8.6 | HEPATIC SAFETY WITH NEVIRAPINE (NVP) AND TWO NUCLEOSIDES IN PATIENTS WITH ADVANCED HIV INFECTION, FROM A PLACEBO (PBO) CONTROLLED CLINICAL ENDPOINT TRIAL (1090) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL8.6 AIDS 2000, Oct 22-26;14(Suppl. 4);S11 P. Cahn1, M. Johnson2, R. Nusrat3, D. Hall3, P. Robinson3 and the 31090 Study Team Hepatic events are encountered in HIV-infected patients taking NVP and non-NVP containing regimens. Understanding potential risk factors and clinically appropriate caution should help to minimize important HEs in patients receiving combination antiretroviral therapy. |
| PL8.7 | REDUCED BONE MINERAL DENSITY IN HIV POSITIVE INDIVIDUALS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL8.7 AIDS 2000, Oct 22-26;14(Suppl. 4);S11 A.L. Moore, A, Vashist1, A. Mocroft, A.N. Phillips, J. Studd1 and M.A. Johnson The prevalence of reduced bone density in this HIV positive population is high and our results suggest evidence of an association with use of antiretroviral treatment. Further analysis, particularly of different treatment regimens, on a larger sample is ongoing. |
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9 LATE BREAKERS Abstract PL9.1 thru PL9.7, Pages S12 to S13 |
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| PL9.1 | ACTIVITY OF CYCLOSPORIN A IN COMBINATION WITH HIGHLY ACTIVE ANTIRETROVIRAL THERAPY IN PRIMARY HIV-1 INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL9.1 AIDS 2000, Oct 22-26;14(Suppl. 4);S12 G.P. Rizzardi1, B. Capiluppi2, J.P. Chave3, G. Tambussi2, P. Champagne1, A. Harrari1, P.A. Bart1, A. Lazzarin2 and G. Pantaleo1 Not available |
| PL9.2 | PREVENTION OF NEVIRAPINE-ASSOCIATED EXANTHEMA USING SLOW DOSE ESCALATION, ANTIHISTAMINICS OR CORTICOSTEROIDS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL9.2 AIDS 2000, Oct 22-26;14(Suppl. 4);S12 P. Barreiro, V. Soriano, E. Casas2, M. Tellez1, V. Estrada1, R. Hoetelmans3, I. Jiménez-Nácher4 and J. González-Lahoz In conclusion, the incidence of rash complicating the first few weeks of treatment with NVP can be diminished adding corticosteroids or antihistaminics for two weeks to the standard recommendation, or using a slow escalating dosing. This third approach is proven to be pharmacokinetically safe. |
| PL9.3 | SEVERE LIVER TOXICITY IN PATIENTS RECEIVING TWO NUCLEOSIDE ANALOGUES AND A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL9.3 AIDS 2000, Oct 22-26;14(Suppl. 4);S12 I. Sanne on behalf of the FTC-302 Study Investigators and the FTC-302 Independent Clinical Steering Committee In this study, a high incidence of severe liver toxicity was observed, especially in women. Clinically these events were attributed to NVP in combination with d4T and blinded treatment medication. Consistent with recent recommendations, liver enzymes in patients receiving NVP with other antiretrovirals should be monitored closely, particularly during the first 8 weeks of use. |
| PL9.4 | THE CTROUGH INHIBITORY QUOTIENT PREDICTS VIROLOGIC RESPONSE TO ABT-378/RITONAVIR (ABT-378/R) THERAPY IN TREATMENT-EXPERIENCED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL9.4 AIDS 2000, Oct 22-26;14(Suppl. 4);S12 A. Hsu, G.R. Granneman, D.J. Kempf, J. Isaacson, M. King, S. Brun, B. Bernstein and E. Sun This analysis demonstrates that IQ:Ctrough, which accounts for drug exposure as well as viral susceptibility, can be used to estimate antiviral activity in patients with reduced susceptibility. In contrast, PK parameters alone appear to be inadequate for assessing antiviral activity of PIs in vivo, particularly in previously treated patients. |
| PL9.5 | USE OF NEURAL NETWORKS TO DEFINE THE GENETIC BASIS OF HIV-1 RESISTANCE TO D4T Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL9.5 AIDS 2000, Oct 22-26;14(Suppl. 4);S12 B.A. Larder and D.Wang In conclusion, these results show that at least 26 RT mutations may play a role in d4T resistance, including AZT resistance mutations. Refinement of these models should further enhance our understanding of the genetic basis of d4T phenotypic resistance. |
| PL9.6 | TRANSMISSION AND FITNESS OF DRUG RESISTANT STRAINS OF HIV Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL9.6 AIDS 2000, Oct 22-26;14(Suppl. 4);S13 A.J. Leigh Brown, S.D.W. Frost, J.M. Whitcomb, A.R. McLean, N.S. Hellmann, C.S. Leen, R.P. Brettle, D.V. Havlir, W.C. Mathews, D.D. Richman and S.J. Little Genotypic data from 111 individuals with primary HIV infection who had not received antiretroviral therapy revealed nine bearing mutations at primary resistance-associated amino acids in RT. The probable frequency of transmission of drug resistant strains in this group is therefore 9/111 = 8%. Defining ‘potential transmitters’ as individuals with plasma viral load (pVL) > 1500 copies/ml yields an estimate of 33% for the proportion of potential transmitters . . . . |
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10 ADVERSE EVENTS OF THERAPY Abstract PL10.1 thru PL10.7, Pages S13 to S14 |
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| PL10-1 | A PERSPECTIVE ON THE ADVERSE EVENTS OF HAART: AN OVERVIEW TO INCLUDE LIPODYSTROPHY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL10-1 AIDS 2000, Oct 22-26;14(Suppl. 4);S13 D. Cooper Not available |
| PL10-2 | PATHOGENESIS OF LIPODYSTROPHY AND METABOLIC DISORDERS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL10-2 AIDS 2000, Oct 22-26;14(Suppl. 4);S13 M. Schambelan Not available |
| PL10-3 | LIPODYSTROPHY SYNDROME: DEVELOPING A CASE DEFINITION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL10-3 AIDS 2000, Oct 22-26;14(Suppl. 4);S13 A. Carr Under the auspices of the EMEA, an industry-sponsored study has begun in 37 sites worldwide that will endeavour to generate a valid, simple and broadly applicable case definition. The case-control approach developed by the American Rheumatology Association over the last 30 years for the diagnosis of a large number of rheumatic diseases has been adopted and will be discussed, along with the study outline. |
| PL10-4 | MANAGEMENT OF LIPODYSTROPHY AND METABOLIC DISORDERS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL10-4 AIDS 2000, Oct 22-26;14(Suppl. 4);S13 F. Goebel In a variety of uncontrolled or randomised switch studies substituting PIs or d4T with NNRTIs or other NRTIs most resulted in improvement of lipids, insulin sensitivity and reduction of visceral fat. Reconstitution of subcutaneous fat tissue was rarely observed within 6–12 months. Recent reports on altered cytokine pattern (e.g. TNFα) might justify cytokine changing treatment studies. |
| PL10-5 | THE PHYSICAL AND PSYCHOLOGICAL MANAGEMENT OF LIPODYSTROPHY AND METABOLIC ABNORMALITIES: A PATIENT’S PERSPECTIVE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL10-5 AIDS 2000, Oct 22-26;14(Suppl. 4);S14 Dawn Averitt This presentation will address the complex issues, both physical and psychological, associated with the fat maldistribution and dismorphia (commonly referred to as lipodystrophy) from the perspective of a woman living with AIDS. In addition, the presenter will share several case studies to illustrate the deleterious effect of these abnormalities on quality of life, adherence, and treatment initiation. |
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CONCURRENT SYMPOSIA CS3 NEW THERAPEUTIC OPTIONS IN A NEW CENTURY Abstracts CS3.1 thru CS3.6, Page S15 TO S16 |
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| CS3.1 | OVERVIEW OF PROTEASE INHIBITOR SUBSTITUTION STUDIES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. CS3-1 AIDS 2000, Oct 22-26;14(Suppl. 4);S15 R. L. Murphy Patients on highly active antiretroviral therapy have many treatment options. When protease inhibitor toxicities are suspected, a switch to an alternative regimen consisting of a non-nucleoside plus two nucleosides or of triple nucleosides can be considered effective but is not without modest risk. |
| CS3-2 | PRELIMINARY RESULTS OF A RANDOMISED, OPEN, MULTICENTRE TRIAL COMPARING COMBIVIR PLUS NELFINAVIR OR NEVIRAPINE IN HIV-INFECTED NAÏVE PATIENTS (THE COMBINE STUDY) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. CS3-2 AIDS 2000, Oct 22-26;14(Suppl. 4);S15 D. Podzamczer on behalf of the Combine Study Team No differences in the reduction of VL in samples of lymphoid tissue, CSF and semen were observed between both regimens in a subgroup of patients. In conclusion, these preliminary results suggested that CNr may have greater efficacy than CNf. Both regimens have an acceptable tolerance profile. |
| CS3-3 | EMERGING ISSUES IN NNRTI THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. CS3-3 AIDS 2000, Oct 22-26;14(Suppl. 4);S15 J. Montaner Data from a clinical endpoint study involving approximately 2000 patients with advanced HIV disease have demonstrated the efficacy of nevirapine/ZDV/3TC in patients with high plasma viral loads. They have also provided valuable insights into the safety profile of nevirapine which will be discussed. NNRTI-based regimens provide a valuable treatment option at all stages of HIV disease, provided that they are used in an optimal manner. |
| CS3-4 | PERSPECTIVES ON THE SAFETY PROFILES OF ANTIRETROVIRAL DRUGS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. CS4-4 AIDS 2000, Oct 22-26;14(Suppl. 4);S16 J.M.A. Lange Acute NNRTI toxicity, such as rash, presents during the first weeks of therapy. Vigilance during this predictable period and adherence to empirically formulated rash-management guidelines prevent deterioration to more severe syndromes. Management of chronic toxicity associated with PIs and nRTIs is hampered by their lack of predictability and lack of prophylactic and therapeutic measures (except for nRTI withdrawal in the case of mitochondrial toxicity). . . . |
| CS3-5 | HIVNET 012 - FINAL RESULTS AND IMPLEMENTATION PROGRAMME Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. CS3-5 AIDS 2000, Oct 22-26;14(Suppl. 4);S16 M. Owor Study results indicate that a single dose of NVP given to HIV+ women in labour and to the newborn within 72h of birth is safe and significantly reduces mother-to-child HIV transmission compared with a short course AZT regimen. This reduction is sustained to 12 months in a breastfeeding population. |
| CS3-6 | TIPRANAVIR – THE PROTEASE INHIBITOR FOR THE 21ST CENTURY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. CS3-6 AIDS 2000, Oct 22-26;14(Suppl. 4);S16 R. Wood Tipranavir is a novel protease inhibitor with in vitro activity against resistant HIV-1 isolates. When combined with low dose ritonavir, it is well tolerated and results in plasma tipranavir trough levels well above the corrected IC90 for HIV inhibition. |
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POSTERS 1.1 NEW ANTIRETROVIRALS Abstracts P1 thru P14, Page S17 TO S21 |
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| P1 | EFFICIENCY OF MYELOPEPTIDES (MYELOPID) ADMINISTERING TO HIV PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P1 AIDS 2000, Oct 22-26;14(Suppl. 4);S17 E.T. Taleb, L.P. Siziakina, A.A. Mikhailova, I.L. Docucina Not available |
| P2 | R165335–TMC125, A THIRD GENERATION NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI), INHIBITS 97% OF MORE THAN 1000 RECOMBINANT NNRTI RESISTANT HIV CLINICAL ISOLATES WITH AN IC50 BELOW 100 NM Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P2 AIDS 2000, Oct 22-26;14(Suppl. 4);S17 M.-P. de Béthune1, K. Hertogs2, H. Azijn1, B. Larder3, K. Andries4, P.A.J. Janssen5 and R. Pauwels1 Because of its potency against a vast majority of recent NNRTI resistant HIV clinical isolates, R165335–TMC125 belongs to the third generation of NNRTIs. Its superior in vitro resistance profile makes R165335–TMC125 an excellent candidate for further clinical development. |
| P3 | THE FIRST EXPERIENCE OF HAART WITH PHOSPHAZID + DIDANOSINE + NEVIRAPIN IN HIV-INFECTED PATIENTS IN RUSSIA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P3 AIDS 2000, Oct 22-26;14(Suppl. 4);S17 A.V. Kravtchenko, G.G. Salamov, L.V. Serebrovskaya, E.V. Bogoslovskaya, O.G. Sergienko and V.V. Pokrovsky Preliminary results: after 12 weeks of therapy with PhAZT+ddI+NVP viral load decreased on l.6 Log10. 64% patients had RNA HIV lower than 400 eqc/ml. The count of CD4 cells and CD4/8 ratio significantly increased. The treatment was well-tolerated. We observed only one case of allergic rash associated with nevirapin (after 1 month of therapy) due to that treatment was stopped. We registered decreasing the count of RBC in 1/3 patients. Mean level of ALT changed not significantly. Now the study is still ongoing. |
| P4 | AN INITIAL SAFETY AND EFFICACY CLINICAL TRIAL OF GPG–NH2, A TRIPEPTIDE WITH A NEW ANTIRETROVIRAL MODE OF ACTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P4 AIDS 2000, Oct 22-26;14(Suppl. 4);S17 P.O. Pehrson1,2, A. Sönnerborg 1,2, A. Vahlne3 and J. Spira3 GPN–NH2 has a completely new mode of antiviral activity and hence represents an additional drug alternative to existing therapies, especially for patients with incomplete antiviral response. Further studies will be performed to evaluate the clinical utility of GPG–NH2. |
| P5 | ANTI-HIV ACTIVITY OF DAPD MONOTHERAPY IN TREATMENT-NAÏVE AND TREATMENT-EXPERIENCED SUBJECTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P5 AIDS 2000, Oct 22-26;14(Suppl. 4);S18 F. Raffi1 , H. Kessler, M. Thompson, J. Eron, J. Jacobson, R. Arduino, F. Torriani, S. Deeks, D. Sereni, N. Sista, J. Harris, R. DeMasi, J. Bigley and F. Rousseau These results suggest a dose-dependent clinical antiviral activity of DAPD in treatment-naïve patients, encouraging activity in heavily pretreated subjects, good short-term tolerability profile, and the absence of resistance mutations in a 15-day monotherapy study. These data warrant further clinical development of this novel molecule. |
| P6 | SAFETY, TOLERABILITY AND ANTIVIRAL PHARMACODYNAMICS OF PEGYLATED INTERFERON-α2B IN HIV-1 INFECTION: A PHASE I STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P6 AIDS 2000, Oct 22-26;14(Suppl. 4);S18 A. Hatzakis1, M. Laughlin2, P. Gargalianos3, M. Lazanas4, C. Botsi5, G. Saroglou6 and P. Glue2 In conclusion, PEG-intron up to the dose of 3.0 μg/kg is well tolerated as 4-week monotherapy with a significant inhibitory effect against HIV-1 in vivo. |
| P7 | HIV-1 DYNAMICS IN VIVO AFTER ADMINISTRATION OF PEGYLATED INTERFERON-α-2B (PEG-INTRON) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P7 AIDS 2000, Oct 22-26;14(Suppl. 4);S18 V. Sypsa1, M. Laughlin2, P. Gargalianos3, M. Lazanas4, C. Botsi5, G. Saroglou6, C. Anastassopoulou1, H. Sabatakou3, N. Magafas4, N. Stavrianeas5, P. Giannakopoulou6, P. Glue2 and A. Hatzakis1 In conclusion, antiviral efficacy was associated with baseline immunological parameters and with PEG-intron dose at the lower doses with a plateau effect above 1.5 μg/kg. |
| P8 | IMMUNOLOGIC PROFILE OF HIV-1 INFECTED PATIENTS AFTER ADMINISTRATION OF PEGYLATED INTERFERON-α-2b (PEG-INTRON) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P8 AIDS 2000, Oct 22-26;14(Suppl. 4);S19 V. Vigklis1,3, M. Laughlin2, P. Gargalianos3, M. Lazanas4, C. Botsi5, G. Saroglou6, H. Sabatakou3, D. Paraskeva4, N. Stavrianeas5, N. Mavroidi6, P. Glue2 and A. Hatzakis1 The increasing pattern of CD4 and the decline of CD8 and immune activation markers is consistent with data obtained from PI’s monotherapy and HAART. However, the early increase of naïve CD4 seen in this study is in sharp contrast with HAART where naïve CD4 elevation is a late event. More studies are needed to assess whether this finding is a redistribution phenomenon or an early sign of immune reconstitution. |
| P9 | A PRELIMINARY PHARMACOKINETIC AND PHARMACODYNAMIC EVALUATION OF THE HIV PROTEASE INHIBITOR BMS-232632 IN A PROTEASE INHIBITOR-NAÏVE HIV+ POPULATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P9 AIDS 2000, Oct 22-26;14(Suppl. 4);S19 E. O’Mara1, P. Piliero2, G. Drusano2, V. Mummaneni1, R. Raymond1, S. Preston2, A. Schuster1 and D. Randall1 Analysis of variance was used to evaluate the change from baseline (day 1) to mono-(day 15) then combination therapy (day 29) in HIV RNA. Linear regression analysis was used to assess the relationship between BMS Cmin values and changes in HIV RNA by day 15 and day 29. Least square means calculated for ΔHIV RNA between baseline and day 15 and day 29 were 1.342 and 1.85 log copies respectively. . . . |
| P10 | THERAPY-DRIVEN VIRAL EVOLUTION IN MULTIDRUG-EXPERIENCED HIV-1-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P10 AIDS 2000, Oct 22-26;14(Suppl. 4);S19 S. La Seta Catamancio, E. Bulgheroni, P. Citterio, F. Croce, M. Lo Cicero, M. Galli and S. Rusconi At the end we detected additional mutations: K103K/N and Y181C with the disappearance of mutations at the positions 41 and 184, in the RT gene, while the mutations 164I/V, V82V/I and L90M appeared in the protease. We evidenced a viral evolution in two heavily drug-experienced patients with a stable high viral load. The genotypic and phenotypic pattern of their resistant virus mirrored with the therapeutic regimen used over time. Growth competition experiments are planned in order to assess the extent of relative viral fitness in the presence/absence of different enzyme inhibitor. |
| P11 | THE USE OF MYCOPHENOLIC ACID, AN INOSINE MONOPHOSPHATE DEHYDROGENASE INHIBITOR, AS PART OF SALVAGE THERAPY IN LATE STAGE HIV DISEASE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P11 AIDS 2000, Oct 22-26;14(Suppl. 4);S20 C.M. Toukas and G.E. Hatzakis This small cohort of individuals with advanced HIV disease tolerated MA as part of salvage therapy. At 24 weeks a reduction in viral load, decrease in T cell activation and an increase in CD4 cell count was noted although not significant. Clinical trials of IMPDH inhibitors in HIV disease are thus warranted. |
| P12 | VIROLOGICAL EVALUATION OF THE EFFICACY OF THREE COMPLEMENTARY THERAPIES IN HIV-1 INFECTED INDIVIDUALS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P12 AIDS 2000, Oct 22-26;14(Suppl. 4);S20 Louise C. Dann1, Clive Loveday1 and Bob Jacobs2 No group showed a significant decline in plasma viral load (> 0.5 log copies/ml) during therapy, or a CD4 cell increase. All therapies appear to be well tolerated. Positive responses to complementary therapy were not apparent in any of the studies in individuals not taking any other form of antiretroviral therapy. We continue to monitor new complementary therapies for virological and immunological benefits. |
| P13 | TREATMENT OF THE PATIENTS WITH INTOLERANCE TO AZT BY PHOSPHAZID Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P13 AIDS 2000, Oct 22-26;14(Suppl. 4);S20 O. Yurin, A. Kravtchenko, L. Afonina, N. Buruva, E. Voronin and V. Pokrovsky The replacement of AZT with PhAZT for patients with intolerance for AZT allows them to continue the antiretroviral therapy with success. |
| P14 | TIPRANAVIR (PNU-140690) RETAINS A POTENT ANTIVIRAL IN VITRO ACTIVITY AGAINST HIV-1 ISOLATES DERIVED FROM PI-NAÏVE OR PI-EXPERIENCED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P14 AIDS 2000, Oct 22-26;14(Suppl. 4);S20 E. Bulgheroni, S. La Seta Catamancio, P. Citterio, M. Galazzi, F, Croce, M. Galli and S. Rusconi Mean values of single target IC50 were 0.224 µM for TPV, 0.004 µM for EFV, 0.027 µM for NFV, 0.393 µM for ABC and 0.080 µM for APV in 14aPre infections; 0.268 µM for TPV, 0.006 µM for EFV, 0.277 µM for NFV, 0.910 µM for ABC and 0.111 µM for APV in CF infections. No toxicity appeared at the highest concentrations used for the entire duration of the experiments. Tipranavir demonstrated activity against a WT HIV-1 isolate and an isolate derived from a heavily PI-experienced patient. Further evaluation of this compound will include combination experiments with dual or triple regimens in vitro. |
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1.2 POST-EXPOSURE PROPHYLAXIS Abstracts P15 thru P83, Pages S21 TO S40 |
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| P15 | 48 WEEK RESULTS OF THE CNAF3007/ECUREUIL OPEN LABEL STUDY: EFFICACY AND SAFETY OF THE TRIPLE NUCLEOSIDE COMBINATION COMBIVIR/ABACAVIR VERSUS COMBIVIR/NELFINAVIR AS FIRST-LINE ANTIRETROVIRAL THERAPY IN HIV-1 INFECTED ADULTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P15 AIDS 2000, Oct 22-26;14(Suppl. 4);S21 S. Matheron1, F. Brun Vezinet1, C. Katlama2, J.M. Livrozet3, D. Sicard4, H. Gallais5, F. Boue6, C. Thiaux7 and J.P. Mamet7, on behalf on the CNAF3007/Ecureuil study group The triple nucleoside combination combivir/abacavir is generally well tolerated first line ART in HIV-1 infected adults, with comparable antiviral activity to a protease inhibitor containing regimen at Week 48. |
| P16 | DIVERGENT INDUCTION FOLLOWED BY LONG TERM CONVERGENT ANTIRETROVIRAL THERAPY IN HIV POSITIVE PATIENTS WITH HIGH RISK OF THERAPY FAILURE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P16 AIDS 2000, Oct 22-26;14(Suppl. 4);S21 Olaf Degen, Jan van Lunzen, Knud Schewe and Hans-Jürgen Stellbrink A regimen of divergent quadruple-drug induction, followed by convergent quadruple-drug maintenance therapy is highly active and well tolerated in patients at high risk of early failure. Prospective trials are needed to compare this approach with standard regimens. |
| P17 | VIRAL RESPONSE AT WEEK 16 PREDICTS FUTURE TREATMENT SUCCESS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P17 AIDS 2000, Oct 22-26;14(Suppl. 4);S21 H.A. Stirnadel1, C. Craig1, A.M. Hill1 and L.J. Wheat2 In conclusion, the differences in the rate of decay from treatment initiation up to week 4 appeared to be an indicator of long-term treatment response. However, suppression of HIV-1 RNA to < 400 copies/ml by week 16 was the most important predictor of a durable response up to week 48. We, therefore, suggest that monitoring week 16 viral load might encourage continuation, change or intensification of therapy. |
| P18 | HAART AND THE BRAIN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P18 AIDS 2000, Oct 22-26;14(Suppl. 4);S22 A. Kandanearatchi, G. Trillo-Pazos, D. King, J. Eyeson, A. Vyakarnam, M. Smith, M. Zukerman and I.P. Everall This data demonstrates that NRTIs can prevent neuronal loss and microglial cell proliferation in this aggregate model infected with HIV. Such protective properties indicate that these agents will be efficacious in the treatment of HIV associated cognitive impairments. Importantly, this model is being used to test which other drugs prevent HIV associated brain damage. |
| P19 | Comparing PI and NNRTI regimens using clinical databases Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P19 AIDS 2000, Oct 22-26;14(Suppl. 4);S22 A.C. Ghani, C.A. Donnelly, A.W. Roddam, W. Henley, R.M. Anderson Not available |
| P20 | RESPONSE TO LOPINAVIR-BASED MULTIDRUG RESCUE REGIMENS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P20 AIDS 2000, Oct 22-26;14(Suppl. 4);S22 M. Harris, W. Stewart, G. Larsen, P.R. Harrigan and J.S.G. Montaner In conclusion, exposure to multiple PIs and mutations associated with PI resistance do not preclude a VL response to multidrug rescue regimens including LPV. |
| P21 | SUCCESSFUL SUBSTITUTION OF PROTEASE INHIBITORS WITH EFAVIRENZ IN PATIENTS WITH UNDETECTABLE PLASMA HIV-1 RNA LEVELS: RESULTS OF A PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL STUDY (DMP 266–049) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P21 AIDS 2000, Oct 22-26;14(Suppl. 4);S22 S. Becker1, A. Rachlis2, J. Gill3, E. DeJesus4, G. Pierone5, L. Kirkland6, S. Koosian7, D. Farina8, D. Labriola8, N. Ruiz8, L. Bessen8, S. Villano8 and the Study 049 Team1 EFV substitution of a PI, in a suppressive PI-containing regimen, successfully maintains full antiretroviral control (plasma HIV-1 RNA levels ≤ 50 copies/ml) and continued increases in CD4 counts up to 24 weeks. |
| P22 | EFFICACY AND SIDE EFFECTS OF EFAVIRENZ: A RETROSPECTIVE CASE REVIEW Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P22 AIDS 2000, Oct 22-26;14(Suppl. 4);S22 A. Cochrane, A. Pithie, D. Kennedy, R. Fox and A. Thomson In conclusion the efficacy of efavirenz based triple therapy prescribed in the Brownlee centre is comparable to published data, but more patients than expected were unable to tolerate the drug. |
| P23 | EFAVIRENZ DOES NOT ADD SIGNIFICANTLY TO A DEEP SALVAGE ANTIRETROVIRAL THERAPY INCLUDING A NOVEL PROTEASE INHIBITOR, WITH OR WITHOUT A NOVEL NUCLEOSIDE ANALOGUE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P23 AIDS 2000, Oct 22-26;14(Suppl. 4);S23 R. Manfredi, E. Rizzo, L. Calza and F. Chiodo The need of salvage antiretroviral strategies is increasingly frequent in HIV-infected patients. A deep rescue therapy including EFZ plus a novel protease inhibitor is not expected to obtain a complete and sustained virologic success, in patients highly experienced with both nucleoside analogues and protease inhibitor-containing HAART, and a concurrent elevated viral load (> 104 copies/ml in our series), probably due to the extensive viral resistance pattern acquired through time. However, the immunological response proved better than the virologic one, as evaluated during a quite prolonged follow-up. The concurrent change of at least one nucleoside analogue may add significantly, especially during the first 6 months of salvage therapy. |
| P24 | NELFINAVIR PLUS EFAVIRENZ IN NAÏVE SUBJECTS WITH HIGH BASELINE VIRAL LOAD AND IN PATIENTS FAILING PIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P24 AIDS 2000, Oct 22-26;14(Suppl. 4);S23 V. Oller, P. Barreiro, V. Soriano and J. González-Lahoz In summary, a quadruple combination including NFV plus EFV provides a significant virologic and immunologic benefit in naïve patients with high baseline VL and, to a lesser extent, in patients failing previous PI-containing combinations. |
| P25 | EFAVIRENZ EXPANDED ACCESS PROGRAM: NORTH AMERICAN EXPERIENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P25 AIDS 2000, Oct 22-26;14(Suppl. 4);S23 D.J. Manion, K.Z. Koziak, D.S. Block, W.C. Montgomery, J.L. Joseph and L.J. Bessen In conclusion, in heavily ARV-experienced patients, EFV was generally well tolerated, with rates of AE-associated discontinuation similar to those observed in clinical trials. Previous treatment with an NNRTI was associated with lesser reductions in plasma HIV RNA levels. |
| P26 | EFAVIRENZ IN END STAGE RENAL DISEASE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P26 AIDS 2000, Oct 22-26;14(Suppl. 4);S23 K.P. Prime1, E.M.A. Jungmann1, M.R. Pakianathan1 and I. Woolfson2 EFV, AZT and 3TC are not known to be nephrotoxic. The Hb drop, if significant, could be accounted for by AZT myelotoxicity or ESRD. EFV is known to cause disruption of LFTs and has potential to interact with Amlodipine. However, the ALP rise may be due to 2° hyperparathyroidism seen in ESRD. EFV, AZT and 3TC were well tolerated, safe and effective in this HIV positive patient on CAPD despite pre-existing high pill burden and potential for drug interaction. Increase in CD4 count and reduction in VL to below 50 copies/ml was achieved at 12 weeks. Sustainability and long term safety of this regimen are yet to be confirmed. |
| P27 | CLINICAL, IMMUNOLOGICAL AND VIROLOGICAL RESPONSE TO EFAVIRENZ IN COMBINATION WITH OTHER ANTIRETROVIRAL DRUGS AMONG HIV-INFECTED ROMANIAN ADULTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P27 AIDS 2000, Oct 22-26;14(Suppl. 4);S24 S. Erscoiu1, D. Ispas1, S. Florescu1, C. Cotiga2, C. Chirculescu2, D. Duiculescu2, P. Calistru1 and E. Ceauşu1 Clinical progression of the disease was registered only in one patient. EFV in different ART combinations demonstrated durable suppression of the disease and VL with CD4 recovery and maintenance over an extended period. |
| P28 | 'MAINTENANCE' HAART WITH SAQUINAVIR HARD GEL, SPONTANEOUSLY REQUESTED BY PATIENTS DECLINING THE PROSECUTION OF A SUCCESSFUL HAART INCLUDING A POTENT PROTEASE INHIBITOR Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P28 AIDS 2000, Oct 22-26;14(Suppl. 4);S24 R. Manfredi and F. Chiodo Although the continuation of an anti-HIV regimen of maximal potency is presently recommended to patients favorably treated with an HAART association containing a potent protease inhibitor, ‘maintenance’ regimens carried out after a heavy induction HAART, and including drugs with an expected lower potency but better tolerability and compliance profiles, deserve some investigation. In fact, a few literature studies dealing with failure of some ‘maintenance’ strategies, were severely limited by short induction periods, or drug associations which were not expected to sustain viral suppression, while a triple combination containing SQV hard gel has not been assessed to date in patients who had a favorable prior response to IDV-, RTV, or NFV-containing HAART. |
| P29 | THERAPEUTIC EFFECTS OF ANTIRETROVIRAL THERAPY REGIMENS ON THE CENTRAL NERVOUS SYSTEM: IMPACT OF DIFFERENT FORMS OF PRETREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P29 AIDS 2000, Oct 22-26;14(Suppl. 4);S24 G. Arendt, H.J. v. Giesen, A. Theisen1 and H. Hefter Despite different forms of pretreatment, HAART has a significant therapeutic effect on the CNS for at least 6 months. |
| P30 | THERAPEUTIC EFFECTS OF ANTIRETROVIRAL THERAPY REGIMENS ON THE CENTRAL NERVOUS SYSTEM: VALUE OF DIFFERENT THERAPY REGIMENS IN THERAPY-NAÏVE PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P30 AIDS 2000, Oct 22-26;14(Suppl. 4);S25 H.J. v. Giesen, A. Theisen1, H. Hefter and G. Arendt In therapy-naïve patients combinations including two nucleoside analogues with or without a protease inhibitor showed a comparable therapeutic effect on the CNS. |
| P31 | EFFECTIVE LONG-TERM REDUCTION OF CEREBROSPINAL FLUID VIRAL LOAD BY HAART IN ANTIRETROVIRAL NAÏVE HIV-1 INFECTED INDIVIDUALS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P31 AIDS 2000, Oct 22-26;14(Suppl. 4);S25 M. Gisslén, L. Hagberg and B. Svennerholm HAART effectively reduces CSF viral load for at least 2–4 years in antiretroviral naïve HIV-1 infected individuals without neurological symptoms. |
| P32A | INDINAVIR PLUS RITONAVIR AS SALVAGE THERAPY IN HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P32A AIDS 2000, Oct 22-26;14(Suppl. 4);S25 I. Santos, P. González-Ruano and J. Sanz 1.-We observed a significant benefit in the viral load decrease, and remained stable over follow-up. 2.-The benefit was more important in the patients that had never taken RTV and/or IDV, but had experienced protease inhibitors. 3.-IDV plus RTV in combination at the mentioned doses may represent a good therapeutic option in patients with multiple failures to HAART. |
| P32B | ADVERSE EVENTS OF INDINAVIR PLUS RITONAVIR AS SALVAGE THERAPY IN HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P32B AIDS 2000, Oct 22-26;14(Suppl. 4);S25 I. Santos, P. González-Ruano and J. Sanz We observed a high incidence of adverse events and a high percent of withdrawal of the medication study, but the efficacy in some appropriated cases can make this combination very useful. |
| P33 | PERFORMANCE OF RITONAVIR PLUS INDINAVIR AS PART OF SALVAGE REGIMENS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P33 AIDS 2000, Oct 22-26;14(Suppl. 4);S26 P. Barreiro, V. Oller, V. Soriano and J. González-Lahoz In conclusion, the combination of RTV+IDV constitutes a potent option for salvage interventions. These benefits are counterbalanced with a high incidence of adverse effects, which could be explained by the overlapping toxicity profile of RTV and IDV, and the poor tolerance the RTV liquid formulation. |
| P34 | A DUAL PROTEASE INHIBITOR (PI)-BASED REGIMEN INCLUDING INDINAVIR (IDV) 800 MG TWICE DAILY (BID) PLUS RITONAVIR (RTV) 200 MG BID SHOWS EARLY PROMISE IN LOWERING SERUM HIV RNA LEVELS IN HIV-INFECTED PERSONS WITH EXTENSIVE PROTEASE (PR) MUTATIONS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P34 AIDS 2000, Oct 22-26;14(Suppl. 4);S26 R.D. MacArthur, J.M. Kosmyna and L.R. Crane The 0.7 log10 copies/ml (5-fold) drop in serum HIV RNA level and 20% increase in CD4+ lymphocyte cell count at 2 months, if sustained, suggest that many HIV-infected persons previously treated with PIs may benefit from this IDV + RTV-based AR regimen. |
| P35 | IDV/RTV 800/200 MG BID AS SALVAGE THERAPY FOR PI FAILURES: MERCK 088 Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P35 AIDS 2000, Oct 22-26;14(Suppl. 4);S26 M. Robertson1, R. Campo2, D. Butcher3, D. Johnson4, R. Larsen4, J. Eron4, P. Piliero6, D. Marino1, M. Nessley1, R. Leavitt1 In this study, the majority of patients responded to therapy with IDV 800 mg + RTV 200 mg. This IDV/RTV regimen may have a role as salvage therapy in patients who have failed a PI containing regimen, including patients who have failed IDV. |
| P36 | DOUBLE PI STUDY: INDINAVIR Q8H + D4T/3TC BID VERSUS INDINAVIR/NELFINAVIR BID + D4T/3TC BID (MERCK PROTOCOL 079) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P36 AIDS 2000, Oct 22-26;14(Suppl. 4);S26 J. Nadler1, W.J. Fessel2, L. Kirkland3, S. Maloney4, N. Bohidar4, H.Wilson4, E. Edelstein4 and J. Schranz4 Preliminary 24-week results suggest both bid/4 DR and q8h/3 DR exhibit potent antiviral activity. Updated information including response by baseline stratum will be presented. |
| P37 | DIRECT STUDY: A MULTICENTER, OPEN LABEL, 24-WEEK PILOT STUDY WITH A 24-WEEK EXTENSION TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF INDINAVIR/RITONAVIR (800/100) BID IN COMBINATION WITH D4T PLUS 3TC IN HIV-INFECTED INDIVIDUALS (MERCK PROTOCOL 094) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P37 AIDS 2000, Oct 22-26;14(Suppl. 4);S27 M. Fischl1, M. Watkins2, B. Young3, J. Fessel4, N. Bohidar5, H. Wilson5, K. Guckert5, J. Schranz5 Overall the regimen was generally well tolerated. Five of 50 patients (10%) have developed nephrolithiasis. At the time of this summary 42 patients either completed or are continuing. Two patients have 2) pneumonia, dehydration and acute renal failure. Preliminary data demonstrated that IDV-RTV (800/ 100) bid + d4T/3TC was generally well-tolerated with potent antiretroviral activity. Additional data will be presented. |
| P38 | BID FIRST-LINE RITONAVIR/INDINAVIR 24 WEEK RESULTS: GERMAN MULTICENTER STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P38 AIDS 2000, Oct 22-26;14(Suppl. 4);S27 A. Wickesberg1, P. Gute2, L. Locher2, B. Salzberger3, A. Wöhrmann3, A. Adam4, L. Weitner4, F. Bergmann5, K. Schliefer1 and J.K. Rockstroh1 for the German Ritonavir/Indinavir Study Group Our preliminary data suggest that even in the presence of high median baseline HIV-RNA levels the protease inhibitor combination RTV/IDV (2 × 100/2 × 800 mg) plus double/triple nucleoside therapy appears effective and safe in therapy naïve patients based on short-term treatment up to week 24. Nephrolithiasis occurred in 15% and therefore patients need extra hydration. The study is ongoing and further clinical and laboratory data will be presented. |
| P39 | HIGH EFFICACY OF INITIAL 3-CLASS, 4-DRUG ANTIRETROVIRAL THERAPY (ART) IN THERAPY-NAÏVE HIV PATIENTS WITH HIGH VIRAL LOAD Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P39 AIDS 2000, Oct 22-26;14(Suppl. 4);S27 F. Meienberg1, H.C. Bucher1, P. Taffé2, M. Rickenbach2 and M. Battegay1 for the Swiss HIV Cohort Study (SHCS) In patients with very high viral load clinicians may consider ART with an initial 3-class, 4-drug regimen due to high efficacy in terms of viral suppression and CD4 cell increase, although results from controlled studies are pending. |
| P40A | EFFICACY OF AMPRENAVIR (APV) 600 MG PLUS LOW-DOSE RITONAVIR (RTV) IN CLINICAL PRACTICE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P40A AIDS 2000, Oct 22-26;14(Suppl. 4);S28 A.D. Luber1,2, R. Stryker 1,2, J. Burdick 1,2, M.M. Berrey3, O. Naderer3 and A. Scarsella1 These data suggest that combination ART regimens of APV 600 mg/low dose RTV appears promising for the treatment of antiretroviral experienced HIV-infected individuals. Prospective, multicenter trials evaluating APV600/RTV100 bid are currently underway. |
| P40B | SUSTAINED VIRAL SUPPRESSION WITH AMPRENAVIR PLUS RITONAVIR IN COMBINATION WITH ABACAVIR/ZIDOVUDINE/LAMIVUDINE IN HEAVILY PRETREATED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P40B AIDS 2000, Oct 22-26;14(Suppl. 4);S28 P. Gute1, L. Locher1, A. Carlebach2, T. Lutz2, S. Staszewski2 and V. Miller2 This preliminary study analysis indicates that salvage treatment based on amprenavir/ritonavir plus abacavir appears to be well tolerated, and results in a favourable and sustainable virologic response in patients with extensive prior antiretroviral exposure. The role of viral drug susceptibility will be investigated. |
| P41 | RITONAVIR (RTV)/AMPRENAVIR (APV) COMBINATION THERAPY IN HIV INFECTED PATIENTS WHO FAILED SEVERAL PROTEASE INHIBITOR CONTAINING REGIMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P41 AIDS 2000, Oct 22-26;14(Suppl. 4);S28 C. Katlama, L. Schneider, R. Agher, C. Delaugerre, V. Calvez, M. Legrand and R. Tubiana This pilot retrospective study shows that in patients with multiple failures to PI containing regimen, RTV/AMP appears as a potent antiviral option with a median 1.6 log10 reduction in VL after 12 weeks. |
| P42 | DIFFERENCES IN VIRAL LOAD OUTCOMES AT 90, 180 AND 170 DAYS IN PROTEASE INHIBITOR (PI)-NAÏVE PATIENTS TREATED WITH DUAL VERSUS SINGLE THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P42 AIDS 2000, Oct 22-26;14(Suppl. 4);S29 D. Butcher1, S. Mayer2, C. de Guzman3, E. Hamel3 and D. Lapins3 The dual PI cohort experienced significantly greater log VL decreases at 90, 180 and 270 days than the single PI cohort, regardless of therapy switching during this time period. These results suggest that patients with no prior PI experience can benefit from first-line dual PI therapy. Additional retrospective data and prospective controlled clinical trials are needed to strengthen these conclusions. |
| P43 | ABT-378/RITONAVIR (ABT-378/R) AND EFAVIRENZ: ONE YEAR SAFETY/EFFICACY EVALUATION IN MULTIPLE PI EXPERIENCED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P43 AIDS 2000, Oct 22-26;14(Suppl. 4);S29 J. Rockstroh1, S. Brun12, J. Sylte12, Y. Xu12, N. Clumeck2, A. Lazzarini3, P.M. Girard4, S. Becker5, A. Telenti6, F. Bergmann7, S. Danner8, D. Ho9, R. Tubiana10, G. Carosi1, R. Bertz12, A. Hsu12, D.J. Kempf12 and E. Sun12 for the M98–957 study The safety and efficacy of ABT-378/r and efavirenz plus NRTIs is encouraging in patients with extensive PI experience. |
| P44 | EVALUATION OF ABT-378/RITONAVIR (ABT-378/R) BASED SALVAGE REGIMES IN A COHORT OF HIV-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P44 AIDS 2000, Oct 22-26;14(Suppl. 4);S29 J.N. Day, A.J. Uriel, R. Daintith, E.M. Dunbar, D.W. Denning, E.G.L. Wilkins and A. Bonington Our data suggests that ABT-378/r is well tolerated with 85% of patients achieving a reduction in viral load of greater than 1.0 log by 4 weeks. Phenotypic evidence of resistance to more than one PI suggests a less favourable response to ABT-378/r. |
| P45 | SAFETY AND EFFICACY OF ABT 378/R IN THE GERMAN EXPANDED ACCESS PROGRAM (EAP) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P45 AIDS 2000, Oct 22-26;14(Suppl. 4);S29 E. Voigt, J.C. Wasmuth, D. Braitinger, B. Kupfer1, R. Kaiser2, J.K. Rockstroh ABT 378/r is a highly active antiretroviral drug even in heavily pretreated patients with high level resistance. The overall rate of adverse events is low. Our preliminary data shows no evidence of rapid developing resistances in patients virologically failing ABT 378/r. However further data is required to allow reliable conclusions on resistance under ABT 378/r. |
| P46 | ABT-378/RITONAVIR (ABT-378/R) IN ANTIRETROVIRAL NAÏVE HIV+ PATIENTS: FOLLOW-UP BEYOND 2 YEARS AND VIRAL LOAD SUPPRESSION BELOW 3 COPIES/ML Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P46 AIDS 2000, Oct 22-26;14(Suppl. 4);S30 R. Stryker1, S. Brun13, M. King13, T. Marsh13, R. Murphy2, C. Hicks3, J. Eron4, J. Thommes1, R. Gulick5, M. Glesby5, M. Thompson6, C. White7, C. Benson8, M. Albrecht9, H. Kessler10, K. Real12, A. Japour12, L. Perrin11 and E. Sun12 for the M97.720 Study Group ABT-378/r + d4T + 3TC exhibits durable antiviral activity beyond two years of treatment in treatment-naïve HIV-infected patients. |
| P47 | RITONAVIR 400 MG BID COMPARED WITH RITONAVIR 600 MG BID IN PROTEASE INHIBITOR-NAÏVE SUBJECTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P47 AIDS 2000, Oct 22-26;14(Suppl. 4);S30 M. Sension1, G. Beall2, D. Parenti3, P. Keiser4, E. Yakim5, K. Selness6 and M.F. Giordano7 When combined with d4T and 3TC over a 48-week pilot study, RTV 400 mg bid did not statistically significantly differ from RTV 600 mg bid in its antiviral activity. Fewer patients discontinued the study for adverse events in the RTV 400 mg bid arm. An adequately powered, controlled study would be needed to determine the equivalence of these two regimens. |
| P48 | DUAL PI-CONTAINING REGIMEN WITH NELFINAVIR (NFV)/SAQUINAVIR (SQV) AT A SINGLE HIV OUTPATIENT CLINIC Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P48 AIDS 2000, Oct 22-26;14(Suppl. 4);S30 M. Vazquez, H. Perez, C. Zala and P. Cahn Overall, dual PI-based therapy with NFV/SQV was well tolerated and effective in both naïve and PI experienced patients. |
| P49 | EFFICACY OF AMPRENAVIR, RITONAVIR AND EFAVIRENZ IN TREATMENT EXPERIENCED HIV-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P49 AIDS 2000, Oct 22-26;14(Suppl. 4);S31 K. Römer, B. Salzberger, C. Franzen, D. Waldschmidt and G. Fätkenheuer The combination of amprenavir, ritonavir and efavirenz is well tolerated and shows good antiretroviral activity in a substantial proportion of patients with virological failure to their previous regimens. |
| P50 | SWITCHING FROM PROTEASE INHIBITORS (PI) TO EFAVIRENZ (EFV) IN PATIENTS WITH UNDETECTABLE VIRAL LOAD: IMPACT ON CONSECUTIVE CD4+ CELL COUNT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P50 AIDS 2000, Oct 22-26;14(Suppl. 4);S31 E. Lauenroth-Mai1, J. Bogner2 and B. Salzberger3 Due to the nonrandomized nature of this retrospective analysis, the results of significance analysis are rather descriptive than confirmatory. Still they indicate that the substitution from PI to EFV in subjects with sustained undetectable plasma HIV RNA levels may provide an immunologic benefit. This observation needs to be confirmed by further prospective studies. |
| P51 | SWITCHING PI TO NNRTI: EVALUATION OF THE EFFICIENCY ON UNDETECTABLE PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P51 AIDS 2000, Oct 22-26;14(Suppl. 4);S31 F. Chauvelot, D. Blancher, M. Walter, J. Gaillat and J.P. Bru The results of this therapeutic alternative are interesting. Nevertheless, they must be reassessed and confirmed by a wider and longer study. |
| P52 | IMMUNE RESPONSE TO A FIRST HAART REGIMEN: NNRTI VERSUS PI-BASED COMBINATIONS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P52 AIDS 2000, Oct 22-26;14(Suppl. 4);S31 P. Barreiro, V. Soriano, E. Casas and J. González-Lahoz In conclusion, an abrupt increase in CD4 cells occurs shortly after HAART is introduced. This response mainly reflects CD4 cell redistribution. Late increases in CD4 counts, mostly due to the naïve subset, seem to be higher in subjects experiencing a good virological response under PI-containing regimens than among those being under NNRTIs. |
| P43 | STEPWISE TREATMENT DISCONTINUATION IN PATIENTS SHOWING GOOD VIROLOGICAL CONTROL ON TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P53 AIDS 2000, Oct 22-26;14(Suppl. 4);S31 P. Barreiro, C. de Mendoza, V. Soriano and J. González-Lahoz In conclusion, HU–ddI might represent an optional therapy after a sustained success on HAART. The presence of persistent low-grade virus replication on HU–ddI could elicit CD4–CD8 lymphocyte responses which in the long-term might allow to control HIV replication without any antiviral treatment. |
| P54 | EFFICACY OF NELFINAVIR (NFV) SALVAGE WITH A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI) IN HEAVILY PRE-TREATED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P54 AIDS 2000, Oct 22-26;14(Suppl. 4);S32 J.G. Baril, P. Junod, F. Laplante, D. Tessier, P. Cote, S. Dufresne and Y. Parent Therefore, we conclude that NFV in combination with DLV or EFV offers effective salvage in heavily pre-treated patients. Although significance could not be determined due to small sample size, a lower mean duration of HIV/AIDS or a lower mean number of prior HAART regimens appeared to be associated with positive response. |
| P55 | EFFICACY AND TOLERABILITY OF TWICE DAILY ZALCITABINE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P55 AIDS 2000, Oct 22-26;14(Suppl. 4);S32 F. Antunes1 and M. Doroana2 on behalf of the HIVBID Study Group In conclusion, this interim analysis suggest that zalcitabine is effective and well tolerated when administered twice daily, with similar antiretroviral activity to that of the more commonly used regimen of 3TC/ZDV plus a PI for all parameters evaluated. |
| P56 | IMPACT OF ABACAVIR ON AN HIV OUTPATIENTS' CLINIC INTENSIFICATION OF DUAL NUCLEOSIDE THERAPY IN LONG-TERM TREATED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P56 AIDS 2000, Oct 22-26;14(Suppl. 4);S32 A. Capetti, C. Magni, P. Bonfanti and M.C. Vivirito The numbers are still small and this is an historical population that is unlikely to grow very much in size (at present dual nucleoside therapy is proposed only to psychiatric patients who are poorly compliant and absolutely need antiretroviral therapy). However our data show the clear potency of abacavir being added as the only new drug in a setting where previous nucleoside exposure should have reduced viral sensitivity to the drug. Unfortunately at the time the study was started baseline resistance testing was not taken into account. |
| P57 | SHOULD THE M184V MUTATION IN RT BE MAINTAINED AS A COMPONENT OF HIV TREATMENT STRATEGIES? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P57 AIDS 2000, Oct 22-26;14(Suppl. 4);S33 Mark A. Wainberg and Matthias Gotte These data provide support for the notion that the effectiveness of ABC and ZDV may be sustained, at least temporarily, in the presence of the M184V mutation. However the notion that M184V can confer benefit remains hypothetical and clinical trials are required to validated disprove this hypothesis. |
| P58 | OPEN, MULTICENTRIC RANDOMIZED STUDY TO EVALUATE EFFICACY AND SECURITY OF NELFINAVIR 750 MG TID VERSUS 1250 MG BID, ASSOCIATED WITH 3TC AND D4T, IN HIV INFECTED PATIENTS: CONCOMITANT EVALUATION OF HIV GENOTYPING AND COMPLIANCE TO TREATMENT. ESPARTA 001 –'PAULISTA' STUDY FOR ANTIRETROVIRAL THERAPEUTIC REGIMEN EVALUATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P58 AIDS 2000, Oct 22-26;14(Suppl. 4);S33 Marilia S. Oliveira, Olavo H.M. Leite, Jane I. Varandas, David E. Uip and ESPARTA Group We concluded that NFV 750 mg tid and 1250 mg bid, associated with 3TC and d4T, have similar patterns of efficacy in 12 weeks of treatment. |
| P59 | ABACAVIR (ABC) BASED TRIPLE NUCLEOSIDE ANALOGUES (NRTIS) VERSUS PROTEASE INHIBITOR (PI) CONTAINING REGIMENS IN ANTIRETROVIRAL NAÏVE PATIENTS WITH A CD4 COUNT OF LESS THAN 100 AND/OR AIDS: OBSERVATIONAL DATA FROM THE FRANKFURT COHORT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P59 AIDS 2000, Oct 22-26;14(Suppl. 4);S33 C. Rottmann1, V. Miller1, A. Haberl1, A. Muller1, H. Rabenau2, S. Staszewski1 In this observational study of treatment response with heavily immunocompromised patients, no differences regarding virological, immunological and clinical treatment response were detected between the two groups. However further studies with larger patient cohorts and longer follow-up period are required. |
| P60 | DOES THE CHOICE BETWEEN NNRTI OR PI BASED INITIAL HAART PREDICT VIROLOGICAL SUPPRESSION AT 24 WEEKS IN A CLINICAL SETTING? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P60 AIDS 2000, Oct 22-26;14(Suppl. 4);S33 G.V. Matthews, S. Mandalia, M. Nelson, M. Bower and B.G. Gazzard This is the first cohort analysis to support clinical trial data on the potential superiority of an NNRTI combination in initial HAART regimens and may reflect the greater tolerability of these combinations. |
| P61 | PROTEASE INHIBITOR (PI) SPARING REGIMENS IN PATIENTS WITH ADVANCED HIV DISEASE (CD4 < 200/MM3) AND NAÏVE FOR ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P61 AIDS 2000, Oct 22-26;14(Suppl. 4);S34 D. Konopnicki, H. Ait Mohand, M. Tpilo-Zavala, E. Chiesa, P. Bossi, M.A. Valantin, C. Delaugerre, V. Calvez, F. Bricaire and C. Katlama These preliminary results suggest that first line PI sparing regimens using NRTIs and NNRTI combination are highly effective, safe and appropriate to patients with advanced HIV disease regarding to compliance and heavy concomitant therapies. |
| P62 | MAINTENANCE OF VIROLOGICAL SUPPRESSION IN PATIENTS SWITCHED FROM INDINAVIR (IDV) TO NELFINAVIR (NFV) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P62 AIDS 2000, Oct 22-26;14(Suppl. 4);S34 E. Lefebvre1 and S. Shafran2 Most commonly cited reasons for switch to NFV were: physician preference (23.2%), GI upset (19.6%), adherence issues (19.6%) and urolithiasis (14.3%). To date 30 patients remain on the same NFV regimen; 13 changed to a different regimen and four stopped therapy altogether. Patients maintained further virological suppression (on average 55.7 weeks) after switching to NFV, which provided a total protease inhibitor treatment duration of approximately 110 weeks. Therefore, in patients intolerant of IDV, who are controlled virologically, switching to NFV is a reasonable option. |
| P63 | PREDICTORS OF VIROLOGICAL FAILURE AMONG PATIENTS STARTING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P63 AIDS 2000, Oct 22-26;14(Suppl. 4);S34 E. Florence, C. Dreezen, P. Desmet, E. Smets, A. De Roo, R. Colebunders Risk factors for virological failure were at baseline, a younger age, a longer duration of seropositivity, a high viral load, a low CD4 count and a low BMI. |
| P64 | AN ANALYTIC REVIEW OF RANDOMIZED, CONTROLLED TRIALS OF SELECTED HAART REGIMENS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P64 AIDS 2000, Oct 22-26;14(Suppl. 4);S35 C. Renz, P. Foley, T. Ashraf, E. Sun, and M. Luo This review study suggests that efficacy differences exist among HAART regimens, and tolerability of agents may present a significant clinical problem. A lack of uniform statistical reporting methods can bias comparisons of published results. |
| P65 | VIROLOGICAL SUPPRESSION IN PATIENTS STARTING A SECOND-LINE HAART REGIMEN AFTER STOPPING THEIR FIRST HAART REGIMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P65 AIDS 2000, Oct 22-26;14(Suppl. 4);S35 A. De Luca1, A. Cozzi Lepri2, A. d’ Arminio Monforte1, A.N. Phillips2, F. Alberici1, M. Vigevani1, A. Sinicco1, V. Colangeli1, F. Menichetti1, F. Ghinelli1 and M. Moroni1 Although larger numbers of individuals must be studied before firm conclusions can be drawn, these findings provide insights into the factors affecting response to second HAART regimens in patients who previously received only HAART. |
| P66 | EFFICACY AND TOLERABILITY OF HYDROXYUREA CONTAINING SALVAGE ANTIRETROVIRAL REGIMENS IN THE MANAGEMENT OF HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P66 AIDS 2000, Oct 22-26;14(Suppl. 4);S35 P. Harrington, S. Clarke, M. Ryan, C. Bergin and F. Mulcahy Preliminary data suggest that HU containing salvage regimens are efficacious, consistent with expectations for a cohort of heavily pretreated patients with advanced HIV disease on complicated treatment schedules. HU-containing regimens were associated with significant treatment related morbidity. HU therapy should be used with extreme caution in these patients and the importance of close surveillance cannot be underestimated. Early evidence of haematological toxicity warrants prompt dose reduction or treatment interruption to avert serious drug induced toxicity and consequent morbidity. |
| P67 | A RANDOMIZED, CONTROLLED CLINICAL TRIAL (RACING-TRIAL) COMPARING TWO TREATMENT STRATEGIES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P67 AIDS 2000, Oct 22-26;14(Suppl. 4);S35 K. Arasteh1, A. Baumgarten1, A. Masuhr1, V. Simon1, T. Zwingers2, A. Moll3, E. Lauenroth-Mai3, C. Moecklinghoff4, M. Kurowski1, M. L’ Age1 VL and CD4 T-lymphocyte count showed no statistically significant difference in the ZDV, ddC, SQV versus the ZDV, 3TC, NFV group, until week 80. Early treatment failures are highly predictable at baseline by the presence of mutations in the RT-gene and SQV drug levels. Late failures appear to depend on low drug levels during therapy, pre-existing mutations, and newly developed mutations during treatment and other known risk factors such as high HIV-RNA at baseline. The mutation pattern between the two arms of patients who had failed (VL > 1000 c/ml) treatment regimens between week 52 and 104 are incongruent. |
| P68A | DRUG HOLIDAYS (DH) IN HIV+ PATIENTS: CLINICAL ISSUES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P68A AIDS 2000, Oct 22-26;14(Suppl. 4);S36 C. Hoffmann, E. Wolf, J. Schardt, A. Ulmer, M. Procaccianti, F. Mosthaf, S. Mueller, C. Moser-Juenemann, E. Gersbacher, E. Jaegel-Guedes and H. Jaeger for the HOKI-study group During DH CD4 cells declined by an average of –70/µl. At month 6, CD4 counts had returned to BL values. In the control patients remaining on ART with a BL VL below detection, a noteworthy CD4 cell increase of +69/µl was observed at month 6. DH were accompanied by a significant increase in VL. However, in 58% a VL < 50 copies/ml was reinstated at month 6. Overall, metabolic parameters, i.e. G-GT, total cholesterol and triglycerides, improved during DH. In this study drug holidays did not lead to an increased incidence of new AIDS defining events during the first 6 months of follow-up. |
| P68B | CHANGING ANTIRETROVIRAL THERAPY IN ENGLISH NPMS-HHC CLINICS 1998–1999: WHY DO PEOPLE STOP? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P68B AIDS 2000, Oct 22-26;14(Suppl. 4);S36 E.J. Beck, S. Mandalia, D. Parmar, M. Fisher, A. Pozniak, A. Tang, M. Youle and B. Gazzard for the NPMS-HHC Steering Group The proportion of individuals who had stopped triple or more ART for reasons other than changes in VL, CD4 count or developing Sx was substantial. This may be due to intolerance to particular drug combinations, people going on 'drug holidays' or other reasons which remain to be elucidated. |
| P69 | THE INSUFFICIENT SUPPRESSION OF VIRAL LOAD BY SAQUINAVIR HARD GEL IS REVERSIBLE: A RETROSPECTIVE COHORT STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P69 AIDS 2000, Oct 22-26;14(Suppl. 4);S36 S. Jensen-Fangel1, O. Kirk2, A. Blaxhulat3, J. Gerstoft4, C. Pedersen5, F.T. Black1, J.D. Lundgren2 and N. Obel1 We conclude that at a short-term perspective the suboptimal effect of saquinavir-hgc seems reversible after optimising the antiretroviral regimen. |
| P70 | RISK FACTORS FOR HIV+ PREGNANT WOMEN TO ACHIEVE VIRAL LOAD (VL) UNDER 1000 (COPIES/ML) AT DELIVERY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P70 AIDS 2000, Oct 22-26;14(Suppl. 4);S37 M.C.S. Almeida, A. Castelo Filhi, M.J.R. Vaz and G.R. Waghabi A more comprehensive approach to HIV prevention and care in HIV+ pregnant women would include treatment for both women and infants. In order to define risk factors for virologic response to combined therapy and its safety, more studies are needed, specially in the set of the developing nations. |
| P71 | ANTIVIRAL THERAPY AND MANAGEMENT OF HIV IN PREGNANT WOMEN OF THE FRANKFURT HIV-COHORT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P71 AIDS 2000, Oct 22-26;14(Suppl. 4);S37 A. Haberl1, A. Carlebach1, U. Engelbach1, C. Faul-Burbes2, R. Linde3 and S. Staszewski1 Although no case of HIV transmission has been observed so far, there was a high rate of complications in this cohort of women. Information on the use of antiretroviral drugs, complications and long-term follow-up is lacking. We recommend the establishment of a multicenter register for the antiretroviral therapies in pregnant HIV-infected women and long-term follow-up for mothers and children. |
| P72 | SAFETY AND TOXICITY IN 14 HIV-1 POSITIVE PREGNANT WOMEN USING SEVERAL ANTIRETROVIRAL TREATMENT REGIMENS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P72 AIDS 2000, Oct 22-26;14(Suppl. 4);S37 M. Pizzuto, E. Chiesa, L. Corsico, M. Piazza, A. Bandera, L. Testa, S. Melzi, B. Castelnuovo, S. Sollima, A. d’ Arminio Monforte, M. Moroni and T. Bini All treatments were well tolerated by women and all tested infants resulted HIV negative by PCR at the 3rd month after birth, proving the efficacy in preventing vertical transmission and the safety of the different antiretroviral regimens in this small cohort. The mother of the only child who died was probably non-compliant to ARV therapy in spite of a resistance genotype test showing no resistance mutations to the drugs prescribed, she had lowering CD4 counts (from 195/µl at 8th week to 89/µl at 28th week) and increasing HIV-1 plasma viremia (from 6500 cp/ml at 8th week to 95 000 cp/ml at 28th week) during pregnancy. |
| P73 | COMBINATION ANTI-HIV THERAPY IN PREGNANCY IS NOT ASSOCIATED WITH LOW BIRTH WEIGHT INFANTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P73 AIDS 2000, Oct 22-26;14(Suppl. 4);S38 E. Visconti1, L. Pastore Celentano1, C. Fundarò2, O. Genovese2, P. Villa3, E. Tamburrini1 and 'Gruppo multidisciplinare per la cura della dona HIV positiva in gravidanza e del suo bambino' A highly effective anti-HIV therapy should be offered to all HIV positive pregnant women in order to prevent vertical transmission, without (or with minor) side effects on the newborn. In consideration of the increasing number of HIV infected women treated with PIs, this protocol could be reliably used in HIV pregnant women, in order to have the ‘best’ treatment of the mother too. |
| P74 | DELAVIRDINE (DLV) IS EFFICACIOUS IN HEAVILY PRETREATED PI-EXPERIENCED SALVAGE REGIMENS (SR) IN AN URBAN CLINIC SETTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P74 AIDS 2000, Oct 22-26;14(Suppl. 4);S38 B. Kopp Hutzler1, F. Visnegarwala2, P. Sajja2, P. Fasano2, B. Sepcie2 and A.C. White Jr2 In an urban clinic, a high proportion of NNRTI-naïve patients treated with DLV and PI-containing salvage regimens achieved VL< 400 copies/ml. The durability of VL response was sustained in more than a third of these patients, and is perhaps related to the PI-enhancing effects of DLV. |
| P75 | FACTORS RELATED TO VIROLOGICAL FAILURE IN A COHORT OF INJECTING DRUG USERS (IDU) TREATED WITH A COMBINATION THERAPY INCLUDING TWO NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTI) AND NEVIRAPINE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P75 AIDS 2000, Oct 22-26;14(Suppl. 4);S38 M. Zaccarelli, A. Barracchini, P. De Longis, G. Liuzzi, F. Soldani, G. Ippolito and A. Antinori Our experience suggests that a simplified HAART regimen including 2 NRTIs and nevirapine in IDUs is effective and exhibits a relatively low frequency of side effects and interaction with methadone. However, our results also show that continuing injecting drug use, low adherence and treatment breaks, related to the drug users lifestyle, are the main factors that can lead to treatment failure and therefore to NNRTI class resistance. |
| P76 | INTERMITTENT THERAPY AFTER D4T/DDI/NVP ± HYDROXYUREA (HU) INITIATED DURING PRIMARY HIV INFECTION (PHI) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P76 AIDS 2000, Oct 22-26;14(Suppl. 4);S38 C. Zala, C. Ochoa, M.B. Bouzas, A. Gun, H. Perez, H. Salomon and P. Cahn Our preliminary results suggest that interruption of therapy after initial treatment of PHI may allow successful reintroduction of the original regimen while reducing drug exposure. |
| P77 | ABACAVIR + EFAVIRENZ PLUS BACKGROUND COMBINATION THERAPY AS A SALVAGE REGIMEN IN HIV-INFECTED INDIVIDUALS: EFFICACY AND SAFETY AFTER 48 WEEKS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P77 AIDS 2000, Oct 22-26;14(Suppl. 4);S39 C. Herhaus, J.-C. Wasmuth, K. Römer1, B. Salzberger1, K. Schliefer and J.K. Rockstroh These data suggest a reasonable antiretroviral efficacy of the abacavir +efavirenz salvage regimen. The long term tolerability to this regimen appears to be good, although the drop-out rate due to skin rashes/hypersensitivity is high during the first 4 weeks of treatment. |
| P78 | RESULTS OF AN OPEN LABEL STUDY OF ZERIT, VIDEX, CRIXIVAN AND NORVIR IN PROTEASE INHIBITOR NAÏVE HIV-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P78 AIDS 2000, Oct 22-26;14(Suppl. 4);S39 R. Anderson, D. Williamson, N. Corey, E. Shultz and D. Lenzi Despite the problems with adherence, for those patients that continue on the protocol, this treatment regime offers an effective anti-retroviral treatment with a convenient dosing schedule. Long term side effects of this regime as well as efficacy among the different dosage regimes remain to be seen but short term side effects appear to be manageable for most patients. |
| P79 | INITIAL ANTIRETROVIRAL REGIMES IN A HIV POSITIVE PATIENT POST RENAL TRANSPLANT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P79 AIDS 2000, Oct 22-26;14(Suppl. 4);S39 R. Anderson, N. Corey, E. Navarro, D. Williamson, E. Shultz, T. Cresswell and J. Meneski He was started on an anti-retroviral regime immediately post transplant that included stavudine (zerit), lamivudine (epivir) and nevirapine (viramune) all at standard adult dosages. His viral load has remained less than 50 and his CD4 cell counts have remained between 400 and 800 since starting this regime immediately post renal transplant. |
| P80 | TOLERABILITY OF A NOVEL APPROACH TO SALVAGE THERAPY FOR AIDS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P80 AIDS 2000, Oct 22-26;14(Suppl. 4);S39 C. Leen1, S. Shaunak2, C. Steinhart 3and the SAINT, TITAN and ATLAS study Investigators General patient acceptability has been high. These studies demonstrate that administering dextrin sulphate via the intraperitoneal route is feasible as salvage or adjunctive therapy for AIDS. |
| P81 | LONG-TERM THERAPY WITH STAVUDINE, DIDANOSINE AND NELFINAVIR IN NAÏVE AND TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS: RESULTS AT 84 WEEKS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P81 AIDS 2000, Oct 22-26;14(Suppl. 4);S40 S. Esser and M. Goos Long-term triple therapy with d4T, DDI and NFV is more effective and better tolerated in previously untreated subjects than in ART experienced patients. Longer follow-up trials with different regimens are needed to decide which treatment strategy achieves a more durable viral load suppression with less long-term toxicity. |
| P82 | LONG-TERM EFFICIENCY AND/OR FAILURE IN THE ARV TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P82 AIDS 2000, Oct 22-26;14(Suppl. 4);S40 Eugenia Muja, Sorin Rugina, Mariana Codarcea and Eugenia Basca Abstract not reproduced at Author’s request |
| P83 | CLINICAL SECURITY OF COMBINED ANTIRETROVIRAL THERAPY WITH HYDROXIUREA (HU) IN NAÏVE HIV-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P83 AIDS 2000, Oct 22-26;14(Suppl. 4);S40 C. Rodriguez, M. Maidana, A. Capurro, L. Morganti and L. Boffi Lissin Abstract not reproduced at Author’s request |
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1.3 POST-EXPOSURE PROPHYLAXIS Abstracts P84 thru P89, Pages S40 TO S42 |
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| P84 | ANYONE FOR POST-SEXUAL EXPOSURE PROPHYLAXIS? A SURVEY OF VIEWS OF HIV POSITIVE PEOPLE IN WALES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P84 AIDS 2000, Oct 22-26;14(Suppl. 4);S40 M.R. Browning, C.M. Rees and M.R. Evans Unprotected sex between HIV positive people and HIV negative or unknown status partners occurs not infrequently. Considerable interest can be anticipated if PEPS becomes available, particularly from regular HIV negative partners of positive people. Clear guidelines on risk assessment and indications for prescribing need to be available for both staff and patients. As important, there needs to be a service available to people reporting unsafe sex that provides counselling, advice on safer sex, baseline HIV testing and screening for other sexually transmitted infections, even if PEPS is not recommended. |
| P85 | HIV POST-EXPOSURE PROPHYLAXIS: INFLUENCE OF THE MODE OF EXPOSURE ON THE COMPLIANCE AND TOLERANCE OF THE PROCEDURE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P85 AIDS 2000, Oct 22-26;14(Suppl. 4);S41 I. Gueit, Y. Debab, C. Fartoukh, P. Abboud, F. Borsa-Lebas and F. Caron In this survey, the mode of exposure seemed to influence the tolerance of PEP, but not the compliance that was equally good. |
| P86 | HIV POST-EXPOSURE PROPHYLAXIS AFTER SEXUAL ASSAULT: THE EXPERIENCE OF A SEXUAL ASSAULT SERVICE IN EAST LONDON. TO REVIEW THE UPTAKE AND OUTCOME OF POST-EXPOSURE PROPHYLAXIS AFTER SEXUAL ASSAULT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P86 AIDS 2000, Oct 22-26;14(Suppl. 4);S41 S. Limb, M. Kawsar and G.E. Forster The majority of sexual assault cases, seen in 1999, presented more than 72 h after the assault took place. Those who were offered PEP tended to embark on it, 50% completing the full 4 week course. Adverse events prevented the remainder from completing their therapy. |
| P87 | THE ITALIAN REGISTRY OF ANTIRETROVIRAL POST-EXPOSURE PROPHYLAXIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P87 AIDS 2000, Oct 22-26;14(Suppl. 4);S41 V. Puro An increasing use of PEP, has been observed, including treatments after non occupational exposure. Highly active PI containing PEP seems increasingly used as initial treatment. Efforts should be made to assure a rapid assessment of source serostatus in order to limit unnecessary PEP, and related adverse effects. Short term toxicity was frequent, mild, reversible and not unusual. |
| P88 | POST-EXPOSURE PROPHYLAXIS WITH HAART COULD NOT PROTECT MACAQUES FROM EXPERIMENTAL INFECTION WITH PATHOGENIC SHIV BUT PRESERVES FROM DECLINE OF CD4+ CELLS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P88 AIDS 2000, Oct 22-26;14(Suppl. 4);S42 R. Le Grand, B. Vaslin, K. Benlhassan, C. Bossuet, H. Thiebot, B. Delache, C. Feuillat, P. Clayette, N. Dereuddre-Bosquet and D. Dormont To conclude, starting HAART within few hours after IV exposure, as recommended for treatment of occupational exposures to blood, did not prevent from infection. Nevertheless, early transient HAART favors the installation of the immune response in the context of low CD4+ T-cell depletion which may ensure a better immune control of virus replication and retard disease progression on the long term. |
| P89 | POST EXPOSURE PROPHYLAXIS AFTER NON OCCUPATIONAL EXPOSURE TO HIV IN BUENOS AIRES, ARGENTINA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P89 AIDS 2000, Oct 22-26;14(Suppl. 4);S42 C.Wainstein, J. Benetucci, S.M. Oliva and S. Lapolla An increasing use of PEP after non occupational exposure has been observed, acceptance rate is lower than expected. Improve better patients selection and their adherence represents our next challenge. |
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2 LONG-TERM THERAPY AND ADHERENCE Abstracts P90 thru P129, Pages S42 TO S54 |
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| P90 | DURABILITY AND REASONS FOR DISCONTINUATION OF FIRST HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) IN A COHORT OF PROTEINASE INHIBITOR NAÏVE HIV-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P90 AIDS 2000, Oct 22-26;14(Suppl. 4);S42 A. Hänsel, H.C. Bucher, R. Nuesch and M. Battegay In a mixed population of HIV-infected individuals discontinuation of initial phosphate inhibitors containing HAART is high, mainly due to adverse drug reactions, drug failure and incommodity of drug regimens. |
| P91 | RELATIONSHIP BETWEEN VIRAL LOAD AND TIME WITHOUT ILLEGAL DRUGS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P91 AIDS 2000, Oct 22-26;14(Suppl. 4);S43 J. Carmena, N. Tolosa, C. Ricart, M. Jordan, M. Maciá, M.S. Monzon, M.J. Alcaraz, E. Moral and T. Orengo The duration of illegal drugs abstinence period correlates with an undetectable viral load in patients treated with HAART who have been infected through these intravenous substances. |
| P92 | ANXIETY, DEPRESSION AND IMPAIRMENT OF QUALITY OF LIFE IN HIV-INFECTED OUTPATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P92 AIDS 2000, Oct 22-26;14(Suppl. 4);S43 M. Battegay1, C. Zinkernagel1, P. Taffé2, M. Rickenbach2, R. Amiet3, B. Ledergerber4, A.C. Volkart2, U. Rauchfleisch1, A. Kiss1, V. Werder1 and P. Vernazza3, for the Swiss HIV Cohort Study Anxiety, depression and impaired quality of life are frequent in HIV-infected individuals, including those patients with an optimal response to therapy. This study highlights the importance of mental health assessment and the need for coping strategies for HIV-infected patients. |
| P93 | RESPONSE TO HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) IN TREATMENT NAÏVE HIV PATIENTS IN GLASGOW Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P93 AIDS 2000, Oct 22-26;14(Suppl. 4);S43 L.M. Short, D. Bell and R. Fox Overall, 89 antiretroviral naïve patients with a mean age of 35 years (SD 9.2) received their first HAART regimen during the study period. Median baseline CD4 lymphocyte count was 153 cells/mm3 (range 0–682) and median baseline HIV viral load was 73 000 copies/ml (range 1100– 2,100,000). Sixty-nine patients (77.5%) were CDC stage B or C. The initial regimen included a PI in 54 patients (60.7%) and a non-PI in 35 patients (39.3%). Mean follow-up since commencing treatment was 74.6 weeks (SD 48.2). Following 12 weeks of therapy 49% had an undetectable HIV viral load; 67% were undetectable after 24 weeks; 62% after 48 weeks; and 65% after 72 weeks. These results show that the majority of our treatment naïve patients achieve a sustained virological response to HAART. |
| P94 | ADHERENCE TO ANTIRETROVIRAL TREATMENT AND THERAPEUTIC OUTCOME Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P94 AIDS 2000, Oct 22-26;14(Suppl. 4);S44 M. Martini1, F. Paoletti2, A. Cargnel3, G. Carosi4, F. Mazzotta5, P. Nasta1, E. Recchia1 and V. Agnoletto1 It is showed as a correct adherence in the time (18 months) identified a major percentage of patients with a good therapeutic outcome, vice versa for low/low level. It appears that a correct/non correct level of adherence result in less success of the immunologic response, while maintain a virologic efficacy. From this result emerged strongly the importance to intervene on adherence with specific tools that could reduce patients with low/low adherence in the effort to non compromise therapeutic efficacy. |
| P95 | FACTORS DETERMINING COMPLIANCE TO HAART IN A COHORT OF 324 HIV-1-INFECTED INDIVIDUALS (CIEL BLEU STUDY) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P95 AIDS 2000, Oct 22-26;14(Suppl. 4);S44 C. Goujard1, N. Bernard2, D. Peyramond3, J. Chwallow4, D. Bertholon5 and J.-F. Delfraissy1 Preliminary results show that smoking, age, education level, income, vRNA, CD4-count, disease stage, AEs, (fatigue, nausea, abdominal pains, memory difficulties and insomnia) influence compliance with the number of treatment doses taken. |
| P96 | RANDOMISED STUDY OF A TREATMENT EDUCATION PROGRAM FOR HIV-1 INFECTED INDIVIDUALS: METHODOLOGY AND INITIAL OBSERVATIONS (CIEL BLEU STUDY) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P96 AIDS 2000, Oct 22-26;14(Suppl. 4);S44 C. Goujard1, N. Bernard2, D. Peyramond3, J. Chwallow4, D. Bertholon5 and J.-F. Delfraissy1 Preliminary observations show a trend for hospital teams expressed satisfaction with the education program. Further studies may con- firm this finding. |
| P97 | TYPE OF NON-ADHERENCE ERRORS AND RELATIVE DISTRIBUTION AMONG PATIENTS WITH HIGH, MEDIUM, LOWER LEVEL OF ADHERENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P97 AIDS 2000, Oct 22-26;14(Suppl. 4);S44 M. Martini1, F. Paoletti2, A. Libertone2, A. Cargnel3, G. Carosi4, M. Di Pietro5, P. Nasta1 and V. Agnoletto1 Adherence tends to improve, but all types of errors continues to be significantly represented. Principal errors are ‘jumping a dose’ and ‘time schedule modification’; highly reported ‘interruption of the entire combination’. It appears that patients who reported a lower level of adherence are more represented in ‘interrupt the entire combination’ and ‘modify time schedule’. This kind of error appears repeated in the time and they may be characteristic in lower level of adherence. Since the study (data not shown) identify also a reduced therapeutic outcome in patients with a lower level of adherence, this results became more important. In conclusion referring to interventions aimed to improve adherence it is suggested that identifying the type of errors committed by patients may be a valid supported to be considered. |
| P98 | PROSPECTIVE ASSESSMENT OF PHARMACOLOGICAL, VIROLOGICAL AND ADHERENCE FACTORS IN ANTIRETROVIRAL TREATMENT OUTCOME (MALIBU STUDY): ADHERENCE AND ATTITUDE TO MEDICINE SCORES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P98 AIDS 2000, Oct 22-26;14(Suppl. 4);S45 D. Pillay1, T. Jones2,4, C. Sabin3, J. Lloyd5, D. Back5, W. Verbiest 6 and E.Wilkins2 Patients failing therapy in this cohort reported a decrease in ATM score and adherence over follow-up. In the whole cohort excellent adherence was associated with a low failure rate. Efforts should be targeted at improving adherence within patients treated with HAART. |
| P99 | ANALYSING LIMITING FACTORS IN THE ACCEPTANCE OF HAART IN INJECTION DRUG USERS (IDUS) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P99 AIDS 2000, Oct 22-26;14(Suppl. 4);S45 S. Clarke, S. Delamere, F. Lyons, C. Bergin and F. Mulcahy This study highlights the chaotic lifestyle of the injecting drug user, and demonstrates several factors that limit their ability to accept HAART or adhere to HAART. Results from the complete cohort will enable specific aspects of patient care to be targeted and improved. |
| P100 | LONG TERM (104 WEEK) VIROLOGIC SUPPRESSION WITH THE TRIPLE NUCLEOSIDE HAART REGIMEN ABC/3TC/ZDV Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P100 AIDS 2000, Oct 22-26;14(Suppl. 4);S45 A. Antela (on behalf of the CNA3003 study team) ABC containing regimens, primarily ABC/3TC/ZDV, are generally well tolerated and effectively maintain durable virologic suppression for > 104 weeks. |
| P101 | DURABLE SUPPRESSION OF HIV+ RNA AFTER 2 YEARS OF THERAPY WITH ABT-378/RITONAVIR (ABT-378/R) TREATMENT IN SINGLE PROTEASE INHIBITOR EXPERIENCED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P101 AIDS 2000, Oct 22-26;14(Suppl. 4);S46 J. Feinberg1, S. Brun14, Y. Xu14, T. Marsh14, C. Benson2, S. Deeks3, H. Kessler4, R. Murphy5, R. Gulick6, D. Wheeler7, C. Hicks8, J. Eron9, P. Sax10, R. Stryker11, S. Riddler12, M. Thompson13, M. King14, K. Real14, A. Hsu14, R. Bertz14, D. Kempf14, A. Japour14 and E. Sun14, for the M97.765 Study Group ABT-378/r is well tolerated and in combination with NVP AND 2 NRTIs exhibits durable antiretroviral effect through 96 weeks in the majority of patients who have previously failed a single PI-based regimen. |
| P102 | THE DURABILITY OF VIROLOGICAL RESPONSE IN INDIVIDUALS WITH HIGH VIRAL LOAD TO NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P102 AIDS 2000, Oct 22-26;14(Suppl. 4);S46 M.R. Nelson1, M. Fisher2, A. Shaw1, G. Dean2 and B.G. Gazzard1 High viral load at baseline did not negatively affect rates or durability of viral load suppression in individuals treated with either N or E. |
| P103 | TWO-YEAR EXPERIENCE OF DUAL NRTI THERAPY FOR HIV INFECTION: ANALYSIS OF RESULTS AND FACTORS INFLUENCING VIRAL RESPONSE AND LONG-TERM EFFICACY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P103 AIDS 2000, Oct 22-26;14(Suppl. 4);S46 G. Parruti, P. Tarquini1, K. Falasca2, A. Agostinone, G. Placido, R.V. Graziani, G. D' Amico, D. Di Giammartino1, M. Dalessandro2, E. Pizzigallo2 and G. Marani Toro Dual NRTI regimens may still be an option for patients unable to adhere to more labour-intensive associations of drugs and presenting with favourable predictors of virological response. |
| P104 | SELF-REPORTED NON-ADHERENCE AT ENROLMENT IS PREDICTIVE OF FUTURE NONADHERENCE IN HIV-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P104 AIDS 2000, Oct 22-26;14(Suppl. 4);S47 R. Murri1, A. Ammassari1, K. Gallicano2, A. De Luca1, A. Cingolani1, A.W. Wu3, and A. Antinori4 In this observational cohort, self-reported non-adherence at enrolment, being less than 35 years-old, having experienced vomit or pruritus at enrolment were the strongest predictors of persistent non-adherence at follow-up. Non-adherence was not correlated to plasma HIV RNA in pre-treated populations. Interventions for adherence improvement should urgently implemented after having assessed non-adherence behaviours. |
| P105 | OPTIMISING ADHERENCE TO COMBINATION THERAPIES FOR FAMILIES WITH HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P105 AIDS 2000, Oct 22-26;14(Suppl. 4);S47 S. Head, J. White, D. Melvin for the Family HIV Team The questionnaires, flow charts, children's diaries and other tools to help adherence will be presented. |
| P106 | INITIATION OF HAART IN DRUG NAÏVE HIV-1 PATIENTS PREVENTS VIRAL BREAKTHROUGH FOR UP TO 43 MONTHS IN 60% OF THE PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P106 AIDS 2000, Oct 22-26;14(Suppl. 4);S47 A.-M. Vandamme1, K. Van Vaerenbergh1, J.C. Schmit3, B. Schmidt4, H. Walter4, E. Fontaine3, M. Schmitt2, K. Van Laethem1, A. Rascu2, V. De Vroey1, M. Grünke2, P. Löw2, M. Van Ranst1, J. Desmyter1, E. De Clercq1 and T. Harrer2 In this clinical setting, reflecting the daily practice, starting triple/ quadruple therapy in drug-naïve patients resulted in a long term sustained virologic response in 60% of the patients. Only seven of the 10 failing patients developed resistance-related mutations, often the M184V mutation. None had major resistance mutations at baseline to the initiated therapy. In this patient population, other factors such as non-compliance must have contributed to therapy failure. |
| P107 | MEDICATION BELIEFS INFLUENCE ADHERENCE TO ANTI-RETROVIRALS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P107 AIDS 2000, Oct 22-26;14(Suppl. 4);S47 M. Pugh1 and R. Horne Adherence to anti-retroviral therapy was related to the way in which individual patients balance the perceived need for treatment to maintain their health against their perceived concerns and satisfaction with the information received. Although further, larger studies are required to collaborate these findings, addressing patients perceptions about anti-retroviral therapy may provide a target for intervention. |
| P108 | HELPING BRAIN-IMPAIRED PATIENTS TAKE HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P108 AIDS 2000, Oct 22-26;14(Suppl. 4);S48 J. Meadway and S. Peddie Patients unable to take therapy because of HRBI may be rehabilitated to be independent, self-medicating and adherent to therapy. |
| P109 | ADHERENCE AND VIRAL LOAD RESPONSE TO HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P109 AIDS 2000, Oct 22-26;14(Suppl. 4);S48 B. Roca and N. Lloria Non-adherence to HAART was common. A percentage of patients achieved HIV-RNA suppression in spite of suboptimal adherence. The middle dose, scheduled for 16 h in most patients, was the most frequently missed. Forgetting to take the medications was the first reason of nonadherence. |
| P110 | OVERALL TRENDS IN CD4 COUNTS AND PLASMA VIREMIA IN A CLINICAL SETTING SINCE THE INTRODUCTION OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPIES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P110 AIDS 2000, Oct 22-26;14(Suppl. 4);S48 J.C. Martín, V. Soriano, I. Jiménez-Nácher1, P. Martínez2 and J. González-Lahoz A dramatic virological and immunological benefit has followed the introduction of HAART in HIV-infected patients since 1996. Overall, this favourable trend seems to be maintained over time, despite the negative impact of toxicity and adherence issues related to the use of multiple antiretroviral drugs. |
| P111 | DETERMINANTS OF NON-ADHERENCE IN A MULTICENTER COHORT STUDY OF PATIENTS PREVIOUSLY NAÏVE TO ANTIRETROVIRAL THERAPY (ADICONA STUDY) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P111 AIDS 2000, Oct 22-26;14(Suppl. 4);S48 A. Ammassari, R. Murri, M.P. Trotta, L. Ravasio, F. Mazzotta, P.E. Manconi, G. Carosi, S. Pauluzzi, M. Piazza, M.C. Izzo, V. Vullo, A. Scasso, F. Soscia, S. Delia, P. Caramello, E. Pizzigallo, A. Scalzini, A. Cozzi Lepri, P. Pezzotti, d'Arminio Monforte and A. Antinori for the AdICoNA Study Group. The AdICoNA Study shows that determinants of non-adherence are heterogeneous and include drug characteristics, side effects, symptoms and factors related to daily life. Physician's estimate of non-adherence results to be only poorly predictive of self-reported non-adherence. |
| P112 | PI ADHERENCE PREDICTS SHORT- AND LONG-TERM CLINICAL OUTCOME Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P112 AIDS 2000, Oct 22-26;14(Suppl. 4);S49 C.A. Donnelly, J. Hooper, N.M. Ferguson, A.C. Ghani, D. Lapins, S. Mayer and R.M. Anderson and the Swiss HIV Cohort Study not available |
| P113 | HIGH PREDICTIVE VALUE OF MEMS SUPPORTS ITS USE IN AN ADHERENCE TRATRAINING PHASE PRIOR TO THE START OF ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P113 AIDS 2000, Oct 22-26;14(Suppl. 4);S49 T. Wagels1, R. Amiet1, M. Battegay2, A.C. Guex2, M. Opravil3, P.L. Vernazza1 and the Swiss HIV Cohort Study Taking compliance measured with MEMS during initiation of HAART was highly predictive for treatment outcome. This finding prompted us to initiate a 'MEMS Training' program, where patients are trained to optimise their adherence prior to commencement of HAART. Details of the MEMStraining program will be presented together with the final results on all 60 patients of this study. |
| P114 | IMPLENTATION OF A COMPREHENSIVE HEALTH ENHANCEMENT SUPPORT SYSTEM (CHESS) FOR PEOPLE WITH HIV INFECTION: A PILOT STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P114 AIDS 2000, Oct 22-26;14(Suppl. 4);S49 Z. Temesgen, J. Knappe-Langworthy, J. Henely, M. St Marie, L. Vlasak, R. Dierkhising, A. Wright However, this needs to be verified and confirmed by studies that involve larger cohorts of patients for a longer period of time and include clinical parameters as study end-points. |
| P115 | TOWARDS AN OBJECTIVE METHOD TO EVALUATE ADHERENCE: THE CÚSPIDE STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P115 AIDS 2000, Oct 22-26;14(Suppl. 4);S49 V. Gordillo1, M. Ruiz2, J.A. Maradona3, M.J. Perez Elías4, T. Martin5, C. Miralles6, E. Cabrero7 and L. Usán7 and the CÚSPIDE Study Group This new instrument is easy to use and to correct quantitatively. It can be used so as a global measure for adherence as well as to know which factors are predictors of bad adherence in each patient. Although this measure is necessary for the clinicians, it is better than other health professionals –not the physician self– ask the questions to the patients. A longitudinal study is carried out up to M12 in order to confirm our data about differences in adherence between naïve and experienced patients. |
| P116 | MAKING CURRENT DRUG INFORMATION AVAILABLE TO PATIENTS AT A PROVINCIAL LEVEL: HOW TO MAKE IT HAPPEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P116 AIDS 2000, Oct 22-26;14(Suppl. 4);S50 R. Therrien1, A.J. Gagnon2, M. Prévost1 The provision of patient information on a large scale is facilitated by 1) the development of high quality information presented in a professional format; 2) an extensive review of the content by clinicians directly involved with patients; 3) the support and recognition by organizations at multiple levels (industry, professional, community, and patient organizations). |
| P117 | COMPACT TRIPLE NUCLEOSIDE THERAPY CAN IMPACT ADHERENCE IN THE PRISON SETTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P117 AIDS 2000, Oct 22-26;14(Suppl. 4);S50 J. Carranza Rosenzweig1, M. Fischl2, L. Kirkland3, K. Tashima4, D. Paar5, T. Gensler6, G. Capuano1 and J. Hernandez1 Overall there was a trend between patients that took their medications regularly and those that were below the detection limit of the viral load assay. The results from this study show that combivir plus abacavir is a potent and compact antiretroviral regimen that can be easily administered and adhered to in the prison setting. |
| P118 | USE OF ANTIRETROVIRAL DRUGS AND SOCIODEMOGRAPHIC FEATURES OF HIV+ PATIENTS IN A FAST TRACK SERVICE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P118 AIDS 2000, Oct 22-26;14(Suppl. 4);S50 D. Estevam, L. Jamal, C. Oliveira, R. Nunes, S. Toledo and A. Alves In the service studied, patients can be considered of a higher socioeconomic level than the general population; 22.8% of patients are still on a double regimen with two NRTI; and 82% of the patients referred a favorable self-assessment in relation to compliance. |
| P119 | DIFFERENTIAL DRUG-SPECIFIC ADHERENCE RATES AMONG HIV-POSITIVE PATIENTS IN THE CLINICAL PRACTICE SETTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P119 AIDS 2000, Oct 22-26;14(Suppl. 4);S51 J. Jordan1, S. McCallister2, D. Skiest3, C. Farthing4, C. Castro5, P. Camire5, G. Heggedus5, J. Tolson1 and G. Capuano1 The probability of perfect adherence varies widely by antiretroviral treatment, even after controlling for site, age, sex, race, and therapy duration. These findings may assist physicians and patients in their antiretroviral therapy choices. |
| P120 | PATIENT PERSPECTIVES ON POTENTIAL ADHERENCE TO TRIPLE COMBINATION ANTIRETROVIRAL REGIMENS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P120 AIDS 2000, Oct 22-26;14(Suppl. 4);S51 J. Carranza Rosenzweig1, J. Jordan1, D. Pathak2 and T. Pilon3 Patient's expected adherence varied by particular regimen. Overall, adherence was expected to be highest for TZV and lowest for NLF/ ddI/d4T. Prospective studies are required to assess if these results transfer to actual behavior, since adherence in the clinical setting is determined by the interplay of a number of factors, some of which could not be assessed in this study. |
| P121 | PERCEIVED INFLUENCE OF REGIMEN CHARACTERISTICS ON ADHERENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P121 AIDS 2000, Oct 22-26;14(Suppl. 4);S51 J. Jordan1, J. Carranza Rosenzweig1, D. Pathak2 and T. Pilon3 Of the regimen characteristics evaluated, total pills per day would be expected to have the largest impact on adherence, but dietary restrictions, dosing frequency, pill size, and combination products are also important. An optimal triple regimen would have two or less total pills per day, no dietary restrictions, all-once-a-day dosing, small pills, and all ARTs combined into one pill. The simultaneous impact of these factors, as patients encounter them in an actual HAART regimen, needs to be explored. |
| P122 | NON-ADHERENCE TO HAART: CLINICALLY RELEVANT PATIENT CATEGORISATION BASED ON ELECTRONIC EVENT MONITORING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P122 AIDS 2000, Oct 22-26;14(Suppl. 4);S51 E. Van Wijngaerden, V. De Saar, V. De Graeve, A-M. Vandamme, K. Van Vaerenbergh, H. Bobbaers, A. Deschamps, H. Ceunen and S. De Geest Using EEM monitoring and four operational definitions of adherence, we developed an algorithm that was capable to categorise two groups of adherent and non-adherent patients in our population. Despite the heterogeneity of drug regimens taken and the small group, it could be shown that these groups differed significantly in their clinical outcome, showing that the algorithmbased division is relevant and may be prognostic for long-term outcome. |
| P123 | CORRELATES OF DURABLE TREATMENT SUCCESS AMONG LONG TERM HIGHLY ACTACTIVE ANTIRETROVIRAL THERAPY (HAART). RECIPIENTS IN THE HIV OUTPATIENT STUDY (HOPS) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P123 AIDS 2000, Oct 22-26;14(Suppl. 4);S52 F. Palella, J. Chmiel, A. Moorman, C. Merry, S. Holmberg and the HOPS Investigators Abstract not reproduced at Author’s request |
| P124 | HIV INFECTED WOMEN: TREATMENT ADHERENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P124 AIDS 2000, Oct 22-26;14(Suppl. 4);S52 L. Lang, N. Nagi, M. Gertner and M. Masci The completed study analysis focuses on previously undocumented practical and emotional barriers to self-care experienced by HIV+ women. Findings suggest a lack of awareness of risk and personal neglect among respondents. Whilst these findings raise many other questions, they serve to put treatment adherence issues in a wider social and behavioural context. |
| P125 | ENTERIC COATED DIDANOSINE (EC DDI) IMPROVES TOLERABILITY BUT HAS MINIMAL IMPACT ON ADHERENCE IN A HIGHLY ADHERENT POPULATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P125 AIDS 2000, Oct 22-26;14(Suppl. 4);S53 J.C. Walsh, J. Deehan, M. Houska, M.R. Nelson and B.G. Gazzard Switching to EC ddI improved patients' attitudes to ddI and reduced their burden of symptoms. In this highly adherent population, switching to EC ddI had no overall effect on adherence. Changes in formulation may cause concern to patients stable on HAART which may have a deleterious effect on adherence. When such a switch is considered, counselling patients about potential risks and benefits is essential. |
| P126 | ADHERENCE AND BELIEFS ABOUT TREATMENT IN PATIENTS TAKING POST EXPOSURE PROPHYLACTIC ANTIRETROVIRAL THERAPY (PEP) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P126 AIDS 2000, Oct 22-26;14(Suppl. 4);S53 J.C. Walsh, N. Nwokolo, D.A. Hawkins and B.G. Gazzard Adherence to PI based PEP was equivalent to that seen in the treatment of established HIV infection. Treatment specific health beliefs of PEP patients did not differ from those of HIV positive patients taking HAART. Patients' attitudes were generally in favour of PEP but the majority harboured uncertainties about its effectiveness. |
| P127 | CAUSES OF NON-ADHERENCE TO HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P127 AIDS 2000, Oct 22-26;14(Suppl. 4);S53 B. Roca, C. Lapuebia, M.T. Edo and R. Ballester A large percentage of patients reported inadequate adherence. Forgetting to take the medications was the main reason of nonadherence. Lack of adherence is especially common among drug abusers. |
| P128 | PATIENT'S PERCEPTION OF ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P128 AIDS 2000, Oct 22-26;14(Suppl. 4);S53 R.G. Morgan, C.M. Teltscher and M. Bennie Patients could generally be divided into three groups: those who adhered rigidly to their CT and whose lifestyle revolved around it; those who adhered to CT fitting it into their lifestyle; and those who took CT when it was convenient and missed doses when it interfered with their lifestyle. |
| P129 | FACTORS AFFECTING CLINICAL TRIALS IN WOMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P129 AIDS 2000, Oct 22-26;14(Suppl. 4);S53 Rebecca Wampamba-Sebatta Women too have been treated with available therapies in HIV infection but have financial and sex hazards. |
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4.1 LIPODYSTROPHY AND METABOLIC ABNORMALITIES Abstracts P130 thru P160, Pages S54 TO S73 |
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| P130 | RISK FACTORS FOR THE HIV-ASSOCIATED LIPODYSTROPHY SYNDROME IN PATIENTS WITH UNIFORM DURATION OF ANTIRETROVIRAL TREATMENT (LIPART) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P130 AIDS 2000, Oct 22-26;14(Suppl. 4);S54 S. Mauss1, M. Corzillius2, E. Wolf3, A. Schwenk4, H. Jaeger3, H. Knechten5, J. Goelz6, A. Goetzenich7 for the LipART Network In contrast to previous reports, treatment with HIV-protease inhibitors proved not to be an independent risk immunosuppression in the pathogenesis of HIV-associated lipodystrophy syndrome. Protease-inhibitor sparing regimens appeared to be associated with a reduced risk of lipodystrophy. The lipodystrophic changes seem to affect the quality of life in the majority of patients. |
| P131 | COMPARISON OF THE PREVALENCE OF LIPODYSTROPHY IN HIV POSITIVE PATIENTS OF DIFFERENT ETHNICITY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P131 AIDS 2000, Oct 22-26;14(Suppl. 4);S54 T.A. Day and C. Rogers Variations in side effects of ART in black and white individuals are not well described. Preliminary findings of this study suggest no difference in changes in serum lipids and fat redistribution. Hopefully future findings of this ongoing study will provide more interesting results. |
| P132 | HIV+ PATIENTS WITH HAART RELATED HYPERLIPIDEMIA AND LIPID PROFILE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P132 AIDS 2000, Oct 22-26;14(Suppl. 4);S54 F. Blanco, T. García-Benayas, A. Barrios, J. de la Cruz, M.J. Senchordi, J. Sánchez, V. Soriano, J. Glez-Lahoz Both hypercholesterolemia and hypertriglyceridemia are present in more than half HIV+ subjects under HAART, being hypercholesterolemia more prevalent than hypertriglyceridemia. No differences between NNRTI and PI-based regimens were found. NNRTI+IP combination was associated with higher cholesterol and triglyceride levels than regimens containing either NNRTI or IP, This suggests a synergistic effect of these drugs on the lipid profile. |
| P133 | METABOLIC AND MORPHOLOGICAL ALTERATIONS UNDER ANTIRETROVIRAL THERAPY: PRELIMINARY RESULTS OF LIPODYSTROPHY ITALIAN MULTICENTER STUDY (LIMS) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P133 AIDS 2000, Oct 22-26;14(Suppl. 4);S54 M. Galli, F. Veglia, G. Angarano, A. Cargnel, F. Gritti, F. Mazzotta and A. Lazzarin for the Lipodystrophy Italian Multicenter Study (LIMS) In conclusion distinct MMA, observed in patients with different therapeutic history, suggest the existence of multifactorial mechanisms inducing adipose tissue alterations in ART-receiving patients. |
| P134 | ADIPOSE TISSUE ALTERATIONS AFTER STARTING ANTIRETROVIRAL THERAPY IN NAÏVE PATIENTS: THE LIPOICONA STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P134 AIDS 2000, Oct 22-26;14(Suppl. 4);S55 M. Galli, A. Cozzi-Lepri, A.L. Ridolfo, C. Gervasoni, L. Ravasio, L. Corsico, E. Gianelli, V. Vullo, A. Cargnel, L. Minoli, F. Gritti, G. Scalise, A. Antinori, G. Antinucci, A. d' Arminio Monforte, M. Moroni for the LipoICONA Study In conclusion, MoA grouped according to the Marrakech classification present different correlates of increased risk in NP, suggesting the existence of a multifactorial pathogenesis. |
| P135 | A PROSPECTIVE COHORT STUDY ON THE RISK FOR LIPODYSTROPHY IN HIV-1-INFECTED PATIENTS TREATED WITH PROTEASE INHIBITOR-CONTAINING REGIMENS. Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P135 AIDS 2000, Oct 22-26;14(Suppl. 4);S55 E. Martínez1, A. Mocroft2, M.A. García-Viejo1, J.B. Pérez-Cuevas1, J.L. Blanco1, J. Mallolas1, L. Bianchi1, I. Conget1, J.M. Gatell1 Risk factors for any LD, LD with SL, and LD with CO in HIV-1-infected patients receiving PI-containing HAART are multifactorial and overlapping, and cannot be exclusively ascribed to the duration of exposure to any particular antiretroviral agent. |
| P136 | ABNORMAL DISTRIBUTION OF FAT INCREASES WITH TIME OF EXPOSURE TO NRTIPI AND THE DEGREE OF HYPERLIPIDAEMIA IS SIMILAR IN EFAVIRENZ AND PITREATED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P136 AIDS 2000, Oct 22-26;14(Suppl. 4);S56 K. Koppel, B. Åkerlund, A. Sundstrom, L. Flamholc, G. Steineck, L. Morfeldt A correlation between ADF and total length of ART was demonstrated. Both total cholesterol and TG were significantly and equally elevated in NRTI-EFV and NRTI-PI therapy, as compared to no therapy or NRTI without EFV. In fact, the levels of TG associated with NRTI-EVF therapy were significantly higher than in the other groups with antiretroviral therapy. |
| P137A | ASSOCIATION BETWEEN LIPODYSTROPHY AND METABOLIC DISORDERS IN HIVINFECTED PATIENTS TREATED BY PROTEASE INHIBITORS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P137 AIDS 2000, Oct 22-26;14(Suppl. 4);S56 F. Raffi1, M. Savs2, A. Basdevant3, G. Le Moal4, J. Capeau5, J.M. Estavoyer6, G. Chne2, C. Leport7, W. Rozenbaum8 and APROCO (ANRS EP11) Study Group Frequency of isolated biological disorders only differed according to age. Association of clinical and biological disorders was more frequent in patients with higher age (P < 10.3), higher BMI (P = 0.004), but not longer duration on PI (P = 0.36). Early detection and specific management of metabolic disorders should especially be implemented in older patients and in those with higher BMI. |
| P137B | LIPODYSTROPHY IN PATIENTS WITH HIV-1 INFECTION: EFFECT OF STOPPING PROTEASE INHIBITORS ON TNF-RECEPTOR LEVELS, INSULIN RESISTANCE, AND LIPID PROFILE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P137 AIDS 2000, Oct 22-26;14(Suppl. 4);S56 B. Maher1, J. Lloyd1, E.G.L. Wilkins3, W.D. Fraser2, D.J. Back1, B.K. Park1 and M. Pirmohamed1 Our results show a reversal in some but not all of the abnormalities associated with LD on stopping PIs. TNF-a activity may be modulated by PIs and may be responsible for some of the features of LD. Our results are also consistent with the hypothesis that many of the features of LD are due to an interaction between the disease and drug therapy rather than being an effect of PIs per se. |
| P138 | INTERFERON-β THERAPY INCREASES PLASMA TRIGLYCERIDE CONCENTRATIONS IN HIV-1 SEROPOSITIVE PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P138 AIDS 2000, Oct 22-26;14(Suppl. 4);S56 J.F. Morlese, N.A. Qazi, D. Asboe, B.G. Gazzard and M.R. Nelson Plasma triglyceride concentrations are increased in HIV-1 seropositive patients treated with exogenous interferon-a therapy. This evidence supports the hypothesis that increased cytokine concentrations may play a role in the development of dyslipidaemia and lipodystrophy in HIV infected patients treated with HAART. |
| P139 | MALE BREAST ENLARGEMENT FOLLOWING SUCCESSFUL HAART: A POSSIBLE IMMUNE RESTORATION PHENOMENON? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P139 AIDS 2000, Oct 22-26;14(Suppl. 4);S56 N.A. Qazi, J.F. Morlese, D.M. King, B.G. Gazzard and M.R. Nelson Our study is the first to show that gynaecomastia can occur with all classes of antiretrovirals and that it is indeed due to glandular proliferation and not subcutaneous fat deposition. All the patients developed symptoms of breast enlargement rapidly and all were on a successful regimen. Of the patients originally identified more than 75% (12/15) have had complete resolution of their symptoms without any intervention 6 months after diagnosis. In the absence of any other obvious mechanism we postulate that gynaecomastia may be a result of increased cytokine activity. Cytokines may be involved in up-regulation of cell oestrogen receptors, or, may directly stimulate the oestrogen receptor causing gynaecomastia. Immune restoration as a unifying mechanism in our patients may also explain why gynaecomastia occurs with all classes of antiretrovirals and why it resolves in the majority of cases without intervention. |
| P140 | GYNECOMASTIA DURING LONG-TERM ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P140 AIDS 2000, Oct 22-26;14(Suppl. 4);S57 A. Mastroianni, C. Cancellieri and F. Allegrini We suggest that gynecomastia should be included among the potential adverse effects of long-term antiretroviral therapy, not restricted to the use of HAART regimens containing a PI. In some cases discontinuing a PI or the substitution with an NNRTI or with one other PI can ameliorate the breast enlargement. Large studies and long-term follow-up are necessary to determine the epidemiologic and pathogenic implications of gynecomastia and the use of antiretroviral therapies. |
| P141 | SUBSTITUTION OF ZIDOVUDINE (AZT) FOR STAVUDINE (D4T) IN A REGIMEN WITH LAMIVUDINE (3TC) AND EFAVIRENZ (EFV) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P141 AIDS 2000, Oct 22-26;14(Suppl. 4);S57 H. Knechten, K.H. Stürner, C. Höhn and P. Braun The analysed data indicate that a switch from D4T to AZT is a good opportunity for patients with successful long-term ART. |
| P142 | LIPID PROFILE AND LIPODYSTROPHIC BODY SHAPE CHANGES IN HIV+ PATIENTS AFTER SWITCHING FROM PI TO NNRTI Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P142 AIDS 2000, Oct 22-26;14(Suppl. 4);S57 T. García-Benayas, C. Casimiro, G. Gómez, J. de la Cruz, P. Barreiro, F. Blanco, V. Soriano and J. Glez-Lahoz In a significant proportion of patients previously treated with PI, SP strategies (PI→NNRTI) improve LD morphologic alterations and seem to be virologically and immunologically safe. The lipid profile remained unchanged so other lowering lipid interventions must be considered. |
| P143 | MENTAL DISORDERS RELATED TO LIPODYSTROPHIC BODY SHAPE CHANGES IN HIV+ PATIENTS WITH HOMOSEXUAL RISK BEHAVIOR Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P143 AIDS 2000, Oct 22-26;14(Suppl. 4);S58 L. Gallego, F. Blanco, V. Gordillo, J. de la Cruz, T. García-Benayas, E. Castillo, P. López and J. Glez-Lahoz Mental disorders in homosexual HIV+ men with antiretroviral treatmentrelated lipodystrophy tend to be more frequent than in those subjects without body-shape changes. Affective disturbances are the most prevalent. Multidisciplinary approach with mental health providers is warranted in these patients. |
| P144 | HIV+ PATIENTS UNDER ANTIRETROVIRAL TREATMENT AND LACTATE LEVELS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P144 AIDS 2000, Oct 22-26;14(Suppl. 4);S58 T. García-Benayas, F. Blanco, F. Laguna, V. Soriano, V. Moreno, E. Valencia, M.J. Senchordi and J. Glez-Lahoz Hyperlactatemia develops in some HIV+ patients under antiretroviral treatment. Male gender, homosexual behavior, time on HAART, hyperlipemia and morphological LD changes are all conditions associated with high lactate levels in an univariate analysis. |
| P145 | LACTIC ACIDOSIS DURING HAART: REPORT OF 6 CASES IN A PERUVIAN HOSPITAL Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P145 AIDS 2000, Oct 22-26;14(Suppl. 4);S58 R. Salazar, L. Gutierrez, R. Illescas, J. Villena, C. Sotelo, A. Irey, J. Vega, L. Rodriguez and R. Castillo This complication is rare but potentially fatal. It requires an early diagnosis and the treatment includes suspension of the antiretroviral treatment. It must be emphasized that patients receiving stavudine, zidovudine, lamivudine and/ or didanosine have to be carefully monitored to detect precociously any metabolic abnormality. |
| P146 | A CASE MANAGEMENT APPROACH FOR TWO DIABETIC PATIENTS RECEIVING HAART AND RECOMBINANT HUMAN GROWTH HORMONE (SEROSTIMTM) (GH) FOR HIV-ASSOCIATED WASTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P146 AIDS 2000, Oct 22-26;14(Suppl. 4);S58 M. Scheperle1, P. Dinguss1, R. Schwalbert2 and R. Pettit2 This report would suggest that the use of GH in diabetic patients with HIV associated wasting is manageable given proper monitoring of glucose levels and adequate amounts of daily insulin. Previous data reports have shown that GH may have a negative effect on normal glucose levels. |
| P147 | MAMMALIAN CELL-DERIVED RECOMBINANT HUMAN GROWTH HORMONE (RHGH[M]) IMPARTS A DURABLE AND REPRODUCIBLE EFFECT ON BODY WEIGHT IN PATIENTS WITH AIDS WASTING (AW) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P147 AIDS 2000, Oct 22-26;14(Suppl. 4);S58 P.M. Nemechek1, H. Landy2 and P. Gaccione2 Nearly 70% of the improvement in body weight was maintained during an average of about 2 months off therapy. A subsequent course of therapy resulted in a gain in body weight similar in magnitude to the weight gain during the initial 12-week period of treatment. These data suggest that at the conclusion of a 12-week course of r-hGH[m] for AW, patients can be monitored with monthly determinations of body weight and body composition and additional courses of therapy may be instituted without loss of efficacy. |
| P148 | THE USE OF RECOMBINANT GROWTH HORMONE IN PATIENTS WITH ABDOMINAL FAT ACCUMULATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P148 AIDS 2000, Oct 22-26;14(Suppl. 4);S59 M Gorensek1 and T. Strawbridge2 r-hGH[m] is effective in the treatment of AIDS wasting and has shown effectiveness in reducing abdominal fat accumulation. The durability of r-hGH[m] in maintaining these effects is unknown. Further studies are needed to evaluate the long-term effects of r-hGH [m] in patients diagnosed with HARS. |
| P149 | PROSPECTIVE MEASUREMENT OF BODY COMPOSITION CHANGES IN PATIENTS RECEIVING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P149 AIDS 2000, Oct 22-26;14(Suppl. 4);S59 A.B. Morris1, S. CornieleT2, D. Gordon1, S. Weber-Vincins3 and A. Baaj3 Abstract not reproduced at Author’s request |
| P150 | DIFFERENT FACTORS ARE ASSOCIATED WITH LIPOHYPERTROPHY AND LIPOATROPHY IN HIV PATIENTS WITH FAT MALDISTRIBUTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P150 AIDS 2000, Oct 22-26;14(Suppl. 4);S59 N. Muurahainen, M. Glesby, J. Falutz, M. Kleintop, J. Balser, R. Pettit and the SALSA Investigators Group In conclusion, separate sets of factors are associated with abnormal FA (gender, high BMI, viral suppression) and abnormal FD (d4T, low BMI). Additional research is recommended to ascertain whether lipohypertrophy (FA) comprises a syndrome which is separate and different from lipodystrophy (lipoatrophy or FD). |
| P151 | GAINS IN LEAN BODY MASS (LBM) AND NOT BODY FAT ARE ASSOCIATED WITH IMPROVED SURVIVAL IN PATIENTS WITH AIDS WASTING (AW) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P151 AIDS 2000, Oct 22-26;14(Suppl. 4);S60 E. Daar1, P. Gaccione2, N. Muurahainen2, D.P. Kotler3 and H. Landy2 Changes in body weight or LBM correlated strongly with improved survival, independent of all baseline parameters (adj. P < 0.001 and P = 0.005, respectively) while changes in body fat did not (adj. P = 0.79). A 1% increase in LBM was associated with an estimated 6.7% decrease in mortality [95% CI (2%, 11%)]. As the mean increase in LBM was 5%, the estimated overall improvement in survival was ~34%. While cause and effect cannot be established from this retrospective analysis, restoration of weight in patients with AW is associated with improved survival, physical performance and quality of life. This association appears to be mediated by gains in LBM, not fat, and is independent of CD4 cell count and VL. |
| P152 | EFFECTS OF OXANDROLONE ON BODY WEIGHT AND COMPOSITION IN PATIENTS WITH AIDS WASTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P152 AIDS 2000, Oct 22-26;14(Suppl. 4);S60 D. Butcher1, T. Faith1, D. Thompson1, D. Lapins2 and E. Hamel2 The wasting syndrome is still prevalent in HIV patients, even in the era of HAART. In this cohort, treatment with oxandrolone did not result in an increase in body weight nor in body composition parameters, like BCM. Until benefit is proven in a randomized trial with controlled settings, administration of oxandrolone should be cautiously considered for AWS patients. |
| P153 | LIPID METABOLISM ABNORMALITIES IN PROTEASE INHIBITORS-TREATED HIV-INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P153 AIDS 2000, Oct 22-26;14(Suppl. 4);S60 E. Pontali, L. Papa, P. Fiore1, N. Bobbio, M. Bassetti, B. Bucci and D. Bassetti Increase of lipid blood levels was very frequent (44.4% of considered children) and worrying because of possible long-term cardiovascular consequences. So, intervention strategies are necessary and they are currently under investigation at our institution. The observed frequency of abnormal fat distribution (19.4% of treated children) poses greater questions about its reversibility and its interaction with normal growth of children. |
| P154 | MINIMAL EFFECT OF AZT, DDI, DDC AND 3TC NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS OR LATE STAGE DISEASE ON DYSLIPIDAEMIA IN HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P154 AIDS 2000, Oct 22-26;14(Suppl. 4);S61 J. Thaventhiran, L. Riddel, J. Anderson, A. Pinching and J. Parkin These results suggest that the hypercholesterolaemia seen in patients on combination treatment regimens cannot be attributed to late stage HIV disease. The result that the 'off' treatment group had a lower total cholesterol than the 'on' treatment group, but with both groups having a mean well below the upper limit of normal, suggests that the older NRTIs (AZT, DDI, DDC and 3TC) only have a minor role in the dyslipidaemia seen in patients on combination therapy. Analysis of the data from the current patients on 'newer' NRTIs, NNRTIs and PI-containing regimes will be presented. |
| P155 | PREVALENCE OF LIPODYSTROPHY AND METABOLIC COMPLICATIONS IN HIV-TREATED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P155 AIDS 2000, Oct 22-26;14(Suppl. 4);S61 C. Sánchez-Luis, I. Santos, J.M. Casado, M.C. Martinez, J. Sanz Lipodystrophy and metabolic complications are frequently observed in our HIV-treated patients population. |
| P156 | EVALUATION OF ATORVASTATIN AND PHARMACY-BASED INTERVENTIONS FOR THE MANAGEMENT OF HYPERTRIGLYCERIDEMIA IN HIV-1 INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P156 AIDS 2000, Oct 22-26;14(Suppl. 4);S61 J.R. Villano, K.K. Graham, M. Sension, S. Sharma, J. Joseph and L. Ter Reit Patients achieved the goal TG levels; however, the time to reach efficacy was greater than usual, which may be because atorvastatin was not titrated in a timely manner. Pharmacists were able to make positive interventions to help better manage patients with HTG. |
| P157 | INTIMA–MEDIA THICKNESS MEASURES IN HIV-1 INFECTED PATIENTS WITH HAART, LIPODYSTROPHY AND METABOLIC DISORDERS: THE SUPRA STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P157 AIDS 2000, Oct 22-26;14(Suppl. 4);S61 P. Mercié, R. Thiébaut, V. Lavignolle, J.L. Pellegrin, M.C. Vives, P. Morlat, G. Chne, J.M. Ragnaud, M. Dupon, D. Malvy, R. Roudaut, F. Dabis and the GECSA (Groupe d’ Epidémiologie Clinique Du Sida en Aquitaine) Cardiovascular risk factors found in HIV patients are identical to those identified in general population. In this early report we indicate that IMT increased in HIV patients with LD, but no independent link is shown between increased IMT, LD clinical signs and HAART. |
| P158 | CARDIOVASCULAR RISK ASSESSMENT IN HIV POSITIVE PATIENTS IN GLASGOW Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P158 AIDS 2000, Oct 22-26;14(Suppl. 4);S62 N. Bodasing, D.J. Bell, R.A. Seaton, D. Kennedy and R. Fox To date 56 patients (41 male) have been assessed. Nineteen were protease inhibitor (PI) experienced. Median risk in HIV-infected patients was 3% (range 0–58%) compared with 2% (range 0–13%) in controls (P = 0.045). Patients who were PI experienced had a median risk 4.5% (range 0–58%) compared with 2% (range 0–24%) in those who were PI naïve (P = 0.045). Using this risk model patients with HIV infection are more likely that the general population to suffer a coronary event over the next 10 years. Risk is greater in patients exposed to PIs but also increased in patients who are PI naïve. Cardiovascular risk should be assessed in all patients with HIV infection and high risk patients should be targeted for risk reduction (e.g. smoking cessation, antihypertensive therapy and lipid lowering therapy. The role of this model in determining the choice of antiretroviral therapy needs to be considered. |
| P159 | MYOCARDIAL INFARCTION AND PROTEASE INHIBITOR THERAPY: TWO CASE REPORTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P159 AIDS 2000, Oct 22-26;14(Suppl. 4);S62 S. Curran, S. Clarke, C. Forkin, C. Bergin, F. Mulcahy For patients who are receiving PI therapy with additional coronary risk factors, they should be assessed regularly using a recognised cardiovascular assessment scale as recommended by the Adult ACTG Cardiovascular Disease Focus Group [2]. Appropriate interventions such as dietary changes, lipid lowering agents, anti-platelet agents, can then be implemented. |
| P160 | IS HYPERLIPIDEMIA THE ONLY CARDIOVASCULAR RISK FACTOR THAT NORMALISES WHEN DISCONTINUING PROTEASE INHIBITORS? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P160 AIDS 2000, Oct 22-26;14(Suppl. 4);S62 K. Koppel, G. Bratt, B. Lund, E.-L. Fredriksson and E. Sandström In the group continuing PI-HAART, glucose, Lp(a) and fibrinogen levels continued to increase during the 12 months observation time. The weight decreased, possibly due to subcutaneous fat loss. However, after stopping PI only cholesterol and LDL-C tended to normalise. Thus the plasma hypercholesterolemia, i.e. the increased cholesterol and LDL-cholesterol, seem to be reversible when discontinuing PI treatment whereas the increased levels of Lp(a), insulin, PAI-1 and fbg might persist. |
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4.2 HEPATOTOXICITY Abstracts P161 thru P165, Pages S63 TO S64 |
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| P161 | ASSESSMENT OF HEPATIC CYTOLYSIS IN PATIENTS SWITCHED FROM A PROTEASE INHIBITOR (PI)-CONTAINING REGIMEN TO A NON NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI)-CONTAINING REGIMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P161 AIDS 2000, Oct 22-26;14(Suppl. 4);S63 B. Bonnet, J.L. Esnault, V. Reliquet, E. Billaud, C. Francois, C. Allavena, B. Milpied, P. Perre and F. Raffi Incidence of transaminases elevation > 5N after PI–NNRTI switch was 10% (4/41) during the first year of follow-up. Intercurrent acute or chronic viral hepatitis was present in 3/4 patients. Moderate transaminases elevation was present at the time of PI–NNRTI switch in 22% of patients, 80% of whom having a co-infection with HBV or HCV. The low incidence of hepatotoxicity (transaminitis > 5N) related to NNRTI might be due to respect of the lead-in dose of nevirapine and/or good immunovirological parameters of the patient population. |
| P162 | NEVIRAPINE AND LIVER HEPATOTOXICITY: RELEVANCE IN CLINICAL PRACTICE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P162 AIDS 2000, Oct 22-26;14(Suppl. 4);S63 C. Font, R. Guitart, A. Sóler, M. Vila, P. Mas, C. Villà and E. Pedrol Severe liver toxicity leading to discontinuation of NVP therapy was observed in 8.9% of cases. Asymptomatic, mild to moderate increase of liver enzymes is common (44.7%) in patients receiving NVP and its longterm significance remains unknown . Patients with underlying liver viral disease have not increased risk for developing liver toxicity. |
| P163 | LIVER TOXICITY AFTER THE INTRODUCTION OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P163 AIDS 2000, Oct 22-26;14(Suppl. 4);S63 R. Lana, J.L. Mendoza, M. Núñez, V. Soriano and J. González-Lahoz Liver toxicity occurred in about 1/3 of patients after initiating HAART, very often mild and transient. There were no differences in incidence or severity when subjects receiving PI were compared to those on NNRTI. |
| P164 | HEPATOTOXICITY OF NON NUCLEOSIDE ANALOGUES: NEVIRAPINE VERSUS EFAVIRENZ Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P164 AIDS 2000, Oct 22-26;14(Suppl. 4);S63 L. Martin-Carbonero, R. Rodríguez-Rosado, V. Soriano and J. González-Lahoz Severe hepatotoxicity was seen in 13.7% of patients who began NNRTI (20/150). Cholestasis accounted for more than 2/3 of cases and was more often related to NVP. Cytolysis grade 3 or 4 was seen in 4.72% of patients (7/ 148) which was half of that seen for PI. |
| P165 | EFFICACY AND TOLERANCE OF NEVIRAPINE IN CLINICAL PRACTICE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P165 AIDS 2000, Oct 22-26;14(Suppl. 4);S64 M.J. Tellez1, B. Diaz1, C. Fernandez2, V. Estrada1, V. Roca1 and A. Fernandez-Cruz1 Nevirapine is an effective antiretroviral therapy, mainly for naïve patients, achieving good levels of VL and CD4. It is well tolerated, and the rate of adverse effects is low. GGT may be a marker of hepatic toxicity, very important for hepatitis C virus coinfected patients and in who have received previous treatment. |
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4.3 OTHER ADVERSE EVENTS Abstracts P166 thru P198, Pages S64 TO S73 |
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| P166 | THE HIVBIVUS PROJECT - A CONCEPT FOR THE SURVEILLANCE OF ADVERSE DRUG REACTIONS IN HIV-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P166 AIDS 2000, Oct 22-26;14(Suppl. 4);S64 L. Morfeldt, B. Åkerlund, K. Koppel, B.E. Wiholm, L. Flamholc, G. Steineck and Ö. Mortimer A well functioning organisation for the intensified ADRsurveillance has been established within the HivBivus Project. The protocol developed was successful and patients self-reporting proved to be a useful tool in the surveillance of adverse drug reactions. |
| P167 | CLINICIANS' ATTITUDES TO REPORTING ADVERSE DRUG REACTIONS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P167 AIDS 2000, Oct 22-26;14(Suppl. 4);S65 F. Tyrer, A. Breckenridge, M. Pirmohamed, A. Babiker, M. Hooker, A.M. Swart, P. Kelleher and J. Darbyshire A high proportion of clinicians caring for HIV infected individuals have reported ADRs to the CSM and compared to results from a similar survey [1], where only 54.7% of specialists had ever reported an ADR, HIV specialists appear to be motivated to report. The blue card scheme was set up because of concerns over previous low reporting of adverse reactions, believed to be due to issues of confidentiality, however this does not appear to be an issue. ADR reporting is particularly important in HIV infection as drugs are licensed with relatively few individuals exposed and for relatively short periods of time. From the results of this survey it is clear that doctors should continue to be informed about the scheme and about reporting guidelines. |
| P168 | ABACAVIR INDUCED HYPERSENSITIVITY IN HIV INFECTED INDIVIDUALS IS ASSOCIATED WITH AN INCREASED FREQUENCY OF TH0 T CELLS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P168 AIDS 2000, Oct 22-26;14(Suppl. 4);S65 A. Vyakarnam1, D. King1, M. Boaz1, A. Waters1, P. Easterbrook1, D. Thorborn2, L. Thurmond3 and D. Kemeny1 Patients with disease had higher frequencies of spontaneous IL4+ T cells compared to naïve controls. However, hypersensitive patients had signifi- cantly higher numbers of CD4 and CD8 T cells that were stimulated to produce IL4 than progressors. This reflected a significant decrease in IL4+ T cell numbers in progressors, and a trend for higher IL4+ cells in the CD4 compartment in hypersensitives compared to naïve controls. This trend for higher CD4+ IL4-+ cells in hypersensitives was due to a significant expansion of Th0 cells and a trend for increased frequencies of Th2 cells, in comparison to naïve controls. Hypersensitive patients did not lose IFN-γ+ T cells significantly compared to progressors, controls, or treatment stable patients. Expansion of IFN-γ+ CD8 T cells was a striking feature of only LTNPs. Our observations demonstrate a significant expansion of Th0s associated with hypersensitivity to abacavir. The characterisation of IL4/IFN-γ single and double positive T cells for chemoattractant and pro-inflammatory mediators will help to clarify their role in abacavir hypersensitivity. |
| P169 | HIV RELATED PERIPHERAL NEUROPATHY TREATED WITH GABAPENTIN IN GLASGOW Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P169 AIDS 2000, Oct 22-26;14(Suppl. 4);S65 N. Bodasing, S.C. Eves, R. Fox, D. Kennedy and R.A. Seaton In our patient cohort gabapentin at a daily dose of 0.9–1.8 g is effective in the symptomatic treatment of HIV-related peripheral neuropathy when CD4 counts are > 200/cmm. Our findings support the suggestion that higher doses may be necessary in advanced HIV disease (CD4 < 200/cmm) [4] |
| P170 | ROLE OF NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS IN CAUSING ADVERSE EVENTS IN THE HAART-TREATED POPULATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P170 AIDS 2000, Oct 22-26;14(Suppl. 4);S65 P. Bonfanti, E. Ricci1, I. Faggion, L. Valsecchi, S. Carradori, L. Pusterla, P. Fortuna, L. Timillero, F. Alessi, G. Ghiselli, A. Gabbuti, C. Martinelli, F. Parazzini1, S. Landonio and T. Quirino Didanosine and stavudine are the NRTIs that most frequently generate adverse events in the HAART-treated population while AZT is the best tolerated drug. If we consider NRTI combination, AZT/ddI and d4T/ddI have the higher incidence rate of severe adverse reaction while AZT/ddC has the lower. |
| P171 | TOLERABILITY OF EFAVIRENZ (EFV) BASED REGIMEN: A CANADIAN HIV CLINIC EXPERIENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P171 AIDS 2000, Oct 22-26;14(Suppl. 4);S66 J.G. Baril, D. Tessier, M.A. Bélanger, P. Côté, S. Dufresne, P. Junod and F. Laplante Therefore, in our clinic's experience, EFV was relatively well tolerated. The most common adverse event causing discontinuation was CNS symptoms. In addition, EFV was able to achieve and maintain viral load suppression over a mean of 51 weeks in approximately half of the treatmentexperienced patients. |
| P172 | URINARY PROBLEMS ASSOCIATED WITH PROTEASE INHIBITOR TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P172 AIDS 2000, Oct 22-26;14(Suppl. 4);S66 R. Colebunders, W. Schrooten, R. Finazzi, J. Kosmidis, A. De Roo and C. Dreezen, on behalf of the Eurosupport II Group Urinary problems occur frequently in patients on indinavir and to a lesser extent in patients on nelfinavir. Urinary problems could also be associated with ritonavir. |
| P173 | GASTROINTESTINAL COMPLAINTS DURING ANTIRETROVIRAL TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P173 AIDS 2000, Oct 22-26;14(Suppl. 4);S66 C. Dreezen, W. Schrooten, A. Castro, F. Antunes, J. Pelgrom, and R. Colebunders, on behalf of the Eurosupport Group Patients on a PI treatment regimen suffer more often from gastrointestinal side effects than patients on a non-PI regimen. |
| P174 | ADVERSE REACTIONS ASSOCIATED WITH USE OF MEDICATIONS IN HIV-INFECTED PREGNANT WOMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P174 AIDS 2000, Oct 22-26;14(Suppl. 4);S66 S.Widdecombe, J. Slattery and M.M.T. Hudson Three areas have been identified for further investigation; 'premature delivery', and the birth 'defects cardiovascular disorders' and 'renal and urinary disorders'. Databases of spontaneous reports can supplement information from pre-clinical and clinical studies and the International Antiretroviral Pregnancy Registry in the assessment of the possible risks of use of medication in pregnancy in HIV-infected women. |
| P175 | COCAINE-INDUCED THROMBOCYTOPENIA IN A YOUNG HIV SEROPOSITIVE INJECTING DRUG USER Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P175 AIDS 2000, Oct 22-26;14(Suppl. 4);S67 C. McMahon, S. Clarke, S. Gaynor, E. McGrath, F. Mulcahy and C. Bergin This case illustrates that while there are numerous causes of thrombocytopenia in HIV positive patients, cocaine induced thrombocytopenia must be considered a possibility in drug misusers. This appears to be immune mediated with a rapid and consistent response to immune globulin. |
| P176 | SEVERE CUTANEOUS ULCERATION SECONDARY TO CMV INCLUSION DISEASE IN A PATIENT DURING SUCCESSFUL IMMUNE RESTORATION WITH HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P176 AIDS 2000, Oct 22-26;14(Suppl. 4);S67 N.A. Qazi, J.C. Walsh, C.B. Bunker, N. Francis, B.G. Gazzard and M.R. Nelson Cutaneous ulceration has been described with CMV but never to this extent. We hypothesise that following HAART there was partial restoration of immunity to CMV leading to a heightened inflammatory response without being able to dear the infection leading to inflammation of the skin vascular endothelium with attendant skin ulceration and necrosis. |
| P177 | ERYTHRODYSETHESIA FOLLOWING DOXORUBICIN THERAPY FOR KAPOSI'S SARCOMA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P177 AIDS 2000, Oct 22-26;14(Suppl. 4);S67 L. Fay, S. Clark, P. Harrington, F. Mulcahy and C. Bergin Further treatment with liposomal doxorubicin was withheld and he was treated symptomatically with analgesics and emollients. Since then there has been no further progression of his KS, and he continues to remain virally suppressed on HAART. Studies suggest that this alone will be beneficial for his KS [3]. |
| P178 | CHILD PROTECTION ISSUES AROUND STARTING EFAVIRENZ IN A MOTHER ON MAINTENANCE METHADONE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P178 AIDS 2000, Oct 22-26;14(Suppl. 4);S68 J. Meadway Had this patient started efavirenz at home unsupervised, her child could have been injured. This appeared to be due to the neurological effects of efavirenz rather than opiate withdrawal. Caution should be exercised on starting efavirenz in mothers who care for small children. |
| P179 | IMMUNE RECOVERY INFLAMMATORY SYNDROME IN PERSONS WITH HIV FROM SOUTH INDIA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P179 AIDS 2000, Oct 22-26;14(Suppl. 4);S68 N. Kumarasamy, J. Biswas, Purnima Madhivanan, Tokugha Yepthomi, C. Venkatesan and Suniti Solomon In developing countries like India where many of the individuals receiving antiretroviral therapy also have multiple opportunistic infections. Immune recovery inflammatory disorders can also harm these individuals. Hence close clinical monitoring is needed on those receiving antiretroviral therapy. |
| P180 | THE ADVERSE EVENTS OF ANTIRETROVIRAL THERAPY (ARVRX) AS A CAUSE OF HOSPITALISATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P180 AIDS 2000, Oct 22-26;14(Suppl. 4);S68 D. Latarska, R. Podlasin, J. Gizi Dska, P. Grabczewski, K. Koch, E. Pastuszka. I. Wierzchowska and B. Sawicka In 30 cases adverse events were the main and exclusive cause of admission. The mean time of hospitalisation was 11.1 days (range 3–71 days). The shortest time of hospitalisation was required for patients with kidney stones (from 3 to 5 days), In nine patients adverse events were life-threatening: in 2/5 cases of hepatitis liver failure was diagnosed, a case of pancreatitis was surgically treated; in one case of anaemia the haemoglobin was as low as 1.9 g/dl; all patients with allergic dermatitis were diagnosed as Stevens–Johnson syndrome. The widespread use of ARV drugs increases the risk of severe adverse events. |
| P181 | DRONABINOL REDUCES ANTIRETROVIRAL (ARV)-ASSOCIATED NAUSEA AND VOMVOMITING (N/V) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P181 AIDS 2000, Oct 22-26;14(Suppl. 4);S68 R. Anderson, D.B. Ferriman, J.C. Street and L. Pennelly The two different dronabinol dosing schedules demonstrated a significant reduction in N/V in patients taking ARV drugs. These data suggest that dronabinol can be used to effectively manage N/V associated with ARV medications. Further studies are necessary to address this question in more detail. |
| P182 | GENDER, USE OF CORTICOSTEROIDS AND CD4 COUNTS ARE PREDICTIVE FACTORS OF NEVIRAPINE-ASSOCIATED RASH Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P182 AIDS 2000, Oct 22-26;14(Suppl. 4);S69 A. De Luca1, A. Baracchini2, F. Baldini1, M. Zaccarelli2, A. Cingolani1, P. De Longis2, S. Di Giambenedetto1, V. Tozzi2, M.G. Rizzo1, R. Murri1, G. Ippolito2, A. Ammassari1 and A. Antinori2 Female HIV+ patients, those taking steroid prophylaxis and those with higher CD4 counts have increased risk of developing NVP-associated CHR, while initial NVP escalating dose reduces the risk of CHR. |
| P183 | TOLERABILITY OF ABACAVIR IN THE CLINICAL SETTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P183 AIDS 2000, Oct 22-26;14(Suppl. 4);S69 L. Martín-Carbonero, R. Rodríguez-Rosado, P. Barreiro, V. Soriano and J. González-Lahoz In conclusion, in a clinical setting, ABC looks relatively safe. Overall, 4% of subjects developed hypersensitivity, always resolved when the drug was discontinued. However, the total rate of discontinuation was 8%, which is slightly higher than that reported in original clinical trials. |
| P184 | THE RATE OF HYPERSENSITIVITY REACTIONS TO ABACAVIR IS SIMILAR IN UNDERREPRESENTED POPULATIONS AND INCARCERATED SUBJECTS (GW PROTOCOLS NZTA4002, 4005, 4006, 4007) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P184 AIDS 2000, Oct 22-26;14(Suppl. 4);S69 J. Hernandez, V.Williams, M. Shaefer, D. Goodwin, A. Pierce, J. Snidow and N. Graham ABC is safe and well tolerated in under-represented populations and incarcerated individuals. The rate of HSR to ABC in these populations is no different from that seen in previously reported clinical trials. Additional analysis of risk factors is warranted. |
| P185 | HYPERSENSITIVITY REACTION TO ABACAVIR (ABC): AN ATYPICAL PRESENTATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P185 AIDS 2000, Oct 22-26;14(Suppl. 4);S69 K. Kabeya, Y. Van Laethem, M. Poncin and N. Clumeck Hypersensitivity reaction to ABC is typically associated with systemic symptoms and the cutaneous involvement, when present, is usually diffuse. To our knowledge, this is the first case of palmo-plantar erythema multiforme reported, without any systemic reaction, with the use of this drug. With a more extensive use of ABC, the real nature and frequency of allergic reactions will be better characterised. |
| P186 | AVASCULAR NECROSIS (AVN) IN HIV-INFECTED PATIENT TREATED WITH HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P186 AIDS 2000, Oct 22-26;14(Suppl. 4);S70 M. Gérard, D. Hardy, S. De Wit, Y. Van Laethem and N. Clumeck AVN was diagnosed in our centre only after PI were introduced. None of the five cases had clinical manifestations of lipodystrophy, and only one had elevated Tg level suggesting that the physiopathology of AVN could be different from other complications due to antiretroviral agents. Proteic deposits in bone need to be confirmed by other pathological studies. Delay in diagnosis was frequent. Clinicians must be aware of this rare but devastating complication of HAART that could benefit from switching to PI sparing regimen. |
| P187 | BILATERAL OSTEONECROSIS OF FEMORAL HEADS IN AN AIDS PATIENT ON HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P187 AIDS 2000, Oct 22-26;14(Suppl. 4);S70 P. Löw1, L. Schneider2, N. Blank1, J.R. Kalden1 and T. Harrer1 Aseptic osteonecrosis of the femoral heads was diagnosed in an advanced AIDS patient. Multifactorial risk factors were coinfection with CMV and HIV and prolonged antiretroviral therapy including all protease inhibitors available at that time. Hip replacement is a feasible treatment option even in advanced AIDS patients to regain full mobility and quality of life. |
| P188 | SEVERE ADVERSE EVENTS IN PATIENTS RECEIVING RIFABUTIN LOW DOSE AND RITONAVIR BABY DOSE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P188 AIDS 2000, Oct 22-26;14(Suppl. 4);S70 D. Konopnicki, M. Gérard, S. De Wit and N. Clumeck When used in combination with RTV/IDV 100/800 mg bid, RB 150 mg daily was poorly tolerated, suggesting a potential interaction. This should be pharmacologically proved and the need to reduce the dose of RB when used with RTV 100 mg bid in combination with other PI should be evaluated clinically. |
| P189 | DRUG INTERACTIONS BETWEEN ANTIRETROVIRAL DRUGS AND OTHER ORAL MEDICATIONS IN AN HIV+ POPULATION 1997–1999 Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P189 AIDS 2000, Oct 22-26;14(Suppl. 4);S70 J. Stansell1, R. Slaker2, E. Hamel2 and D. Lapins2 In this cohort of HIV+ patients, potentially serious interactions between ARV and other medications increased from 1997 to 1999, with 60 out of 249 patients (24%) experiencing at least one potential interaction over the time period. Despite increasing CD4+ counts and stable viral loads, the number of drugs prescribed for non-HIV-related conditions has continued to rise over time. |
| P190 | EFFICACY AND INTOLERANCE OF INDINAVIR IN ONE HUNDRED ITALIAN PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P190 AIDS 2000, Oct 22-26;14(Suppl. 4);S71 A. Di Biagio, A. Beltrame, C.R. De Pascalis, B. Bucci, A. Collidà, R. Rosso, M. Bassetti, G. Gatti and D. Bassetti The relationship found between virologic efficacy and renal and hepatic toxicity may reflect the high interpatient variability in drug exposure due to variability in pharmacokinetics and adherence. The personalization of IDV dosage regimen based on IDV plasma concentrations may result in optimization of the efficacy/toxicity ratio in adherent patients. |
| P191 | TOLERABILITY OF ANTIRETROVIRAL TREATMENT DURING PREGNANCY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P191 AIDS 2000, Oct 22-26;14(Suppl. 4);S71 V. Del Bono, M. Vassallo, E. Pontali and D. Bassetti Our study showed fairly good adherence and tolerability of anti-HIV drugs in pregnancy with an acceptable rate of discontinuation because of adverse events. Actually, no serious AE occurred in mothers and no child surely suffered from treatment-related AE. Moreover, no unexpected AE occurred both in mothers and children. Use of i.v. illicit drugs did not influence adherence to treatment. During last two years combination antiretroviral therapy was increasingly employed, so, in the next future, we will need to perform further studies to access the tolerability of more complex regimens. |
| P192 | TIME TO DISCONTINUATION OF THE FIRST HAART REGIMEN: A COMPARISON BETWEEN PI- AND NNRTI CONTAINING REGIMENS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P192 AIDS 2000, Oct 22-26;14(Suppl. 4);S71 M. Dorrucci1, P. Pezzotti1, G. Antonucci2, G. Pastore2, T. Prestileo2, F. Resta2, C. Arici2, L. Caggese2 and A. d’Arminio Monforte2 More than one third of patients discontinued their initial HAART regimen after one year of therapy, without any differences between PI- and NNRTI-containing regimens. |
| P193 | CURE OF CHRONIC HEPATITIS B AFTER HEPATITIS B VIRUS REACTIVATION AND SEVERE HEPATITIS DURING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P193 AIDS 2000, Oct 22-26;14(Suppl. 4);S72 Christoph Manegold1, Manfred Dietrich1, Charles Hannoun2, Anett Wywiol1, Susanne Polywka3 and Stephan Günther2 Therefore, after commencement of HAART, HBs antigen-positive as well as HBs antibody-positive patients should be closely monitored for HBV reactivation. Interestingly, the long-term outcome of hepatitis B flare-up may be beneficial in terms of recovery from chronic hepatitis B infection in HIV-positive patients treated by HAART. |
| P194 | A HYPERCOAGUABLE STATE ASSOCIATED WITH PROTEASE INHIBITOR CONTAINING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (PI-HAART) IN HIV-1 INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P194 AIDS 2000, Oct 22-26;14(Suppl. 4);S72 K. Koppel, G. Bratt, B. Lund, E.-L. Fredriksson and E. Sandström PI-HAART was discriminating as a predictive factor for increased PAI-1 levels. Considering other metabolic changes found in this patient group, these findings also suggest a hemostatic dysbalance secondary to PI-HAART related dyslipidemia and decreased insulin sensitivity. The elevated levels of PAI-1 and fibrinogen indicate deviations of the hemostatic system consistent with increased thrombogenicity as a further CHD risk in association to PI-HAART. |
| P195 | HIGH INCIDENCE OF KIDNEY STONES AND RENAL FUNCTION DISTURBANCE ASSOCIATED WITH INDINAVIR THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P195 AIDS 2000, Oct 22-26;14(Suppl. 4);S72 B. Åkerlund, U. Flamholc, K. Koppel, P. Nilsson, Ö. Mortimer, A. Sundström, G. Steineck and L. Morfeldt Renal colic was reported by 18% of patients exposed to indinavir, a much greater proportion than previously reported. Mean serum creatinine was significantly higher in patients on indinavir compared to patients on other antiretroviral therapy. This raises concern about renal function in patients receiving indinavir. |
| P196 | HIV-ACUTE ENCEPHALITIS (HAE) IN STABLE ASYMPTOMATIC HIV INFECTION DURING HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P196 AIDS 2000, Oct 22-26;14(Suppl. 4);S72 G. Gattuso, R. Caudana1, D. Confalonieri, P. Costa, G. Fibbia, S. Miccolis, B. Morandini, G. Perboni, A. Scalzini and D. Tomasoni A reasonable explanation of this case is a reduced effect of HAART on the CNS because of limited CSF penetration of drugs; a second hypothesis is the acquisition, promoted by antiretroviral therapy, of non conventional mutations that conferred resistance to antiretrovirals and/or induced major neurovirulence. The authors stress the importance of pharmacokinetic parameters on individualization of HIV therapy, especially the ability of drugs to cross blood-encephalic barrier and evaluation of CF HIV-RNA in case of therapeutic failure. |
| P197 | PREVENTION OF SEVERE DRUG-RELATED ANEMIA IN AIDS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P197 AIDS 2000, Oct 22-26;14(Suppl. 4);S73 A. Mastroianni, C. Cancellieri, F. Allegrini and S. Pignatari rHuEPO was a safe and effective treatment for the prevention of severe anemia caused by drug haematological toxicity. We suggest that the administration of rHuEPO should be considered in AIDS patients with moderate drug-related anemia. As a matter of fact, rHuEPO use may prevent the development development of severe drug-related anemia in this setting by ameliorating haemopoietic suppression induced by antiretroviral agents associated with drugs directed at opportunistic viral, fungal, bacterial, and/or protozoal infections. |
| P198 | PRIMARY PULMONARY HYPERTENSION AND HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P198 AIDS 2000, Oct 22-26;14(Suppl. 4);S73 R. Palacios, J.L. Velasco, E. Gálvez, M. González, J. Ruiz, M. Márquez, J. Santos and P. González HIV-associated PPH usually affects drug abusers, with chronic liver disease and variable immunodepression. It is more frequent than in HIV negative subjects and differs from these in some aspects: male predominance, younger patients, more frequent hepatopathy and less survival. |
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5 IMMUNOLOGY AND IMMUNE-BASED STRATEGIES AND THERAPIES Abstracts P199 thru P211, Pages S73 TO S77 |
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| P199 | ACUTE VIRAL LOAD BLIPS IN RESPONSE TO SUBCUTANEOUS INTERLEUKIN-2 THERAPY IN HIV-1 INFECTED INDIVIDUALS ON HIGHLY ACTIVE ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P199 AIDS 2000, Oct 22-26;14(Suppl. 4);S73 A.K. Sullivan, N. Imami, G.A.D. Hardy, A. Pires, B. O’Donavan, F.M. Gotch, B.G. Gazzard Additional HIV-1 specific lymphoproliferative data will be presented. In conclusion in HIV-1 infected individuals on HAART IL-2 induces a small acute elevation in viral load which is not sustained. NK cells rise acutely and remain elevated at follow up. There is no acute effect on CD4 T cell count which rises significantly after completion of the treatment cycles. It may be that this IL-2 induced, HAART controlled autovaccination could be a viable alternative to structured treatment interruption and clearly warrants further investigation. |
| P200 | INTERLEUKIN-2 THERAPY IN HIV-1 INFECTED INDIVIDUALS WITH LATE STAGE DISEASE AND FAILING ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P200 AIDS 2000, Oct 22-26;14(Suppl. 4);S74 A.K. Sullivan, M.R. Nelson, A.L. Pozniak and B.G. Gazzard In conclusion in this group of patients IL-2 therapy caused no serious side effects and no clinical events occurred during the treatment period. The mean CD4 T cell count of the group rose to > 20 cells/µl; a reported survival advantage. All patients subsequently entered the EAP. It may be patients with advanced stage disease require a greater number of cycles or ongoing IL-2 therapy to achieve a sustained beneficial effect. In this small study it would appear IL-2 was an effective therapeutic intervention while awaiting EAP and warrants consideration in patients with very advanced disease. |
| P201 | WF10 INDUCED MODIFICATION OF MACROPHAGE FUNCTIONAL STATE AS AN ADJUNCTIVE THERAPY FOR HIV DISEASE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P201 AIDS 2000, Oct 22-26;14(Suppl. 4);S74 M. McGrath1, B. Herndier1, J. Kahn1, A. Elbaggari1, S. Meuer2 and T. Giese2 In studies presented here, WF10 appeared to cause dramatic changes in macrophage gene expression in vitro and in vivo with a change from an inflammatory to an anti-inflammatory genotype as measured by RT-PCR with the Lightcycler system. |
| P202 | I-152, A PRO-GSH DRUG WITH SIGNIFICANT ANTIOXIDANT, ANTI-INFLAMMATORY AND ANTI-HIV EFFECTS IN MACROPHAGES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P202 AIDS 2000, Oct 22-26;14(Suppl. 4);S74 P. Mialocq1, P. Clayette 1,2, A.-C. Rimaniol1, J. Oiry2, J-Y. Puy3, N. Dereuddre-Bosquet 1,2, P. Fretier1, J.-L. Imbach3 and D. Dormont1 Altogether, these results suggest that I-152 could be beneficial as therapeutic agent in HIV-1-infected patients: 1) to restore intracellular GSH content, and 2) to decrease HIV replication in combination with antiretroviral molecules. Moreover, this molecule could be of interest to decrease deleterious mitochondrial damages induced by AZT and other NRTI. |
| P203 | ANALYSIS OF THE HIV-1 SPECIFIC T-CELL REPERTOIRE IN HIV-1 INFECTED PATIENTS ON HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P203 AIDS 2000, Oct 22-26;14(Suppl. 4);S75 E. Harrer, M. Schmitt, S. Kastel, S. Bergmann, S. Marx, J.R. Kalden1 and T. Harrer1 Many patients, even in advanced stages of HIV-infection can mount a polyclonal CTL response against several proteins. After introduction of HAART there is an improvement of the HIV-specific CTL response in most of the patients. Prolonged suppression of HIV by potent HAART regimens, however, is associated with a decrease of HIV-specific CTL in the peripheral blood due to the reduction of the antigenic stimulus. |
| P204 | PHENOTYPIC T CELL CHANGES IN HIV-1 INFECTED INDIVIDUALS RECEIVING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P204 AIDS 2000, Oct 22-26;14(Suppl. 4);S75 A.K. Sullivan, A. Pires, G.A.D. Hardy, F.M. Gotch, B.G. Gazzard and N. Imami In conclusion 16 weeks of HAART resulted in an increase in CD4 memory T cells and CD28 expression. There was a decline in CD8 memory T cells and activation markers. IL-2 receptor expression is low in HIV-1 infected individuals and was not affected by HAART. |
| P205 | A NOVEL LYMPHOCYTE POPULATION IN PERIPHERAL BLOOD OF HIV PATIENTS: EFFECT OF HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P205 AIDS 2000, Oct 22-26;14(Suppl. 4);S75 D. Turner, I. Yust, M. Fried, M. Hoffman, M. Bleiberg, N. Vardinon, M. Burke and B. Tartakovsky This new CD14-like positive lymphocyte population may represent an important component of the cellular events associated with HIV infection. Based on its modulation following HAART, it may be used as a drug-monitoring cellular marker in antiretroviral treatment. |
| P206 | THE INFLUENCE OF GRANULOCYTE COLONY-STIMULATING FACTOR ON HIV-1 RNA IN PATIENTS WITH CMV RETINITIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P206 AIDS 2000, Oct 22-26;14(Suppl. 4);S75 M. Davidson, Y.-I. Min, J.T. Holbrook, T.C. Quinn, R. Murphy, D.A. Jabs, W. Welch and C.L. Meinert for the Studies of Ocular Complications of AIDS Research Group (SOCA) Use of G-CSF to reverse neutropenia occurring in HIV infection did not affect mean levels, or crude mean rate of change of log10 HIV-1 RNA. However, our adjusted results suggest a reduced rate of decline in viral load may be associated with exposure to G-CSF. If G-CSF is used in the setting of HIV therapy and persistent levels of detectable HIV RNA, further studies are justified. |
| P207 | T-CELL VACCINATION IN HIV INFECTION: A PHASE I CLINICAL TRIAL Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P207 AIDS 2000, Oct 22-26;14(Suppl. 4);S76 R. Abulafia-Lapid, Z. Bentwich, Y. Keren-Zur, I. Cohen and H. Atlan No toxicity effect was observed in all patients injected. Changes in CD4 levels following vaccination with no significant effect on HIV plasma viral load was observed in some patients. However, this is only a phase I clinical trial, designed to evaluate safety and feasibility. It offers a novel approach for the treatment of HIV infection which will have to be tested in a larger number of patients. |
| P208 | GRANULOCYTE COLONY STIMULATING FACTOR (G-CSF) USE AND MORTALITY IN PATIENTS WITH AIDS AND CMV RETINITIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P208 AIDS 2000, Oct 22-26;14(Suppl. 4);S76 Y.-I. Min, M. Davidson, J.T. Holbrook, M. Van Natta, D.A. Jabs, R. Murphy, W. Welch, C.L. Meinert for Studies for Ocular Complications of AIDS (SOCA) This study suggests that G-CSF use may prolong survival (i.e., a 20 to 56% reduction in mortality) in HIV-infected patients and this survival benefit may not be limited to patients who were neutropenic. Further research is warranted to confirm these findings and elucidate the role of G-CSF use on survival in the context of HAART therapy. |
| P209 | CHANGES IN IGG SUBCLASS 1 CORRELATES WITH THE EFFECTS OF 120 WEEKS ON HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P209 AIDS 2000, Oct 22-26;14(Suppl. 4);S76 P. Voltersvik, B. Åsjo, A.M. Dyrhal Riise, B. Sørensen and E. Ulvestad A parallel reduction of IgG and specific HIV-1 IgG1 subclass within 12 weeks is interpreted as an expression of reduced activation of the immune system [1]. This study demonstrates an excess of specific IgG1 between 12 and 48 weeks, probably as a consequence of a very pronounced reduction in viral load rather than an increase in IgG1 production. Long-term reduction in IgG1 is paralleled by sustained suppression of HIV-1 viral load. |
| P210 | BLOOD MX-LEVEL IN HIV-PATIENTS DEPEND ON THE STAGE OF THE DISEASE AND THEIR TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P210 AIDS 2000, Oct 22-26;14(Suppl. 4);S76 P. V. Wussow, S. Stenzel, B. Krümmel and B. Kuhlmann These data demonstrate that endogenous IFN-production can significantly be reduced by videx, zerit and viramune/sustiva. Interestingly, an endogenous IFN production is sometimes measurable in HIV-patients even in the absence of measurable HIV-RNA in plasma. |
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6 PAEDIATRIC TREATMENT Abstracts P211 thru P235, Pages S77 TO S83 |
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| P211 | MEASUREMENT OF THYMUS VOLUME AS A PROGNOSTIC PARAMETER IN PATIENTS STARTING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P211 AIDS 2000, Oct 22-26;14(Suppl. 4);S77 R. Manfredi1, G. Battista2, K. Fiorini1, R. Canini2 and F. Chiodo1 A significant correlation was recently found between the increase of both thymic volume and function and the response to HAART in congenitally- infected children [3,4]. However, the relationship between virologic outcome and thymic morphology and function during HAART, remains controversial. According to our preliminary data, thymus size measured through a simple CT scan technique, seems to reliably predict the laboratory response to initial HAART, in antiretroviral-NAÏVE patients. Further investigation is warranted in this field, since the study of different morphological and functional parameters of thymus might shed light on the varied immune response to HAART observed at extremes of age, as well as on the occurrence of an immunological outcome significantly dissociated from the virologic one. |
| P212 | BABY COCKTAIL!—A PALATABLE FOUR DRUG COMBO FOR HIV INFECTED INFANTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P212 AIDS 2000, Oct 22-26;14(Suppl. 4);S77 E.G.H. Lyall, S. Head, M.D.S. Walters and G. Tudor-Williams for the Family HIV Team All infants, but one, were commenced on treatment during first admission. Multidisciplinary team support has been crucial in helping families with starting and maintaining adherence to treatment. By historical comparison with infants on problematic PI containing regimens, parents have reported few difficulties with infants accepting this more palatable regime. We would also contend that this regime with better adherence leads to better viral suppression. |
| P213 | THE TOLERANCE AND EFFICACY OF ANTIRETROVIRAL THERAPY IN HIV INFECTION CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P213 AIDS 2000, Oct 22-26;14(Suppl. 4);S77 Gh. Jugulete, M. Drãgan, A.M. Tudor, D. Duma, E. Gheorghe, M. Mãrdãrescu, R. Mãntescu, C. Petre, S. Petrea, A. Stãncescu not available |
| P214 | ANTIRETROVIRAL RESISTANCE IS COMMON IN HIV-1 INFECTED CHILDREN FAILING TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P214 AIDS 2000, Oct 22-26;14(Suppl. 4);S77 S.C. Leech1, J. Mullen1, S. O’Shea2, I.L. Chrystie1, G. du Mont2, C. Ball3, M. Sharland4, F. Cottam2, M. Zuckerman3, P. Rice4 and P. Easterbrook1 The Visible Genetics assay functioned efficiently with non-B subtypes of HIV. Genotypic resistance is common among HIV-infected children failing antiretroviral therapy. If available at the time, this information may have influenced clinical management. |
| P215 | RESCUE THERAPY IN PI-EXPERIENCED PAEDIATRIC PATIENTS: CHARACTERISATION OF BASELINE VIRAL PROTEASE AND CORRELATES OF VIROLOGICAL RESPONSE TO AMPRENAVIR-CONTAINING REGIMENS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P215 AIDS 2000, Oct 22-26;14(Suppl. 4);S78 M.F. Maguire1, A. Klein1, S. Randall1, D. Paterson2, P. Nacci2, N. Mustafa3, H. Cox2, J. Yeo2, W. Snowden1 and J.P. Kleim1 Evaluation of overall protease sequence divergence from a consensus has been shown to have prognostic value in this setting. This analysis is straightforward to perform and makes no a priori assumptions about the significance of individual mutations. Our data indicate that APV can be an important component of rescue therapy for PI-experienced subjects when active RT inhibitors are included, especially when subjects are switched before viral protease has evolved multiple non-clade B substitutions. |
| P216 | ADHERENCE TO PAEDIATRIC ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P216 AIDS 2000, Oct 22-26;14(Suppl. 4);S78 S. Donaghy, S. Waugh, C. Wallace, S. Hooban, Z. Mitchla and M. Sharland This study shows that most children miss doses of ART. Given the importance of high levels of adherence in paediatric HIV therapy, further studies of non-adherence and intervention strategies are urgently required. |
| P217 | THE EFFICACY AND TOLERANCE OF ANTIRETROVIRAL COMBINATION CONTAINING EFAVIRENZ (STOCRIN) IN HIV-INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P217 AIDS 2000, Oct 22-26;14(Suppl. 4);S78 S. Petrea, M. Iosipenco, M. Popa, A.M. Tudor, G. Jugulete, L. Darasteanu, D. Duma, M. Luminos, M. Mardarescu, R. Mantescu, E. Gheorghe, C.A. Petre, C. Streinu and E. Fedorovici All combinations of EFV have similar and very good efficacy in naïve and experienced HIV-infected children. EFV was very well tolerated in these combinations. The study will continue for all the children who experienced good efficacy of EFV in combination offering very good quality of surviving. |
| P218 | EFFICACY OF EFAVIRENZ (EFV) BASED COMBINATIONS IN HIV-1 INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P218 AIDS 2000, Oct 22-26;14(Suppl. 4);S78 D. Duiculescu, E. Ungureanu, C. Oprea, R. Rădoi, D. Ispas, L. Ene, E. Voicu, E. Ceauşu, P. Calistru and L. Păun Preliminary data from this ongoing study suggest that combination therapy containing EFV was effective in naïve and pretreated children. All patients had a good virologic and immunologic response and no clinical progression of the disease occurred. EFV was well tolerated and the adherence to therapy was good. |
| P219 | EFAVIRENZ AND INDINAVIR REGIMEN IN CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P219 AIDS 2000, Oct 22-26;14(Suppl. 4);S79 Rodica Costa, M. Serban, A. Isac1, M. Lesovici, D. Mihailov, E. Naidan2 and E. Resiga3 The regimen with EFV+IDV was well tolerated in most of the cases. The immunological response was significant, comparable with those mentioned in clinical trials. The compliance at treatment was good in 88.23% of the cases. |
| P220 | NUTRITIONAL AND IMMUNE EFFECTS OF EFAVIRENZ AND INDINAVIR REGIMEN IN HIV HORIZONTALLY INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P220 AIDS 2000, Oct 22-26;14(Suppl. 4);S79 A. Cupsa, C. Gheonea, C. Ecobici, A. Georgescu, M. Marinescu, E. Volosciuc, P. Surugiu, T. Poajga and S. Dinescu EFV and IDV combined antiretroviral therapy determined at the studied group of HIV infected children both nutritional and immune status improvement, regardless the initial severity of immunodeficiency and/or nutritional status. |
| P221 | REDUCTION OF VIRAL LOAD IN PAEDIATRIC HIV-INFECTED PATIENTS ON ANTIRETROVIRAL TRIPLE THERAPY INCLUDING EFAVIRENZ Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P221 AIDS 2000, Oct 22-26;14(Suppl. 4);S79 M. Funk, R. Linde, T. Schuster, G. Notheis1 and U. Wintergerst1 Suppression of plasma HIV-1 RNA below 400 copies/ml seems to be difficult in children < 24 months with triple therapy including efavirenz. A quadruple therapy should be considered. Pharmacokinetic studies in small children are necessary and should be helpful to find adequate EFV dosage and mode of application. |
| P222 | NELFINAVIR PHARMACOKINETICS IN HIV-INFECTED CHILDREN: A COMPARISON OF TWICE-DAILY AND THREE-TIMES-DAILY DOSING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P222 AIDS 2000, Oct 22-26;14(Suppl. 4);S79 T. Schuster, R. Linde, M. Funk, D. Mentzer, D. Dunsch, D. Hofmann and W. Kreuz These pharmacokinetic data support NFV bid application. A twice-daily administration of all antiretroviral drugs is better adapted to a child's normal lifestyle and therefore should increase compliance. |
| P223 | GENOTYPIC AND PHENOTYPIC RESISTANCE IN PAEDIATRIC HIV-INFECTED PATIENTS ON AN ANTIRETROVIRAL TRIPLE THERAPY INCLUDING NELFINAVIR Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P223 AIDS 2000, Oct 22-26;14(Suppl. 4);S80 R. Linde, D. Mentzer, M. Funk, T. Schuster, D. Dunsch, W. Kreuz and D. Hofmann not available |
| P224 | INDINAVIR IN HIV/AIDS INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P224 AIDS 2000, Oct 22-26;14(Suppl. 4);S80 I. Darasteanu, S. Petrea, M. Luminos, M. Mardarescu, A. Stancescu, A. Streinu Cercel not available |
| P225 | ABT-378/RITONAVIR (ABT-378/R) IN HIV-INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P225 AIDS 2000, Oct 22-26;14(Suppl. 4);S80 P. Cahn1, C. Renz11, C. Deetz11, Y. Xu11, X. Saez-Llorens2, A. Violari3, P. Gomez4, E. Handelsman5, S. Pelton 6, O. Ramilo7, E. Chadwick8, S. Arpadi9, U. Allen9, R. Bertz 11 and E. Sun11 No statistically significant difference in antiviral activity was noted for subjects < 2 years old or ≥ 2 years old. Two subjects have discontinued from the study at Week 40. One of these discontinuations was as a result of an ABT-378/r related AE. The most commonly reported AE of at least moderate severity and probable, possible or unknown relationship to ABT-378/r was rash (2%). Based on the pediatric grade criteria used by the PACTG, no Grade 3 or higher elevations in triglycerides or cholesterol were observed. Only one Grade 2 elevation in triglyceride (976 mg/dl) was observed. |
| P226 | AMPRENAVIR IN PI-NAÏVE AND PI-EXPERIENCED PAEDIATRIC PATIENTS: VIRAL GENOTYPIC AND PHENOTYPIC ANALYSES AND CORRELATION WITH TREATMENT OUTCOME Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P226 AIDS 2000, Oct 22-26;14(Suppl. 4);S80 S. Randall1, J. Yeo2, D. Paterson2 and W. Snowden1, on behalf of the PROB2004 study team In summary, minimal cross-resistance to APV was detected in baseline isolates from PI-experienced paediatric patients and mutations characteristic of APV resistance were acquired during subsequent APV/NRTI therapy, indicating that antiviral selective pressure occurred. The presence at baseline of multiple key PI resistance mutations was demonstrated to be a statistically significant predictor of treatment outcome. |
| P227 | GENOTYPIC AND PHENOTYPIC RESISTANCE IN HIV-1 INFECTED CHILDREN EXPERIENCING HAART FAILURE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P227 AIDS 2000, Oct 22-26;14(Suppl. 4);S80 F. Salvini1, S. Rusconi2, E. Boeri3, S. La Seta Catamancio2, E. Bulgheroni2, C. Giovanettoni1, R. Pinzani1 and A. Plebani1 The phenotype correlated with the patient outcome data among the responders (all patients whose viruses retained drug sensitivity were clinically and virologically responders) while the genotype data correlated better among the non responders (all the patients that switched from one PI to another following the genotype data had a reduction in viral load). Further studies are warranted to define the role of resistance assessment in the long-term follow up of the HIV-1-infected children in our cohort. |
| P228 | TREATMENT OF HIV INFECTED CHILDREN WITH INDINAVIR, ZIDOVUDINE AND LAMIVUDINE: TWO-YEAR FOLLOW-UP Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P228 AIDS 2000, Oct 22-26;14(Suppl. 4);S81 A.M.C. vanRossum1, N.G. Hartwig1, T.F.W. Wolfs2, S.P.M. Geelen2, C.M.R. Weemaes3, H.J. Scherpbier4, E.G. van Lochem6, M. Schutten7, D.M. Burger5, A.D.M.E. Osterhauss7 and R. de Groot1 on behalf of the Dutch Study Group for Children with HIV Infection After 2 years of therapy, in 74% of the children an optimal response is seen on therapy both clinically, immunological and virological. Side-effects of HAART were mild. |
| P229 | ANTIRETROVIRAL TOXICITY IN NEONATES EXPOSED TO MONO- DOUBLE OR TRIPLE THERAPY FOR 6 WEEKS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P229 AIDS 2000, Oct 22-26;14(Suppl. 4);S81 Normand Lapointe1, J. Samson, V. Pelletier, M. Lemay, A.C. Bonnin, M. Boucher, S. Valois and A. Khammy Grade 2 toxicity for anemia and neutropenia was found in 10% (7/64) with ZDV 13.5% (5/37) with ZDV/3TC and 23% (6/26) with ZDV/3TC/ nelfinavir, a respective relative risk (RR) of 0.23, 0.29 and 0.48 over a period of 90 days, However only 2/123 children experienced grade 3 toxicity for hemoglobin (< 7.0 g) with ZDV/3TC. A slight but manageable toxicity is experienced with the use of double and triple therapy. |
| P230 | RITONAVIR TROUGH CONCENTRATION AS A PREDICTOR FACTOR OF VIROLOGIC RESPONSE IN HIV INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P230 AIDS 2000, Oct 22-26;14(Suppl. 4);S81 G. Gatti, S. Boni, E. Pontali, C.R. De Pascalis, E. Mazzarello, A.R. Gigliotti, M. Bassetti and D. Bassetti Our observation of a trend for a greater decrease of viral load in patients with higher trough concentration of RTV warrants further pharmacodynamic studies of protease inhibitors in pediatric patients. |
| P231 | IS IT POSSIBLE TO IMPROVE ADHERENCE TO COMBINATION ANTIRETROVIRAL TREATMENT IN CHILDREN? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P231 AIDS 2000, Oct 22-26;14(Suppl. 4);S81 E. Pontali, M. Feasi, F. Toscanini, P. De Gol, A. Nuzzolese and D. Bassetti It is necessary to work more to improve taste and palatability, to realise bid or qd regimens, to make available smaller pills and liquid formulations and to avoid food interactions. However, compliance to antiretroviral therapy in children seems a difficult but not impossible goal. |
| P232 | POOR VIROLOGICAL RESPONSES IN CONTRAST TO IMMUNOLOGICAL BENEFITS FROM HAART IN BRAZILIAN HIV-1 INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P232 AIDS 2000, Oct 22-26;14(Suppl. 4);S82 D.M. Machado1,2, M.I.B.F. Lopes2, L. Hornke1 and R.C.M. Succi1 We show how difficult is to achieve and maintain the suppression of HIV replication for long periods in pediatric daily practice. However, the benefits from HAART on immunological reconstitution cannot be underestimated. |
| P233 | TRIPLE THERAPY CONTAINING NELFINAVIR IN HIV INFECTED CHILDREN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P233 AIDS 2000, Oct 22-26;14(Suppl. 4);S82 A.M. Tudor, M.I. Dragan, M. Mardarescu, M. Luminos, S. Perrea and G. Jugulete We have studied 28 children treated with combinations of antiretroviral drugs containing nelfinavir. Twenty-seven patients received NFV+ 2 NRTI. One case was treated with NFV+ZDV+EFV. In 53.5% cases we obtained durable suppression of viral load over 12 months. The treatment failure was noticed in 42.8% cases. The triple therapy was stopped in 10.7% cases because of adverse reactions (lipodystrophy, diarrhea). The tolerability of the regimen was good. There was no fatal adverse reaction. |
| P234 | RITONAVIR IN PAEDIATRIC HIV CARE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P234 AIDS 2000, Oct 22-26;14(Suppl. 4);S82 Gabriel Munteanu, Georgeta Constantinescu and Sorin Petrea 92.6% of the patients had an undetectable viral load at 6 months of therapy. Conclusions The contribution of the treatment with RTV is certainly positive in the different combinations ARV given to the HIV/AIDS children. |
| P235 | SERIOUS BACTERIAL INFECTIONS IN HIV-INFECTED CHILDREN IN THE ERA OF COMBINATION ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P235 AIDS 2000, Oct 22-26;14(Suppl. 4);S83 M. Feasi, R. Rosso, S. Vasile, E. Pontali and D. Bassetti Incidence of serious bacterial infections decreased during these years. It occurred in the recent period characterised at first by the introduction of combination antiretroviral treatment and later by the use of protease inhibitors. In the same time, the use of IVIG prophylaxis decreased. However, low protective effect of IVIG was observed; in fact 75% of infective episodes were observed in patients who received IVIG prophylaxis in the previous 6 months. |
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7 THERAPEUTIC INITIATIVES IN THE DEVELOPING WORLD Abstracts P236 thru P257, Pages S83 TO S89 |
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| P236 | ALLOPURINOL/DIDANOSINE INTERACTION: A FURTHER STEP TOWARD LESS EXPENSIVE ANTI-HIV THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P236 AIDS 2000, Oct 22-26;14(Suppl. 4);S83 Johan R. Boelaert1, Richard M.W. Hoetelmans2, Genevive Dom3, Joep M.A. Lange4 Pharmacological boosting of ddI by ALL may allow to halve ddI dosage. This should be of particular interest to resource-poor countries. |
| P237 | INDIAN SCENARIO OF ANTIRETROVIRAL (ARV) THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P237 AIDS 2000, Oct 22-26;14(Suppl. 4);S83 D.G. Saple, K.-S. Satish and Ravi Vadrevu ARV is effective but needs increased compliance. Suggestions To Study (1) CD4 count of normal Indian population (2) Resistance profile in drop out and dual therapy cases (3) Interruption therapy (4) Cytokine use. (5) Alternative medicines (6) Continue long term follow-up. |
| P238 | COMMUNITY DIRECTLY OBSERVED THERAPY (DOT) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P238 AIDS 2000, Oct 22-26;14(Suppl. 4);S83 Susan Rachel Basirika The most important drug therapy in HIV infection is home and community involvement in early detection, consistent treatment of infections and care for the infected. |
| P239 | PREVALENCE AND TYPES OF OPPORTUNISTIC FUNGAL INFECTIONS IN HIV/AIDS PATIENTS IN NIGERIA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P239 AIDS 2000, Oct 22-26;14(Suppl. 4);S84 E. Ekong1, A. Uwah2 and I. Grant3 HIV patients easily developed fungal infections; those who start ARV therapy early having lesser and non-complicated infections. Those with low CD4+ count had more severe and often complicated deep infections. Azole resistance is quite common and easily responds to other drugs. |
| P240 | CLINICAL EVALUATION OF INDINAVIR (IDV) IN COMBINATION WITH AZT + 3TC AND D4T + 3TC IN HIV INFECTED PATIENTS IN THREE NIGERIAN CENTRES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P240 AIDS 2000, Oct 22-26;14(Suppl. 4);S84 E. Ekong1, A. Uwah2 and I. Grant3 Indinavir in combination with nucleoside analogues is well tolerated, has a remarkable effect on the improvement on the immune state and disappearance of opportunistic infections. Both regimens were well tolerated and effective, but D4T+3TC+IDV gives a more sustained clinical improvement though with more side effects and may be better in our setting. |
| P241 | FACTORS CONTRIBUTING TO REPORTED HIGH DEFAULTER RATES AMONG PATIENTS ON TB TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P241 AIDS 2000, Oct 22-26;14(Suppl. 4);S84 Rebecca Sebikejje, Samalie Matovu and Jovah Kamatene Poor statistics are largely responsible for reported high defaulter rates. From other findings in the study, DOTS is not being used correctly. Participation of peer educators and family members could improve compliance. |
| P242 | TB SCREENING IN PATIENTS WITH HIV/AIDS IN SOUTH INDIA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P242 AIDS 2000, Oct 22-26;14(Suppl. 4);S84 RB. Rayapu, K.A. Ramaiah, P. Srinivasulu, J.V. Ramaiah, R. Anand, P. Satish Babu, S. Ramola and R.V. Kumari Proper awareness should be generated about TB in AIDS. The TB drugs should be provided free of cost. The clinicians need training to pay more attention to the possible diagnosis of TB in PLW HIV/AIDS and to the need for careful follow up is very much essential in countries like India. |
| P243 | HIV/TUBERCULOSIS (TB) LIAISON NURSE IN THE HIV/AIDS CLINIC Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P243 AIDS 2000, Oct 22-26;14(Suppl. 4);S85 Solomon Kapere Improved communication between TB and HIV/AIDS service providers has been enormously successful for improved medical care of HIV/AIDS coinfected patients. Assigning a nurse/any medical personnel in HIV/AIDS clinics as a TB liaison officer to the public health units will ensure better HIV/AIDS care and management. |
| P244 | THE EFFICACY OF NNRTI-CONTAINING ANTIRETROVIRAL REGIMEN IN CLINICAL PRACTICE: EXPERIENCE IN A RESOURCE LIMITED SETTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P244 AIDS 2000, Oct 22-26;14(Suppl. 4);S85 Anthony Kebba, Diana Atwine and Raymond Mwebaze Though not conclusive, in the absence of clinical trials to assess efficacy, the above findings reflect significant trends that could serve as guidelines or tailor the use of NNRTIs in HIV-1 management in our patient population and setting. |
| P245 | USE OF SINGLE DOSE NEVIRAPINE OR AZIDOTHYMIDE IN THE PREVENTION OF HIV TRANSMISSION FROM MOTHER TO INFANTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P245 AIDS 2000, Oct 22-26;14(Suppl. 4);S85 Ronald Kiwanuka Mwanje A single oral dose of NVP given to HIV infected women at the onset of labour and to the infant within 72 h after birth reduces the risk of HIV transmission during the first 14–16 weeks of life by 50% compared to AZT regimen. Using this simple and inexpensive NVP can significantly reduce mother to child transmission of HIV in poor resource countries like Uganda. |
| P246 | A STUDY OF QUALITY OF LIFE IN TERMINALLY ILL INDIVIDUALS INFECTED WITH HIV/AIDS AND ITS RELATIONSHIP TO TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P246 AIDS 2000, Oct 22-26;14(Suppl. 4);S86 Robinah Navuga Most investigators on the study argued that concepts such as (a) satisfaction with housing, (b) income/standard of living, (c) personal safety, (d) freedom from discrimination, (e) spiritual fulfilment, (f) leisure and recreation, (g) sexual life, (h) self esteem, (i) pain, (j) happiness must be included in studies of QOL if such studies are to measure an individual’s true life experience. QOL regarding HIV differ among physicians, PLWH/A and care givers. Disseminating information about QOL empower PLWH/A to seek appropriate treatment. |
| P247 | COMBINATION THERAPY: WAY FORWARD FOR WOMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P213 AIDS 2000, Oct 22-26;14(Suppl. 4);S86 Mable Mirembe not available |
| P248 | ACCESS OF WOMEN TO ANTIRETROVIRAL (ARVS) THERAPY: HOW EFFECTIVE IS COUNSELLING? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P248 AIDS 2000, Oct 22-26;14(Suppl. 4);S86 J.K. Nabalonzi, C. Somoka and E. Katamujuna Limited access to ARVS (especially by women) raises a lot of social, economic, legal and ethical concerns. Counselling can be an innovative strategy towards management of HIV/AIDS with ARVS; to spell out issues of partner notification, cost affordability, compliance and continued treatment. |
| P249 | ANTIRETROVIRAL THERAPY: REAL CHALLENGES FOR DEVELOPING WORLD Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P249 AIDS 2000, Oct 22-26;14(Suppl. 4);S86 Janak Maniar and Swati Desai The antiretroviral therapy are real challenges for India because only 1% of HIV infected patients can afford in absence of support organisations. The laboratory tests can be widely spaced, doses modification of few of ARV drugs permissible and dual therapy can be combined with HU to achieve reasonable cost effective response. The triple therapy is ideal if appropriately selected with respect to cost effectiveness. The lack of adherence to ART is a real problem. The intensive counselling to various concerned people including the patient is essential before initiating ART stressing on its life long duration and it is not a cure. |
| P250 | EFFECT OF CHLOROQUINE DERIVATIVE (C/Q) ON CD4 COUNT AND VIRAL LOAD IN HIV-1 INFECTED UGANDANS AT THE JOINT CLINICAL RESEARCH CENTRE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P250 AIDS 2000, Oct 22-26;14(Suppl. 4);S86 J. Takubwa-Mpanga Placebo: rise in CD4 followed by stabilisation at week 4, viral load (copies per mm³) rose from 250,277 at baseline, to 253,947 at week 4, to 312,197 at week 8. Results show that c/q did not perform well probably because, being a chloroquine derivative and the fact that our people are exposed to chloroquine, they could be resistance to it. Then, enrolment was done at a more advanced stage of the disease as compared to the study by Sperber et al. [1] where enrolment was at a viral load of less than 8000 copies per mm³. |
| P251 | THE DILEMMA OF LONG-TERM THERAPY IN MANAGEMENT OF OPPORTUNISTIC INFECTIONS IN HIV INFECTION AND AIDS: THE AIDS SUPPORT ORGANISATION (TASO) EXPERIENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P251 AIDS 2000, Oct 22-26;14(Suppl. 4);S87 Francis B. Kizito Efforts should be made to boost the immunity of clients who are on strong drugs Governments in the underdeveloped world should intensify poverty alleviation schemes to improve the financial capacity particularly of low wage earners (which form the majority of the population). Research into nutrition of people with AIDS should be brought into focus to help come up with affordable but effective nutritional strategies for the underprivileged people. |
| P252 | MEDICAL AND HOMECARE SUPPORT SERVICES: THE AIDS SUPPORT ORGANISATION (TASO) EXPERIENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P252 AIDS 2000, Oct 22-26;14(Suppl. 4);S87 Richard Serunkuuma Medical treatment, counselling, nursing, and home care are all equally good and work hand in hand like a chain. TASO has increasingly become conscious of the fact that management of opportunistic infections is not just about medical care, but also providing education to clients, caregivers, and also involving them in the management of their own health. |
| P253 | PSYCHOSOCIAL CHALLENGES FACED WHILE INITIATING ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P253 AIDS 2000, Oct 22-26;14(Suppl. 4);S87 Swati Desai and J.K. Maniar Many patients who have done well and have been taking ART for 3–4 years like to know how long the effect will sustain and whether such a regular continuation might lead to a cure. It helps to talk about increasing effectivity of newer drugs, and possibility of vaccine development. A small number of patients who might suffer from side effects become very sceptical and anxious. Counselling and some symptomatic relief helps some patients. |
| P254 | EFFECTIVENESS OF MOTHER TO CHILD HIV TRANSMISSION PROPHYLAXIS IN A LOW RESOURCE POPULATION ATTENDING A COMMUNITY HOSPITAL IN SUBURBAN BUENOS AIRES, ARGENTINA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P254 AIDS 2000, Oct 22-26;14(Suppl. 4);S88 V. Valenzuela, J. Abal and M. Romero The implementation of 076 protocol was successful. Compared to other studies, our rate of vertical transmission was very low, probably due to the small size of our population. |
| P255 | SURVIVAL AFTER AIDS DIAGNOSIS IN SOROCABA REGION, S. PAULO STATE, BRAZIL 1985–1997 Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P255 AIDS 2000, Oct 22-26;14(Suppl. 4);S88 R.M.P. Anjos, P.R. Menezes and E.A. Waldman Survival of PWA in population-based study improved significantly in 1997 when highly active antiretroviral therapy was used more aggressively in Brazil, but such improvement was not homogeneous among sex, age, and diagnostic criteria. |
| P256 | ZIDOVUDINE MONOTHERAPY AND ROLE OF LADY HEALTH VISITORS IN PREVENTION OF HIV TRANSMISSION FROM MOTHERS TO INFANTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P256 AIDS 2000, Oct 22-26;14(Suppl. 4);S88 Amna Khatoon, A. Khanani, Aqil Ziyad, S. Ali and S. Shah There has been a lot of interest and community participation and this is a culturally acceptable way of providing health education. We think that a two-pronged approach of utilizing community oriented LHVs is very effective in providing health education and follow up of infected mothers which in turn result in prevention of transmission of infection from mother to child. |
| P257 | ANTIRETROVIRAL THERAPY IMPROVES PROGNOSIS IN AIDS RELATED PULMONARY ASPERGILLOSIS: A CASE STUDY IN MOMBASSA, KENYA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P257 AIDS 2000, Oct 22-26;14(Suppl. 4);S88 Caren Aoko Vincent Invasive pulmonary aspergillosis is a lifetime threatening complication of advanced AIDS, but it does not always lead to short term fatal outcome. An adequate management of HIV infection along with specific antifungal treatment may prolong survival and, as described previously for other AIDS-related disorders, a significant decrease in incidence can be expected. |
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8 USE OF CLINICAL PHARMACOLOGY – PHARMACOKINETIC MONITORING Abstracts P258 thru P294, Pages S89 TO S101 |
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| P258 | TREATMENT FAILURE OF NELFINAVIR-CONTAINING TRIPLE THERAPY CAN LARGELY BE EXPLAINED BY LOW NELFINAVIR PLASMA CONCENTRATIONS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P258 AIDS 2000, Oct 22-26;14(Suppl. 4);S89 D.M. Burger, P.W.H. Hugen, R.E. Aarnoutse, R.M.W. Hoetelmans, on behalf of the ATHENA Study Group Virological failure of NFV-containing triple therapy in treatment-naïve patients can to a large extent be explained by low plasma levels of NFV. Using a threshold NFV CR of 0.90 (or the corresponding peak, trough or AUC values) virological failure can be predicted with an acceptable sensitivity and specificity. |
| P259A | THERAPEUTIC DRUG MONITORING IN THE MANAGEMENT OF SUBJECTS ON THE PROTEASE INHIBITORS NELFINAVIR AND SAQUINAVIR: RESULTS OF THE ROCHE UK TDM SERVICE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P259A AIDS 2000, Oct 22-26;14(Suppl. 4);S89 S.E. Gibbons, H.E. Reynolds, J.F. Tjia, S.H. Khoo, J. Drake1 and J. Back This TDM service has been of value in the management of patients on protease inhibitors which have large interindividual variations in pharmacokinetics. Randomised, controlled studies are required to ascertain whether TDM will improve clinical outcomes relative to current standard of care. |
| P259B | THE LIVERPOOL THERAPEUTIC DRUG MONITORING SERVICE - A SUMMARY OF THE SERVICE AND EXAMPLES OF USE IN CLINICAL PRACTICE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P259B AIDS 2000, Oct 22-26;14(Suppl. 4);S89 S.E. Gibbons, H.E. Reynolds, J.F. Tjia, S.H. Khoo and D.J. Back Although we strongly advocate the need for well designed randomised controlled clinical trials to assess the widespread utility of TDM, our experience encourages us to believe that there is an important role for TDM in clinical practice. |
| P260A | INTERACTION OF NELFINAVIR WITH ATORVASTATIN AND PRAVASTATIN IN NORMAL HEALTHY VOLUNTEERS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P260A AIDS 2000, Oct 22-26;14(Suppl. 4);S90 M. Barry, G. Belz, S. Roll, P. O’Grady, A. Swaminathan, M. Geraldes and B. Mangold In the presence of NEL, ATO exposure is increased > 200% probably due to NEL-induced CYP3A4 inhibition. Unlike ATO, PRA exposure decreased by 35%: possibly due to NEL-induced increase in gastric emptying and/ or increased biliary excretion due to a NEL-related increase in cMOAT activity. Decreased PRA exposure is unlikely to be of clinical significance given the known variable PRA bioavailability. However, increased ATO exposure due to NEL could have implications for its clinical use. |
| P260B | THE EFFECT OF RITONAVIR ON INCREASES IN SAQUINAVIR PLASMA CONCENTRATION IS INDEPENDENT OF RITONAVIR DOSAGE: COMBINED ANALYSIS OF 120 SUBJECTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P260B AIDS 2000, Oct 22-26;14(Suppl. 4);S90 M. Kilby, A. Hill1 and N. Buss1 Ritonavir increases plasma levels of saquinavir by inhibition of first-pass metabolism to raise the Cmax, but with no detectable subsequent effect on plasma half-life. The increase in Cmax and Cmin is comparable for RTV dosages of 100–400 mg. This boosting effect may be different to other approved PIs (indinavir, nelfinavir, amprenavir) where RTV has a lesser effect on Cmax, but may increase the PI plasma half-life in proportion to the dosage of ritonavir used. |
| P261A | PREDICTION OF DRUG POTENCY CMIN/IC50 RATIO: FALSE PRECISION? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P261A AIDS 2000, Oct 22-26;14(Suppl. 4);S90 A. Hill, C. Craig and L. Whittaker Estimates of Cmin and 1C vary widely between treatments in terms of units, statistical methods, adjustments for protein binding and virological assays. Currently Cmin/IC50 or Cmin/IC95 ratios cannot be reliably compared between antiretroviral treatments to predict clinical efficacy. |
| P261B | EFFECTS OF RITONAVIR ON SAQUINAVIR PLASMA CONCENTRATION: ANALYSIS OF 271 PATIENTS IN ROUTINE CLINICAL PRACTICE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P261B AIDS 2000, Oct 22-26;14(Suppl. 4);S90 M. Kurowski, A. Arslan, C. Moecklinghoff1, W. Sawyer2 and A. Hill1 In this population-based PK analysis, the Cmin of saquinavir was dependent on the dosage of saquinavir used and upon whether any ritonavir was given concomitantly, there was no difference between the boosting effects of ritonavir dosages ranging from 100–400 mg bid. These plasma concentrations may be lower than expected from controlled clinical trials, given that this population-based survey is not adjusted for concomitant NNRTI usage, or for adherence with both drug intake and food requirements. |
| P262 | COUPLED CARTRIDGE ENZYMO-IMMUNO-ASSAY FOR AZT AND 3TC TRIPHOSPHATE: COMPLETE AUTOMATION OF THE SAMPLE PREPARATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P262 AIDS 2000, Oct 22-26;14(Suppl. 4);S91 D. Schlemmer1, M. Rigal1, M.C. Nevers1, C. Goujard2, C. Creminon1, C. Guerreiro3, J.F. Delfraissy2, J. Grassi1 and H. Benech1 This was achieved on an ASPEC XL4 (Gilson) for AZT-triphosphate and 3TC-triphosphate. This commercially available benchtop performed the selective extraction of the triphosphate derivatives, addition of the enzyme and incubation at 37C for 3 h, solid-phase extraction of the nucleosides AZT and 3TC and the solvent evaporation within a night. Around 30 unknown samples can be processed in each run. A easy to use EIA, developed in our laboratory, was used for AZT and 3TC quantification. CV% for precision intra- and inter-runs were lower than 20% with an overall extraction yield around 50%. Since no internal standard can be used, quality control samples are included in each series in order to calculate the recovery applicable to the series and to validate the samples. This was successfully applied to patients treated with AZT and 3TC. The methodology can be easily diffused in laboratories which aim to monitor the intracellular production of NRTIs-triphosphate. |
| P263 | DEVELOPMENT AND VALIDATION OF A DIRECT HPLC/MS/MS ASSAY SUITABLE FOR MEASURING INTRACELLULAR PHOSPHORYLATED METABOLITES OF STAVUDINE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P263 AIDS 2000, Oct 22-26;14(Suppl. 4);S91 J. Grassi1, A. Pruvost1, F. Becher1, C. Goujard2, C. Creminon1, P. Clayette3, J.F. Delfraissy2 and H. Benech1 In conclusion, we have developed and validated an LC/MS/MS method which allows the simultaneous determination of mono-, di- and triphosphorylated metabolites of D4T as well as the natural corresponding triphosphate (dT-TP) in a single run. For the first time, the chain terminator ratio (D4T-TP/dT-TP) has been directly measured. The method can be used routinely on a large number of samples per day. Extension to other nucleoside analogues (AZT, 3TC, ddI, ABC) is currently under development. Clinical applications as drug–drug interactions will be performed. |
| P264 | ROUTINE THERAPEUTIC DRUG MONITORING IN PATIENTS ON PROTEASE INHIBITORS: IMPACT ON THERAPEUTIC DECISIONS? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P264 AIDS 2000, Oct 22-26;14(Suppl. 4);S91 S. Ph. Aries1, B.M. Schaaf1, U. Wilmsen1, M. Schuett1 and M. Kurowski2 Even in an unselected patient cohort TDM unveiled suboptimal drug exposure for PIs in more than 50% of the investigated patients and resulted frequently in treatment modification. |
| P265 | PHARMACOKINETICS OF INDINAVIR/DELAVIRDINE 1200/600 MG TWICE DAILY WITH AND WITHOUT FOOD Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P265 AIDS 2000, Oct 22-26;14(Suppl. 4);S92 J.Q. Tran, C. Petersen, M. Garrett, M. Schultz-Smith, J. Escobar, J.H. Lillibridge and B.M. Kerr Relative to IDV 800 mg q8h fasted, all measures of IDV exposure (Cmax, Cmin, AUC) were similar or higher for IDV/DLV 1200/600 mg bid in both the fasted and fed states. Compared to the bid regimen in the fasted state, IDV/DLV bid with food modestly decreased IDV Cmax and increased Cmin. However, this was not statistically significant (P 0.05). DLV exposures (Cmax, Cmin, AUC) for the bid combination regimen with or without food were similar to historical data for DLV 400 mg tid alone. Results from this study suggest that when given concomitantly with DLV 600 mg bid, IDV may be administered as 1200 mg bid without any food restrictions. The clinical efficacy and long-term safety for the combination regimen of IDV/DLV 1200/600 mg bid are currently under investigation. |
| P266 | DELAVIRDINE SIGNIFICANTLY INCREASES PLASMA CONCENTRATIONS OF AMPRENAVIR IN HEALTHY VOLUNTEERS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P266 AIDS 2000, Oct 22-26;14(Suppl. 4);S92 J.Q. Tran, C. Petersen, M. Garrett, M. Schultz-Smith, J.H. Lillibridge, B.M. Kerr. DLV significantly (P < 0.05) inhibited the metabolism of APV, resulting in a 4-fold increase in AUC0-inf and a 6-fold increase in C12h. APV Cmax was modestly increased by 1.3-fold. A single-dose of APV had no significant effect on the steady-state PK of DLV; geometric least squares mean ratios (day 9: day 8) for AUC, Cmax, and Cmin are approximately 1.2, 1.2 and 1.1, respectively. Results from this study suggest that the dose of APV may be reduced when given concomitantly with full-dose DLV. A reduction of APV dosage and pill burden when co-administered with DLV may favorably affect patient adherence. Additional trials are ongoing to determine the optimal dosage regimen. |
| P267 | SERUM AND PLASMA DRUG LEVELS OF AMPRENAVIR DISPLAY LIMITED INTER- AND INTRA-PATIENT VARIABILITY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P267 AIDS 2000, Oct 22-26;14(Suppl. 4);S92 A.D. Luber1,4, S. Gunawan2, S. Lee2, G. Aquino1, P. Chaturvedi3, A. Scarsella4 Serum and plasma trough levels of amprenavir display limited intra-and inter-patient variability. Post 2 h levels display limited intra-patient, but wide inter-patient variability. Given these data, amprenavir may be a good candidate for therapeutic drug level monitoring. |
| P268 | STUDY PROF 1004: STEADY-STATE PHARMACOKINETICS OF AMPRENAVIR 600 MG BID AND RITONAVIR 100 MG BID WITH OR WITHOUT NNRTI IN HIV-1 INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P268 AIDS 2000, Oct 22-26;14(Suppl. 4);S93 C. Goujard1, J.L. Meynard2, N. Choudet1, D. Bollens2, C. Rousseau1, D. Demarles3, I. Vincent1 and A.M. Taburet1 Low dose RTV with or without NNRTI increases APV concentrations even after reducing the APV dose (600 mg bid). |
| P269 | EQUIVALENCE OF PLASMA AND INTRACELLULAR TRIPHOSPHATE LAMIVUDINE PHARMACOKINETICS (PK) FOLLOWING LAMIVUDINE (3TC) 300 MG ONCE DAILY COMPARED TO LAMIVUDINE 150 MG TWICE A DAY IN HEALTHY VOLUNTEERS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P269 AIDS 2000, Oct 22-26;14(Suppl. 4);S93 G.J. Yuen1, Y. Lou2, N.T. Bumgarner1, J. Bishop3, G. Smith3, V. Otto3 and D.D. Hoelscher4 These results demonstrate that 3TC 300 mg once daily is pharmacokinetically equivalent to 3TC administered 150 mg twice daily with respect to plasma AUC24,ss and more importantly the active moiety, intracellular 3TC-TP AUC24,ss and Cmax,ss. There was a trend for trough concentrations to be modestly lower in the 3TC 300 mg once daily regimen (mean difference 18 to 24%). Based on these findings clinical trials to confirm the efficacy and adherence 3TC 300 mg once daily in combination with other antiretroviral to treat HIV infected patients are being progressed. |
| P270 | EVALUATION OF THE QUANTITATIVE LIVER FUNCTION IN HIV POSITIVE PATIENTS WITH ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P270 AIDS 2000, Oct 22-26;14(Suppl. 4);S93 B. Ross, M. Miller, M. Beste, G. Gerken There were no essential differences in the activation of the Cytochrome p450 system in HIV positive patients with coinfections. ART shifts the Cytochrome p450 activity back into standard range. No obvious differences due to various ART combinations (NRTL, NRTI + NNRTI, NRTI + PI) could be observed. |
| P271 | ROLE OF P-GP AND MRP IN CELLULAR INFLUX/EFFLUX OF PROTEASE INHIBITORS IN VITRO Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P271 AIDS 2000, Oct 22-26;14(Suppl. 4);S93 K. Jones1, P.G. Bray1, S.A.Ward1, R.A. Davey2 and D.J. Back1 In CEMVBL cells, the IR and accumulation was reduced for all PIs. In CEME1000 cells there was no change in IR but accumulation was reduced for all PIs. Both GF120918A and verapamil reversed the effect of P-gp in the CEMVBL cells with no effect on control cells. There was no correlation between log D values of the PIs and IR or accumulation at steady state. In conclusion, both P-gp and MRP efflux PIs from cells. However, P-gp also has an effect on the IR. There are marked differences in the intracellular accumulation of the different PIs in vitro. |
| P272 | DECREASED P-GLYCOPROTEIN BUT UNALTERED MULTIDRUG RESISTANCE-ASSOCIATED PROTEIN IN HIV PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P272 AIDS 2000, Oct 22-26;14(Suppl. 4);S94 E.R. Meaden, R.A. Brown, P.G. Hoggard, B. Maher, S.H. Khoo and D.J. Back In HIV infection, P-gp expression in total PBMCs is reduced whereas MRP expression appears to be unaltered. However, it is important to determine (i) if expressed proteins are functional and ii) the distribution of the transporters in different subsets of PBMCs. |
| P273 | THE ROLE OF P-GLYCOPROTEIN IN ORAL BIOAVAILABILITY, BRAIN AND FETAL PENETRATION OF THE HIV PROTEASE INHIBITOR SAQUINAVIR Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P273 AIDS 2000, Oct 22-26;14(Suppl. 4);S94 Maarten T. Huisman1, Johan W. Smit1, Richard M.W. Hoetelmans2, Hugh R. Wiltshire3, Jos H. Beijnen2 and Alfred H. Schinkel1 For saquinavir, penetration into the brain and the fetus was higher in P-gp deficient mice as compared to wild-type mice. These data also indicate that P-gp function results in pharmacological sanctuary sites in brain and testis and low drug penetration into the fetus. Finally, these barriers are not abolished by co-administration of high doses of ritonavir. We are currently investigating the pharmacological effects of more efficient P-gp blockers. |
| P274 | EFFECTS OF RETROVIRAL INFECTION AND ANTI-HIV MOLECULES ON THE EXPRESSION AND ACTIVITY OF P-GLYCOPROTEIN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P274 AIDS 2000, Oct 22-26;14(Suppl. 4);S94 S. Jorajuria1, P. Clayette 1,2, N. Dereuddre-Bosquet 1,2, H. Thiebot1, O. Neildez1, B. Vaslin1, R. Le Grand1 and D. Dormont1 Altogether, these results show that HIV infection modulates in vitro and in vivo the expression and/or activity of P-gp. In contrast, the precise effects of antiretroviral treatments needs further experimentations. In conclusion, P-gp could be disorganised and, in HIV patients, these effects have to be taken to ameliorate the HAART efficiency. |
| P275 | ST JOHN’S WORT MODULATES BOTH EXPRESSION AND FUNCTION OF P GLYCOPROTEIN IN PERIPHERAL BLOOD LYMPHOCYTES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P275 AIDS 2000, Oct 22-26;14(Suppl. 4);S95 M. Hennessy, J. Feely, D. Kelleher, F. Mulcahy and M. Barry Chronic administration of St John’s Wort increases expression of P glycoprotein in healthy volunteers and enhances cellular efflux of Rhodamine. This may partly explain the mechanism by which St John’s Wort reduces plasma concentrations of indinavir. Caution is recommended when St John’s Wort is co-administered with drugs known to be P glycoprotein substrates. |
| P276A | THE PHARMACOKINETIC INTERACTION BETWEEN METHADONE AND NELFINAVIR Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P276A AIDS 2000, Oct 22-26;14(Suppl. 4);S95 S. Clarke1, F. Mulcahy1, C. Bergin1, J. Tjia2, R. Brown2, M. Barry3 and D.J. Back2 Initial data show that when NFV was combined with methadone there was a 55.4% reduction in the mean Cmax and 55.8% reduction in the mean AUC0–24h for methadone, nelfinavir and M8 levels are awaited. Four of the six patients complained of symptoms of methadone withdrawal from day 5–7 onwards, requiring a mean increase in methadone dose of 15%. Unlike other studies, which have shown a significant PK interaction between NFV and methadone but no symptoms of methadone withdrawal [2], this study confirms that a reduction in the plasma concentrations of methadone is associated with symptoms of withdrawal. The most likely pathway for this interaction is induction of glucuronidation, increasing methadone metabolism. |
| P276B | THE PHARMACOKINETICS OF ABACAVIR PHOSPHORYLATION IN PERIPHERAL BLOOBLOOD MONONUCLEAR CELLS FROM HIV POSITIVE PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P276B AIDS 2000, Oct 22-26;14(Suppl. 4);S95 S. Kewn1, B. Maher1, P. Hoggard1, S. Khoo1, P. Carey2, E. Wilkins3, J. Gould4 and D.J. Back1 Since the Ki for inhibition by CBVTP of incorporation of dGTP into DNA by HIV-1 RT has been reported to be 21 nmol/l these new data point to an above inhibitory level of CBVTP within the cell over 24 h (50 fmoles/ 106cells = 100 nmol/l). |
| P277 | PHARMACOKINETICS (PK) INTERACTIONS BETWEEN NELFINAVIR (NFV) AND CALCIUM SUPPLEMENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P277 AIDS 2000, Oct 22-26;14(Suppl. 4);S96 B. Kopp Hutzler1, E. Perez-Rodriguez2, S. Norton1 and P.H. Hsyu1 None of the concentrations were significantly different (P > 0.05) between the Oscal and generic calcium groups. The concentrations were also very similar to those from a previous study (historic control) in HIV patients taking NFV 1250 mg bid in combination with 3TC and d4T. NFV combined with calcium was well tolerated. Oral calcium preparations including Oscal and other preparations did not change the systemic exposure of NFV. Calcium supplements remain an effective means of reducing NFV-induced diarrhea. |
| P278 | A PHARMACOKINETIC STUDY OF INDINAVIR (IDV) 600 MG BD AND RITONAVIR (RTV) 200 MG BD IN PLASMA AND SEMEN OF HIV-1 INFECTED MEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P278 AIDS 2000, Oct 22-26;14(Suppl. 4);S96 S. Taylor1,3, H. Reynolds2, S.M. Drake3, C. Stradling3, D.J. White, S.E. Gibbons2, and D.J. Back2 In this study [IDV] concentrations were well above the MEC of 100 ng/ml at all times. Interestingly [RTV]s were above the MEC of 2100 ng/ml for approximately 1/2 of the dosing period. 4/6 patients had BPVL < 50 c/ml and 6/6 had SPVL<400c/ml at 24 weeks. |
| P279 | CONCENTRATION OF STAVUDINE IN BLOOD AND SEMEN FROM HIV-1 INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P279 AIDS 2000, Oct 22-26;14(Suppl. 4);S96 G. Liuzzi, A. Chirianni1, R. Casazza2, A. Tallarino3 and M. Piazza3 The results should encourage further studies of the penetration of antiviral drugs in semen and the development of strategies to determine whether antiviral drugs can be used to reduce the sexual transmission of HIV-1. |
| P280 | DECREASED ACTIVITY OF THE ENZYME CYP2C9 DOES NOT PROTECT AGAINST SULPHONAMIDE HYPERSENSITIVITY IN HIV POSITIVE PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P280 AIDS 2000, Oct 22-26;14(Suppl. 4);S97 A.C. Stalford1, F.J. Vilar1,2, A. Alfirevic1, E.G.L. Wilkins2, M. Pirmohamed1 and B.K. Park1 Our results show that either a pharmacologically-mediated (by the use of fluconazole) or a genetically determined (through the presence of functional polymorphisms) decrease in the activity of CYP2C9 does not protect against TMP-SMX hypersensitivity in HIV-positive patients. |
| P281 | PLASMA SAQUINAVIR CONCENTRATIONS REMAIN STABLE DURING LONG-TERM TREATMENT: ANALYSIS OF 36 ADULT PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P281 AIDS 2000, Oct 22-26;14(Suppl. 4);S97 C. Farthing, C. Oo1, A. Hill1, K. Jorga1 and H. Stirnadel1 Saquinavir concentrations remained stable throughout a 60 week period of treatment in an intensive PK substudy of the TIDBID trial. Analyses correlating plasma drug levels with HIV RNA reductions will be presented. |
| P282 | INTRACELLULAR INDINAVIR PHARMACOKINETICS IN HIV POSITIVE PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P282 AIDS 2000, Oct 22-26;14(Suppl. 4);S97 M. Hennessy1, S. Clarke2, F. Mulcahy2, C. Bergin2, J. Tjia3, D. Back3 and M. Barry1 In agreement with published in-vitro data indinavir does not undergo significant intracellular accumulation within the lymphocytes of HIV infected patients [2]. However the intracellular time to peak is delayed, and the mean residence time of indinavir within the cell and the intracellular half life prolonged. This may in part explain why certain patients maintain adequate viral suppression despite sub-therapeutic plasma indinavir concentrations. |
| P283 | ENHANCEMENT OF PHARMACOKINETIC PARAMETERS OF AMPRENAVIR WHEN COMBINED WITH LOW DOSE RITONAVIR (APV 600 MG/RTV 100 MG BID) AND PRELIMINARY EFFICACY RESULTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P283 AIDS 2000, Oct 22-26;14(Suppl. 4);S98 R. Wood1, C. Trepo2, J.M. Livrozet3, K. Arasteh4, J. Eron5, P. Kaur6, O. Naderer and M.B. Wire7 In conclusion, the addition of low dose rtv (100 mg bid) to an APV containing regimen allows reduction of the total daily dose of APV (from 16 to 8 capsules daily) with improved pharmacokinetic parameters and maintained virologic suppression. |
| P284 | MULTIPLE-DOSE PHARMACOKINETICS (PK) AND TOLERABILITY OF INDINAVIR (IDV) WITH RITONAVIR (RTV) AND EFAVIRENZ (EFV) COMBINATIONS IN A ONCE-DAILY REGIMEN IN HEALTHY VOLUNTEERS (MERCK 093) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P284 AIDS 2000, Oct 22-26;14(Suppl. 4);S98 A. Saah, G. Winchell, R. Rhodes, M. Nessly and P. Deutsch In this study, all qd regimens with efavirenz produced IDV PK profiles that were less than the PK profiles of the qd regimens without efavirenz and were also less than standard IDV 800 mg q8h, which the IDV/RTV 1200/100 combination from Merck 089 approximated. The IDV PK profile observed at 12 h, however, support further research in twice-daily IDV/RTV with EFV qd. The regimens were generally well-tolerated. |
| P285 | LIMITED TRANSPORT OF THE HIV-1 PROTEASE INHIBITOR, INDINAVIR, ACROSS THE BLOOD–BRAIN BARRIER: IN VIVO–IN VITRO CORRELATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P285 AIDS 2000, Oct 22-26;14(Suppl. 4);S98 A. Mabondzou1, I. Mégard1, A. Garrigues2 and S. Orlowski2 In conclusion, in vitro results are in agreement with in vivo data regarding brain-to-plasma ratio after intravenous injection of radiolabelled indinavir into mice. All those experimental systems confirmed the limited low transport of indinavir within the CNS, and the potential role of P-gp in, preventing therapeutic agents from being effective within the CNS where viral replication takes place. |
| P286 | PHARMACODYNAMICS OF LOW DOSES RITONAVIR/AMPRENAVIR COMBINATION IN A SALVAGE REGIMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P286 AIDS 2000, Oct 22-26;14(Suppl. 4);S98 L. El-Hajj1, G. Peytavin2, F. Bani-Sadr1, J. Salomon1, D. Mathez1 and P. deTruchis1 The combination of low doses RTV/APV in heavily pretreated patients with resistant viruses was well tolerated and associated with a substantial response on VL (–1.68 log). Cmin values of APV were increased by RTV, sometimes overcoming multiple-drug resistance. |
| P287 | DISCREPANCIES BETWEEN DRUG NOTATIONS IN MEDICAL RECORDS AND PUBLIC PHARMACY RECORDS IN A COHORT OF HIV-1-INFECTED INDIVIDUALS: A POTENTIAL FOR DRUG–DRUG INTERACTIONS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P287 AIDS 2000, Oct 22-26;14(Suppl. 4);S99 M.M.R. de Maat, S.V. Frankfort, R.A.A. Mathôt, J.W. Mulder, P.L. Meenhorst, E.C.M. van Gorp, J.H. Beijnen, A. de Boer and R.M.W. Hoetelmans The observed discrepancies between medical records in the hospital and public pharmacy records (53.0%) mainly concern the comedication (91.3%). For the antiretroviral drugs less, but substantial, discrepancies were observed (up to 17.0%). A better communication between general practitioners, specialists, public pharmacies and patients may potentially improve the care and treatment of HIV-1-infected patients by the prevention of undesirable drug-drug interactions. |
| P288 | THE STEADY-STATE PHARMACOKINETICS OF SAQUINAVIR (SQV-SGC, FORTOVASE™) 1000 MG BID IN COMBINATION WITH RITONAVIR (RIT) 100 MG BID IN HIV-1-INFECTED INDIVIDUALS AFTER A NORMAL AND A HIGH-FAT BREAKFAST Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P288 AIDS 2000, Oct 22-26;14(Suppl. 4);S99 A.I. Veldkamp1, R.P.G. van Heeswijk, J.W. Mulder, P.L. Meenhorst, G. Schreij, S. van der Geest, J.H. Beijnen, J.M.A. Lange and R.M.W. Hoetelmans The combination of SQV-SGC 1000 mg bid and RIT 100 mg bid resulted in adequate exposure to SQV, after ingestion with either a normal or a high-fat breakfast. There was a non-significant trend of higher exposure to SQV when administered with a high-fat breakfast as compared to a normal breakfast. |
| P289 | ENHANCING SAQUINAVIR LEVELS BY UTILISING NOVEL ANTIRETROVIRALS AS CYTOCHROME P450 INHIBITORS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P289 AIDS 2000, Oct 22-26;14(Suppl. 4);S99 G. Hales1, N. Roth2, M. Law1 and D. Smith1 on behalf of the CHRN 025 Investigator Group Seventy-five patients were randomised into the study, of whom 73 started study medication. 96% were male with a mean age of 41. Mean baseline CD4+ cell count was 402 cells/mm³ and mean HIV plasma viral load was 3.71 log copies/ml, 21% of patients had a HIV plasma viral load < 500 copies/ml. In all groups there was a significant CD4+ cell counts increase (P < 0.01) and HIV viral load decrease (P < 0.02) from baseline to week 52. There were no significant differences between groups. The percentage of people with undetectable viral load had increased to 51% at week 52. Baseline saquinavir resistance (P = 0.03), higher HIV plasma viral load (P = 0.04) and younger age (P = 0.007) were associated with increased risk of treatment failure. |
| P290 | ANTIVIRAL EFFICACY AND EFFECTS OF PROTEIN BINDING FOR HIV PROTEINASE (PR) INHIBITORS (PI) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P290 AIDS 2000, Oct 22-26;14(Suppl. 4);S100 C. Craig, J. Rose, J. Haywood, A. Kohli, B. Sutton and N. Cammack IC50 (and IC90) of both drugs were consistently increased against WT virus similarly in the presence of HS. ABT and SQV were highly protein bound in FBS and HS. Despite this, they showed high potency (IC50 and IC90) against WT virus. However, serum supplementation of media underestimated the effect of ABT binding to AAG at physiological concentrations, which was 5- fold greater with ABT than with SQV at 1 mg/ml. In addition, SQV showed substantially more activity against viruses with the 82/84 IDV/RTVassociated mutations and similar activity to the virus with 90M compared to ABT. SQV was relatively less potent only in tests against the rare, SQV-specific 48/90 mutant combination. However, AAG-correction suggests similar IC50 to ABT in vivo. Different antiviral activity under these conditions suggests that even small differences in the concentration of free drug can be significant at the antiviral level and direct measurement of effect is essential. However, antiviral activity in media supplemented with HS alone might mislead. These projections also suggest a requirement for much higher plasma levels of ABT than SQV in salvage. |
| P291 | PHARMACOKINETIC INTERACTIONS BETWEEN LOPINAVIR/RITONAVIR (ABT-378R) AND OTHER NON-HIV DRUGS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P291 AIDS 2000, Oct 22-26;14(Suppl. 4);S100 R. Bertz, A. Hsu, W. Lam, L. Williams, C. Renz, M. Karol, S. Dutta, R. Carr, Y. Zhang, Q. Wang, S. Schweitzer, C. Foit, A. Andre, B. Bernstein, G.R. Granneman and E. Sun In vivo, ABT-378/r inhibits CYP3A-mediated clearance of ketoconazole, atorvastatin and rifabutin, and is a metabolic inducer of methadone and ethinyl estradiol. ABT-378 is susceptible to induction by rifampin, but not by rifabutin. ABT-378 is not susceptible to CYP3A inhibition by ketoconazole. |
| P292 | ASSESSMENT OF THE PHARMACOKINETIC INTERACTION BETWEEN LOPINAVIR/RITONAVIR (ABT-378/R) AND NEVIRAPINE (NVP) IN HIV-INFECTED PEDIATRIC SUBJECTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P292 AIDS 2000, Oct 22-26;14(Suppl. 4);S100 A. Hsu, R. Bertz, C. Renz, W. Lam, R. Rode, C. Deetz, S.M. Schweitzer, B. Berstein, S. Brun, G.R. Granneman and E. Sun Similar effects were observed for ritonavir. The dose of 300/75 mg/m2 BID yields ABT-378 concentrations similar to (with NVP) or slightly higher than (without NVP) concentrations in adults receiving 400/100 mg bid. A similar NVP effect may be present in adults receiving ABT-378/r and may warrant dose increase of ABT-378/r (to 4 capsules bid) in patients with substantially reduced ABT-378 susceptibility. |
| P293 | PLASMA LEVELS OF PROTEASE INHIBITORS, PATIENT REPORTED SYMPTOMS AND REGIMEN DISCONTINUATIONS DUE TO TOXICITY IN A COHORT OF HIV-INFECTED INDIVIDUALS ON HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P293 AIDS 2000, Oct 22-26;14(Suppl. 4);S101 A. De Luca1, A. Ammassari1, R. Murri1, K. Gallicano3, P. Marconi1, F. Baldini1, A. Cingolani1, S. Di Giambenedetto1, M.P. Trotta2 and A. Antinori2 Preliminary analysis shows that higher plasma Cmin of PI are associated with higher probabilities of concomitant patient-reported symptoms and of subsequent treatment discontinuation due to toxicity. |
| P294 | ERADICATION OF MULTIDRUG RESISTANT (MDR) PSEUDOMONAS BACTEREMIA UTILIZING CONTINUOUS INFUSION PIPERACILLIN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P294 AIDS 2000, Oct 22-26;14(Suppl. 4);S101 F. Cruickshank1, J. Chen2 and M. Robinson3 Continuous infusion is a viable inexpensive method of eradicating life-threatening infections in patients with compromised host defenses. Piperacillin continuous infusion can be utilized in severely ill HIV positive patients to eradicate MDR Pseudomonas aeruginosa bacteremia, improve fevers and other markers of infection and result in clinical cure. |
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9 PHARMACOECONOMICS Abstracts P295 thru P304, Pages S101 TO S104 |
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| P295 | DETERMINING THE COST OF HOSPITALISATION OF HIV-INFECTED PATIENTS IN IRELAND IN ORDER TO ASSESS THE PHARMACOECONOMIC IMPACT OF HAART ON INPATIENT CARE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P295 AIDS 2000, Oct 22-26;14(Suppl. 4);S101 M. Ryan, C. Merry, C. Ryan, A. Heerey, B. McGowan, F. Mulcahy and M. Barry St James’s Hospital, Dublin, Ireland In the microcosting study an inverse relationship between the baseline CD4 count and both the cost per day and the cost per admission was noted. The marked reduction in the mean cost of hospitalisation from 1995 to 1998 was largely attributable to decreased number of inpatient days. This may be explained by the fact that ward costs account for on average 58.8% of the cost of inpatient care for HIV infected patients. Therefore any intervention e.g. HAART that results in a notable decrease in the number of inpatient days is associated with a substantial pharmacoeconomic impact. |
| P296 | COSTS OF CARE FOR HIV-1 INFECTED PATIENTS CHANGE WITH CHANGES IN VIRAL LOAD Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P296 AIDS 2000, Oct 22-26;14(Suppl. 4);S102 C. Holtzer1, E. Hamel2, C. De Guzman2, D. Lapins2 Abstract not reproduced at Author’s request |
| P297 | DRUG WASTAGE IN A CENTRAL LONDON HIV TREATMENT CENTRE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P297 AIDS 2000, Oct 22-26;14(Suppl. 4);S102 F. Burns1, J. Minton2, A. McOwan2, R. Heylan2, I.G. Williams1,4 and M.R. Pakianathan1 The overall increase in the cost of wastage reflects the vast increase in the use and cost of antiretrovirals. However, a reduction in percentage cost wasted was achieved. Our change in prescribing policy of giving shorter prescriptions at the initiation of any change in therapy was successful in reducing the financial burden of drug wastage. |
| P298 | QUANTIFICATION OF THE RELATIONSHIP BETWEEN EXPENDITURE ON ANTIRETROVIRAL THERAPY AND INCREASE IN CD4 CELL COUNT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P298 AIDS 2000, Oct 22-26;14(Suppl. 4);S102 M. Ryan, C. Merry, P. Harrington, F. Mulcahy, M. Barry M.R. Pakianathan1 Abstract not reproduced at Author’s request |
| P299 | THE COST EFFECTIVENESS OF ADHERENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P299 AIDS 2000, Oct 22-26;14(Suppl. 4);S102 T.L. Kauf and J. Jordan Considering the likely impact of adherence on disease progression and total (direct) health care cost, even small improvements in adherence can be cost-effective from a payer’s perspective. We did not examine the cost of achieving improved adherence. However, simple opportunities to enhance adherence, such as prescribing compact regimens, have the potential to generate cost-savings for payers. |
| P300 | A DECISION TREE MODEL COMPARING 6-MONTH COSTS OF LOPINAVIR/R VERSUS NELFINAVIR THERAPY USING CLINICAL TRIAL DATA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P300 AIDS 2000, Oct 22-26;14(Suppl. 4);S102 M. Luo, R. Boggs, E. Sun and T. Ashraf In the base case, lopinavir/r showed more therapeutic responders than nelfinavir for the first 6 months of therapy. This clinical benefit translated to a potential cost savings of $342 per patient/6 months. If the definition of therapeutic failure was set at > 1,000, 5,000 or 10,000 copies/ml, cost savings still remained at $226, $125, and $103, respectively. When the regimen for therapeutic failures was changed to PI+NNRTI+2NRTIs, 2PI+NNRTI+2NRTIs, PI+2NRTIs, or NNRTI+2NRTIs, the estimated 6-month cost savings per patient was $271, $459, $154, and $84, respectively. Under a wide range of clinical assumptions, this study suggests that lopinavir/r has the potential to reduce total HIV health care costs for treating antiretroviral naïve HIV patients when compared with nelfinavir in the first 6 months of therapy. The model will be customized for the UK, France, Germany, Italy, Spain and the Netherlands, and comparative data will be presented. |
| P301 | ECONOMIC COMPARISON OF LOPINAVIR/R VERSUS NELFINAVIR IN COMBINATION WITH 3TC AND D4T IN ARV-NAÏVE PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P301 AIDS 2000, Oct 22-26;14(Suppl. 4);S103 K.N. Simpson, E.O. Voit, R. Goodman, T. Ashraf, J. Hutton, E. Sun The long-term value of starting HAART with a regimen containing LOP appears to meet the cost effectiveness threshold for the US based on a predicted effectiveness ratio of US$18 899 per QALY in favor of LOP. Studies are underway to assess the implications for other developed countries, using local cost data and treatment modifications to reflect practice differences. We expect to report on the model results with UK data and assumptions, in addition to US results. |
| P302 | THE RELATION OF CD4 COUNT AND VIRAL LOAD TO QUALITY OF LIFE AND RESOURCE UTILIZATION IN THE HIV COST AND SERVICES UTILIZATION STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P302 AIDS 2000, Oct 22-26;14(Suppl. 4);S103 R. Boggs and T. Ashraf HCSUS data imply that higher CD4 counts and lower viral loads are each independently associated with better QoL. For resource utilization, HCSUS data indicate that high CD4 counts are associated with low treatment costs. |
| P303 | THE EFFECT OF PIS ON QUALITY OF LIFE AND RESOURCE UTILIZATION IN THE HIV COST AND SERVICES UTILIZATION STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P303 AIDS 2000, Oct 22-26;14(Suppl. 4);S103 R. Boggs and T. Ashraf HCSUS data offer no support for the claim that PIs affect QoL (when controling for CD4 count and viral load). The data do show a relationship between PIs, NNRTIs and higher non-drug treatment costs. PIs show more durability than other ART classes. |
| P304 | COST EFFECTIVENESS OF ABACAVIR + COMBIVIR TRIPLE NUCLEOSIDE THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P304 AIDS 2000, Oct 22-26;14(Suppl. 4);S103 T.L. Kauf1, J. Jordan1, C. Pharo2, R. Athisegaran2 and N. Thomas2 The results of this trial, in conjunction with the economic model suggest that a triple nucleoside combination of ABC + COM is cost-effective compared to IDV + COM. Treatment options that promote adherence have the potential to improve clinical response and generate cost-savings. |
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10.1 GENERAL VIROLOGY Abstracts P305 thru P322, Pages S104 TO S110 |
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| P305A | DETERMINATION OF HIV-1 CIRCULAR DNA AS A SURROGATE MARKER FOR RESIDUAL VIRAL REPLICATION IN PATIENTS WITH SUPPRESSED PLASMA VIREMIA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P305A AIDS 2000, Oct 22-26;14(Suppl. 4);S104 I. Hauber1,2, P. Löw3, M. Schmitt3, E. Schwingel2, J. Hauber2 and T. Harrer3 In the majority of patients the current drug regimens are not able to block completely viral replication in the peripheral blood. The analysis of 1-LTR and/or 2-LTR DNA circles is a powerful technique for the sensitive monitoring of residual viral replication in patients with undetectable plasma viral load that may facilitate the development of more potent drug combinations. |
| P305B | LONGITUDINAL VIROLOGICAL FOLLOW-UP OF 31 ANTIRETROVIRAL THERAPY NAÏVE ADULTS INITIATING QUADRUPLE THERAPY WITH COMBIVIR, ABACAVIR AND EFAVIRENZ (CNAF3008) USING A BOOSTED HIV-1 RNA ASSAY WITH A LOWER DETECTION LIMIT OF 5 COPIES/ML Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P305B AIDS 2000, Oct 22-26;14(Suppl. 4);S104 A. Rakik1, P. de Truchis2, G. Force3, Y. Welker4, D. Mechali5, M. Pulik6, K. Chemlal7, E. Rouveix8, A. Devidas9, D. Praindhui10, J.P. Mamet10 and M. Ait-Khaled1 The time to lowest median vRNA was week 4, week 8 and week 24 for the standard, ultrasensitive and boosted assays respectively. Furthermore, at week 48, the boosted assay appears to show a difference in efficacy based on vRNA at study entry. The percentage of patients with week 48 vRNA < 5 copies/ml was 36% and 38% for > 100,000 copies/ml and 69% and 67% for > 100,000 copies/ml by AT and ITT analyses, respectively. This data demonstrates that time to maximal measurable viral suppression at the 5 copies/ml level, after initiation of a quadruple EFV-containing HAART, is dependent on baseline vRNA. Longer follow-up is required to determine if maximal suppression is eventually achieved for patients with the highest baseline vRNA. |
| P306 | ANTIRETROVIRAL THERAPY IN HIV-2 INFECTED PATIENTS IN THE NETHERLANDS: RESULTS IN 17 PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P306 AIDS 2000, Oct 22-26;14(Suppl. 4);S104 M.E. van der Ende1, K. Brinkman2, M. Keuters3, J.M. Prins4, S.A. Danner4, A.D.M.E. Osterhaus1 and M. Schutten1 The efficacy of ART in HIV-2 infected patients depends on the compounds of the regimen. |
| P307 | EVALUATION OF VIDAS HIV DUO ULTRA: A NEW HIV SCREENING TEST COMBINING BOTH DETECTION OF P24 ANTIGEN AND THE HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P307 AIDS 2000, Oct 22-26;14(Suppl. 4);S105 T.D. Ly1 and E. Brignoli2 The newer 4th generation test, VIDAS HIV DUO Ultra, exhibited superior detection of HIV infection resulting in a reduction of the seroconversion phase of infection. Its specificity was found to be 99.83% in 2400 blood donor samples and 99.65% with 2002 clinical samples. In several seroconversion panels tested, the new HIV Ultra 4th generation test was shown to have a detection limit similar to most of the antigen assays currently available today. This test could be useful for routine HIV screening, especially in cases of primary infection where other screening tests might give false negative results. |
| P308 | EVALUATION OF A FULLY AUTOMATED, FOURTH GENERATION IMMUNOASSAY FOR THE SIMULTANEOUS DETECTION OF HIV ANTIGEN AND ANTIBODY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P308 AIDS 2000, Oct 22-26;14(Suppl. 4);S105 N.T. Constantine, R.D. Saville, M. Sobus, F.R. Cleghorn, N. Jack, C. Bartholomew, J. Edwards and W.A. Blattner The assay demonstrated 100% sensitivity and 99.4% specificity overall, with a 99.7% specificity in low risk individuals. The analytical sensitivity of the test for detecting early infection, as assessed by seroconversion panels and p24 antigen in the samples from different HIV-1 clades, was equivalent to or better than assays used in the characterization of these panels. We conclude that the VIDAS HIV DUO Ultra performed excellently, offers several advantages over conventional HIV testing including time and cost savings, and is more sensitive than HIV antibody assays for detecting early infection so that intervention therapy can be initiated quickly. |
| P309 | THE DIAGNOSIS OF TWO CASES OF HIV ACUTE SEROCONVERSION ILLNESS USING THE VIDAS DUO TEST Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P309 AIDS 2000, Oct 22-26;14(Suppl. 4);S105 S.L. Lacey and S. Sampson After institution of antiretroviral therapy, confirmation by HIV–RT–PCR was performed. As a consequence of these results, it is recommended that the Vidas HIV DUO test be utilised as a routine screen for HIV where acute seroconversion illness is suspected where this test appears more reliable than routine serology. |
| P310 | ASSESSMENT OF A HIV INFECTION SCREENING TEST VIDAS HIV DUO Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P310 AIDS 2000, Oct 22-26;14(Suppl. 4);S105 A. Fernández and A. González When compared with other reactives for ag p24 detection, sensitivity of HIV DUO is 100%. When presence of infection is the pattern used, sensitivity is 98% The infection is diagnosed an average of 6–7 days earlier in relation to those test which detect antibodies The limit of detection of p24 antigen was 18 pgr/cc. Specificity: 100% in negative samples; 98.5 % in samples with inespecific reactivity. Negative samples show test value distant from cut-off value, which indicates that negative is properly discriminated. Precision: CV value was > 10% for both standard and control LSP. Test efficiency determined for HIV DUO test was 90%. |
| P311 | DIFFERENT PATTERNS OF EVOLUTION IN A HETEROSEXUAL TRANSMISSION CASE IN RESPONSE TO LONG-TERM THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P311 AIDS 2000, Oct 22-26;14(Suppl. 4);S106 C. Anastassopoulou1, D. Paraskevis1, A. Antoniadou2, H. Giamarelou2, V. Sypsa1 and A. Hatzakis1 These results are in agreement with the notion that the evolutionary dynamics exhibited by HIV-1 quasispecies, even of the same strain, are host-dependent and compatible with adaptive evolution within the unique immunological milieu of each patient. Such considerations of genomic fluctuations in time and space in response to therapy are important parameters that may influence its long-term efficacy. |
| P312 | A SIGNIFICANT NUMBER OF UNINFECTED INFANTS CAN BE HIV RNA (FALSE) POS-POSITIVE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P312 AIDS 2000, Oct 22-26;14(Suppl. 4);S106 C.M. Stainsby1, E.G.H. Lyall2, G.P. Taylor1, S. Galpin1, J.R. Clarke1, M.O. McClure1 and J.N. Weber1 12/138 and 11/138 samples tested positive for HIV RNA, using the ST CV of 1000 µl and 250 µl respectively. Only two of these results were true positives with much higher copy number. Only 1/18 samples from infants with paired samples was HIV positive. This high false positive rate of HIV-RNA testing in infant plasma has implications not only for infants and parents who may be given erroneous results, but also for low positive HIV-RNA levels in patients on treatment with ‘viral rebound’ as well as those under investigation for acute seroconversion. |
| P313 | CLINICAL RELEVANCE OF PROVIRAL HIV DNA QUANTITATION IN PBMC AND LYMPH NODE CELLS OF PATIENTS ON EFFECTIVE HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P313 AIDS 2000, Oct 22-26;14(Suppl. 4);S106 A. Lafeuillade1, H. Khiri2, C. Solas3, S. Chadapaud1, G. Hittinger1, B. Lacarelle3 and P. Halfon2 Despite effective control of HIV-1 replication with HAART, proviral HIV-1 DNA remains detectable in blood and lymphoid tissue of all the patients studied. In most cases, but not all, levels were higher in LNMC than in PBMC. As no correlation was found between these reservoirs, viral evaluation in blood remains a crude estimate of HIV-1 burden in treated patients. This is of clinical relevance for future therapeutic strategies testing the possibility to obtain viral eradication or remission. |
| P314 | PROVIRAL HIV-DNA DECLINE AFTER 2 YEARS OF THERAPY IN EARLY PHASE OF INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P314 AIDS 2000, Oct 22-26;14(Suppl. 4);S107 S. Parisi1, L. Sarmati2, R. Mazzi1, A. Angheben1, F. Gatti1, E. Nicastri2, E. Concia1 and M. Andreoni2 A long term therapy (over 24 months) in patients in early phase of infection produces a stable and progressive immune restoration, and maintains HIV-RNA copies under the detection limit with few compliance failures. The treatment seems not sufficient to produce a complete HIV-DNA clearance from PBMC, but is possible that determines a mild improving trend. |
| P315 | PERIPHERAL BLOOD MONONUCLEAR CELL-DERIVED VIRAL LOAD IN HIV SEROPOSITIVE PATIENTS MAY REFLECT LATENT HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P315 AIDS 2000, Oct 22-26;14(Suppl. 4);S107 N. Vardinon1, I. Yust1, P. van der Weil2, Y. Sela1, B. Tartakovsky1, I. Zeldis1 and M. Burke1 In conclusion, in HIV seropositive patients, at higher plasma viral loads, there is a good correlation between the plasma and PBMC-derived viral loads. Yet, at undetectable plasma viral load levels, the correlation is poor, and HIV–RNA is frequently detected in PBMCs. This difference may be due to the presence of a sub-population of latently infected PBMCs, which have not released the HIV virions into the plasma. This test may prove to be useful in the follow up of patients. |
| P316 | MULTICENTER STUDY OF A NOVEL POL-BASED CRT-PCR FOR THE MEASUREMENT OF CLADE B HIV-1 RNA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P316 AIDS 2000, Oct 22-26;14(Suppl. 4);S108 H. Troonen, H. Grey, G. Michel for the LCx HIV RNA Quantitative Assay Multicenter Study Group Overall average viral load differences were log10 copy/ml (95% CI) –0.192 (–0.244 to –0.140), –0.367 (–0.394 to –0.316), –0.361 (–0.394 to –0.328), –0.230 (–0.284 to –0.177) versus Amplicor v1.5, Cobas Amplicor, bDNA 3.0, and NucliSens 2.0, respectively. Not unexpected, differences were most pronounced in the 50–500 copies/ml stratum while remaining < 0.5 log versus Amplicor 1.5: –0.377 (–0.482 to –0.273), –0.614 (–0.703 to –0.524), – 0.432 (–0.507 to –0.356), –0.878 (–1.164 to –0.591). Differences computed on viral load strata . 500 copies/ml were uniformly < 0.5 log. In conclusion, LCx HIV generally produced increased viral levels. Assay agreement, except for viral loads < 500 copies/ml, was better than 0.5 log. Pol-region based LCx HIV RNA QT correlates and agrees strongly with gag-region based target and pol-region based signal amplified pVL tests for assay of clade B HIV-1 RNA. |
| P317 | DEVELOPMENT OF A QUANTITATIVE ASSAY FOR HIV-1 RNA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P317 AIDS 2000, Oct 22-26;14(Suppl. 4);S108 P.M. MacLean1, P.J. Levasseur1, B. Weinbaum2, J.M. McCarty1, J.L. Burg1 The VIDAS PROBE format under development should prove a useful tool for determining HIV-1 viral load in infected patients. |
| P318 | DETECTION OF PRIMARY HIV INFECTIONS WITH A FOURTH GENERATION TEST Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P318 AIDS 2000, Oct 22-26;14(Suppl. 4);S108 R. Ortiz de Lejarazu, M. Ortega, B. Hernández, J.M. Eiros, C. Labayru and A. Rodríguez-Torres New 4th GT allow an earlier diagnosis of HIV. Therefore, we can reduce the risk of missing any unsuspected primary HIV infections in routine testing infection (2.9% over total positive test). Confirmation of primary HIV infection can be obtained by either p24 Ag and/or PCR. Use of 4th GT may facilitate early HIV therapy and avoiding new infections during the silent ‘window period’. |
| P319 | CSF HIV-1 RNA IN A COHORT OF HEMOPHILIC PATIENTS HIV POSITIVE TREATED WITH HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P319 AIDS 2000, Oct 22-26;14(Suppl. 4);S109 M.E. Corti, M.F. Villafañe, M. Tezanos Pinto, R. Perez Bianco, P. Bare, F. Alves Rosa and G. Picchio In this study, antiretroviral therapy that includes 2 NRTI plus 1 PI or 2 NRTI plus 1 NNRTI was linked to a significant effect on CSF viral load related to reduction of RNA HIV-1 plasma levels in patients without neurocognitive involvement. In patients with detectable levels of plasma viral load, our results confirm previous reports that there is no correlation between plasma viral load and CFS viral load. These data are a strong argument in favor of local production of HIV-1. Viral load is usually lower in non blood fluids and HAART decrease viral load in CSF much as it does in blood. |
| P320 | ARE COMBINED ELISA AND SIMPLE/RAPID TESTS ALONE ADEQUATE FOR THE DIAGNOSIS OF HIV INFECTION? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P320 AIDS 2000, Oct 22-26;14(Suppl. 4);S109 Michael Burke1, Nurit Vardinon1, Zehava Grossman2, Dan Turner1, Irena Zeldis1, Elizabeth Mardkah1, Yaffa Shlomo-David2, Ella Mendelson2 and Israel Yust1 In conclusion, high false positive ELISA values are found more frequently in various infections and tumors. Further, although ELISA and rapid test are very useful in the diagnosis of HIV infection, they should not be used as the only criteria. Western blot still remains the confirmatory test in low prevalence countries such as Israel. |
| P321 | CHARACTERIZATION OF HIV-1 NON-B SUBTYPES PREVALENT IN A POPULATION ATTENDING A LONDON HIV/AIDS OUTPATIENTS CLINIC Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P321 AIDS 2000, Oct 22-26;14(Suppl. 4);S109 Fionna van Hooff, C. Loveday, A. Burke and M. Johnson1 Serological methods are a useful tool in screening patients for the presence of either B or non-B viruses, but not identifying specific subtypes. The latter requires molecular techniques for more specific subtype characterization. Our work continues as we identify and study recombinant and divergent viruses and their effects as part of a larger epidemiological/clinical program with the Royal Free non-B population. |
| P322 | INCREASE OF VIROLOGICAL CONTROL IN PATIENTS WITH HIV-1 INFECTION BETWEEN 1996 AND 2000 Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P322 AIDS 2000, Oct 22-26;14(Suppl. 4);S109 Joanne Page1, Andy Burke1, Margaret A. Johnson2 and Clive Loveday1 In the last 4 years we have noted a significant increase in the proportion of samples with undetectable plasma HIV-1 RNA loads. This change reflects an increase in virological control with new drug combinations. However, only half of the samples currently fall into this group, emphasising the need for vigilance in relation to the lack of this long-term patient virological control. |
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10.2 RESISTANCE Abstracts P323 thru P366, Pages S110 TO S123 |
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| P323 | VIRAL RESISTANCE PROFILE AT VIROLOGICAL FAILURE FOLLOWING SWITCH FROM A PROTEASE INHIBITOR TO A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR AMONG PATIENTS WITH UNDETECTABLE HIV-1 RNA: EMERGENCE OF ARCHIVED RESISTANCE VIRUSES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P323 AIDS 2000, Oct 22-26;14(Suppl. 4);S110 F. Raffi1, V. Ferre2, J.L. Esnault1, B. Bonnet1, V. Guiilard2, S. Rogez3 and S. Billaudel2 Virological failure, in patients with undetectable HIV-1 RNA on PI treatment who are switched to a NNRTI, can arise from archived viruses with RT resistance mutations selected by prior mono or dual NRTI therapy. Pre-existing NNRTI mutations in NNRTI-naïve patients can account for viral breakthrough after PI–NNRTI switch and stresses the need for baseline genotype characterisation to provide an optimal strategy for sequencing antiretroviral treatment. |
| P324 | SUSTAINED IMMUNOLOGICAL AND VIROLOGICAL RESPONSE AFTER 2 YEARS OF TRIPLE NUCLEOSIDE THERAPY WITH ABC/3TC/ZDV IN HIV-1 INFECTED PATIENTS PRETREATED WITH 3TC/ZDV (CNA3009) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P324 AIDS 2000, Oct 22-26;14(Suppl. 4);S110 W. Rozenbaum1, C. Katlama2, M. Bentata3, J.P. Mamet4, F. David4, R. Lanier5 In this open-label study, HIV-1 infected pts experienced longterm control of viral replication and immune response while receiving ABC/ 3TC/ZDV therapy. The presence of M184V RT mutation alone did not impact this response. |
| P325 | LACK OF RESISTANCE TO ABT-378/RITONAVIR (ABT-378/R) OBSERVED AFTER 24 WEEKS OF THERAPY IN ANTIRETROVIRAL NAÏVE SUBJECTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P325 AIDS 2000, Oct 22-26;14(Suppl. 4);S110 B. Bernstein, D. Kempf, J. Moseley, M. Sattler, M. King, C. Renz, C. Deetz and E. Sun Viral rebound in ARV-naïve subjects treated with ABT-378/r in a blinded Phase III study through 24 weeks has not been associated with the development of resistance. These observations, corroborated by Phase II studies in both adults and children, suggest the presence of a high genetic barrier to resistance to ABT-378/r. |
| P326 | ANTI-HIV RESPONSES AND DEVELOPMENT OF RT MUTATIONS IN ANTIRETROVIRAL-EXPERIENCED PATIENTS ADDING TENOFOVIR DF THERAPY: 48 WEEK GENOTYPIC ANALYSES OF STUDY 902 Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P326 AIDS 2000, Oct 22-26;14(Suppl. 4);S111 M.D. Miller1, N. Margot1, R. Schooley2, R. Mills1 and I. McGowan1 In conclusion, 300 mg tenofovir DF therapy shows significant and durable HIV RNA reductions among antiretroviral experienced patients with thymidine analog mutations, M184V, or both types of HIV RT mutations. |
| P327 | ESTABLISHMENT OF BIOLOGICALLY RELEVANT CUT-OFFS FOR HIV DRUG RESISTANCE TESTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P327 AIDS 2000, Oct 22-26;14(Suppl. 4);S111 Brendan A. Larder and P. Richard Harrigan These varied between 3–4.5 fold for the nucleosides, 6–10 fold for the NNRTIs and 2.5–4 fold for the PIs. For cross validation, we calculated the mean fold resistance values for a large group of genotypically ‘wild type’ samples (between 2100–7500 per drug). These values coincided almost exactly with the mean values derived from the untreated patient samples. Thus, the newly defined cut-offs are an accurate reflection of natural variation in the population and may prove to be more predictive of clinical response than existing cut-offs. Although the relationship of the new cut-offs to clinical response is still under investigation, it is already apparent that modest increases in resistance to NNRTIs (around 2.5–5 fold) do not predict treatment failure. |
| P328 | HIV GENOTYPING RESISTANCE RELATED TO ADMINISTERED ANTIRETROVIRAL TREATMENT IN THE SETTING OF CONGENITAL HIV DISEASE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P328 AIDS 2000, Oct 22-26;14(Suppl. 4);S111 R. Manfredi1, M.C. Re2, M. Vignoli2, F. Vitone2, L. Calza1 and F. Chiodo1 Resistance is the most important factor acting against long-term efficacy of HAART, but a correct performance and interpretation of both genotypic and phenotypic assays, may significantly add to an effective antiretroviral therapy. Very limited data are available about antiretroviral resistance and its clinical validation in HIV-infected children [1-3]. Our experience evaluated genomic mutations regarding all available drug classes, and confirmed the trend found in adult patients, by pointing out a clear relationship between frequency and pattern of mutations, and time of use of antiretroviral agents (classes and single compounds). AZT and 3TC were borne by the greatest resistance rate, while a more elevated sensitivity was maintained to ddI, ddC, and especially d4T. Elevated resistance was found to IDV and RTV (as the most frequently used protease inhibitor), with a worrying cross-resistance detected for NFV. The occurrence of K103N mutation in patients who never received NNRTI could limit the promising role of these novel molecules. Considering the distinguishing features of congenital HIV infection, and the growing availability of commercial resistance assays, their prognostic efficacy should be confirmed through long-term controlled studies including children with different prior antiretroviral experiences. |
| P329 | PHENOTYPIC AND GENOTYPIC RESISTANCE TESTING IN THE BERLIN COHORT OF HEAVILY PRETREATED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P329 AIDS 2000, Oct 22-26;14(Suppl. 4);S112 E. Lauenroth-Mai1, F. Schlote1, B. Schmidt2 and H. Walter1 Genotypic resistance to NNRTIs and PIs was also tested. Phenotypic resistance to ZDV/3TC and NNRTI was well correlated with genotypic resistance in our heavily pretreated patients, whereas genotypic or phenotypic resistance for DDI or D4T was rare. Mutations associated with PI resistance need further information for interpretation (e.g. number of mutations, specific mutations, treatment history). |
| P330 | EFFECT OF DIDANOSINE, ZALCITABINE AND ABACAVIR ON LAMIVUDINE RESISTANT VIRUS WITH THE M184V MUTATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P330 AIDS 2000, Oct 22-26;14(Suppl. 4);S112 C. Verhofstede, F. Van Wanzeele, B. Van Der Gucht, N. De Cabooter, E. Demecheleer and J. Plum The results of this retrospective study confirm the presence of the M184V mutation in the majority of patients after partially suppressive antiretroviral therapy containing 3TC, and the rapid disappearance of this mutation after 3TC interruption. The M184V mutation is not systematically conserved under ddI, ddC or ABC pressure. It is clear that ddI pressure is not strong enough to maintain the 184V mutation. Due to the low number of patients treated with ABC or a combination of ABC+ddI/ddC it is too early to draw firm conclusions about the value of ABC alone or in combination to sustain replication of the 184V variant. |
| P331 | HIV-1 REVERSE TRANSCRIPTASE M184V AND R211K COMBINED MUTATIONS CONCONFER PHENOTYPIC RESISTANCE TO STAVUDINE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P331 AIDS 2000, Oct 22-26;14(Suppl. 4);S112 E. Nicastri, L. Sarmati, S.G. Parisi, G. D’Ettorre, P. Narciso, V. Vullo and M. Andreoni Since R211K mutation can be considered as polymorphism, the emergence of M184V mutation in response to lamivudine could act as trigger for driving the acquisition of this multidrug resistance genotype. |
| P332 | TIME TO DETECTION AND LOSS OF M184 GENOTYPIC MUTATION AMONG HIV PATIENTS TREATED WITH 3TC AND FAILING AN HAART REGIMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P332 AIDS 2000, Oct 22-26;14(Suppl. 4);S112 F. Forbici, M. Zaccarelli, A. Bertoli, A. Barracchini, R. D’ Arrigo, M.P. Trotta, M.C. Bellocchi, O. Armignacco, G. D’ Offizi, V. Tozzi, G. Ippolito, C.F. Perno and A. Antinori The M184V mutation quickly appears among patients failing an HAART regimen including 3TC, reaching a 100% of detection among patients in therapy for > 30 months. Similarly, the M184V mutation is progressively lost after 3TC interruption, with complete reversion to wild type after 2 years. Interpretation of the data should be done with caution (in view of the potential presence of archived sequences carrying residually mutated virus), yet they may suggest the possibility of a successful recycling of some drugs whose antiviral activity is affected by M184V mutation. |
| P333A | INTERPRETATION OF PHENOTYPIC RESISTANCE TO ABT-378/RITONAVIR (ABT=378/R) IN PROTEASE INHIBITOR EXPERIENCED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P333A AIDS 2000, Oct 22-26;14(Suppl. 4);S113 D.J. Kempf, J. Isaacson, M. King, R. Rode, S. Brun, Y. Xu, K. Real, A. Hsu, G.R. Granneman, B. Bernstein and E. Sun These results suggest that ABT-378/r, as used in these studies, exerts significant antiviral activity in vivo even in patients with up to 40-fold reduced susceptibility at baseline. This is likely a consequence of a high inhibitory quotient. These results provide guidance for the use of ABT-378/r in treatment-experienced patients and for the interpretation of phenotypic resistance testing with respect to ABT-378/r regimens. |
| P333B | INTERPRETATION OF GENOTYPIC RESISTANCE TO ABT-378/RITONAVIR (ABT-378/R) IN PROTEASE INHIBITOR EXPERIENCED PATIENTS USING THE ABT-378 MUTATION SCORE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P333B AIDS 2000, Oct 22-26;14(Suppl. 4);S113 D.J. Kempf, J. Isaacson, M. King, R. Rode, S. Brun, Y. Xu, K. Real, A. Hsu, G.R. Granneman, B. Bernstein and E. Sun The number of protease mutations, rather than the presence of any single key mutation, is the best genotypic predictor of virologic response. These results may be useful to guide the interpretation of genotypic resistance testing with ABT-378/r. |
| P333C | EXAMINATION OF THE GENETIC BARRIER TO IN VIVO RESISTANCE TO ABT-378/RITONAVIR (ABT-378/R) IN PROTEASE INHIBITOR EXPERIENCED PATIENTS USING THE ABT-378 MUTATION SCORE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P333C AIDS 2000, Oct 22-26;14(Suppl. 4);S113 S. Brun, D.J. Kempf, B. Bernstein, A. Hsu, A. Molla, H. Mo, C. Deetz, K. Real, C. Renz, Y. Xu, T. Marsh, W. Freimuth 1, G.R. Granneman and E. Sun These results suggest that the genetic barrier to resistance to ABT-378/r is high, and that a genetic platform of 4–5 mutations may be required for facile evolution to occur under selective pressure by ABT-378/r. Isolates that developed resistance to ABT-378/r retained susceptibility or displayed modestly reduced susceptibility to amprenavir. In addition, all post-rebound isolates that were tested against tipranavir were fully sensitive, suggesting that amprenavir and tipranavir, which have resistance patterns dissimilar to ABT-378, may be useful with ritonavir pharmacokinetic enhancement for salvage therapy when ABT-378 resistance is present. |
| P334 | BASELINE POLYMORPHISMS FOUND IN PATIENTS INFECTED WITH NON-CLADE B HIV-1 DO NOT AFFECT OUTCOME TO HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P334 AIDS 2000, Oct 22-26;14(Suppl. 4);S113 A.J. Frater, S. Galpin, A. Beardall, J.R. Clarke, K. Ariyoshi, J.N. Weber, M.O. McClure These are the first data to demonstrate that baseline polymorphisms in pol do not impact on the outcome of therapy. We conclude that patients infected with non-B HIV-1 subtypes should respond to HAART as well as those infected with clade B HIV-1. The implications of these findings are significant; there is no virological rationale for failure to prescribe HAART to patients in Africa. |
| P335 | PERFORMANCE OF PE APPLIED BIOSYSTEMS HIV GENOTYPING SYSTEM FOR THE DETECTION OF GENOTYPIC DRUG RESISTANCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P335 AIDS 2000, Oct 22-26;14(Suppl. 4);S114 J.M. Bennett1, S. Kaye1, I.G. Williams2, J. Cartledge2 and R.S. Tedder1 Of 551 samples processed using the version 1 kit 78 samples (14%) failed to generate a PCR product. Of these, 31 samples were from patients believed to be infected with non-European virus strains. Failure to amplify 47 samples, believed to contain clade-B virus strains, suggested many amplification failures may have had a non-specific and not sequence-specific cause. From the 473 samples which gave a PCR product, only five failed to give a sequencing result of sufficient quality to report. Of these three contained non-European virus strains. Using Qiagen spin column extracted RNA in the version 1 kit, eight from 14 samples of European origin that had previously failed to generate a PCR product, amplified. However using the same modification nine samples of non -European origin still failed to amplify. Using the version 2 kit six of seven samples of European origin now amplified and four samples of African origin also amplified. Overall, the version 1 genotyping kit used in our laboratory gave good quality sequencing with the majority of samples analysed but was subject to assay failure with a proportion of samples due to non-specific inhibition of the PCR amplification step. The version 2 kit appears to be less prone to non-specific inhibition and appears to be more successful at amplifying African origin strains. |
| P336 | EVALUATION OF TWO COMMERCIAL KITS FOR THE DETECTION OF GENOTYPIC DRUG-RESISTANCE ON A PANEL OF HIV-1 SUBTYPES A-J Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P336 AIDS 2000, Oct 22-26;14(Suppl. 4);S114 E. Fontaine1, C. Riva2, M. Peeters3, J.-C. Schmit1, E. Delaporte3, K. Van Laethem2, K. Van Vaerenbergh2, E. Van Wijngaerden2, M. Van Ranst2 and A.-M. Vandamme2 All samples were successfully amplified and sequenced by the three genotyping systems, although alternative amplification and/or sequencing primers had to be used. More efforts have to be done to improve genotyping assay kits and especially to improve the performance of amplification and sequencing primers, so that all kits should allow a fast and reliable resistance testing for all HIV-1 subtypes. |
| P337 | PREVALENCE OF LOW LEVEL HIV DRUG RESISTANCE MUTANTS DETECTED USING A SENSITIVE PROBE HYBRIDIZATION ASSAY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P337 AIDS 2000, Oct 22-26;14(Suppl. 4);S114 C. Hu, C. Elkin, H. Hirmand, S. Nijjar, C.Wagner, J. Detmer, J. Weare, L.S.W. Sawyer and J.A. Kolberg The analytical performances of the assay including sensitivity, specificity, linearity and precision were measured with panels constructed with PCR amplicons of mutant and wild type sequences at various % levels. With this panel, no false positives were observed with our assay. We analyzed 254 unselected plasma samples submitted to a reference laboratory for sequencing. The protease (PR) and the reverse transcriptase (RT) regions of the purified viral RNA from plasma samples were amplified by RT-PCR. The ratios of mutants versus the wild type were quantified by their relative signal strength from the alkaline phosphatase conjugated probes measured with chemiluminescent substrate. Mutations at codons 30, 46, 48, 54, 71, 82 and 90 of the PR gene and 65, 74, 75, 184 and 215 of the RT gene were measured. Of all the specimens analyzed, 22% had mutation at low level (5 to 30%). 23% of the specimens tested had a mutation detected by our assay and was missed by sequencing. In our assay, 11% of the specimens tested had indeterminate results. Approximately half of them were from protease codon 71 mutation. We intend to refine the probe design particularly for this site to reduce the indeterminate rate. In the interest of minimizing viral replication to prevent accumulation of resistance mutations, low level and early mutant detection may prove to confer significant clinical benefit. The capability of detecting mutants at low % level may make this assay well suited for monitoring patient progress in clinical trials. |
| P338 | PERFORMANCE OF THE NEW VIROSEQ™ HIV-1 GENOTYPING SYSTEM (VERSION 2) WITH GROUP M SUBTYPE PANEL AND WITH SUBTYPE B CLINICAL SAMPLES AT TEST SITES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P338 AIDS 2000, Oct 22-26;14(Suppl. 4);S115 J. Dileanis1, N. Marlowe1, B. Hoo1, R.C. Brown1, M. Buimer2, D. Huang3, P. Palumbo4, R. Schuurman2, K. Van Laethem5, A.-M. Vandamme5 and T. Elbeik6 Internal and external testing of the ViroSeq HIV-1 Genotyping kit has shown that the kit will successfully genotype HIV-1 samples at 1000 copies/ml and higher. At viral loads from 500 to 1000 cpm, the success rate decreases slightly. In addition, testing of HIV-1 Group M subtype panel shows promising results for the use of the kit with non-B subtype HIV-1. The new ViroSeq kit was developed to improve the robustness and sensitivity of Applied Biosystems HIV-1 kit Additional features of the new kit are (1) a PCR primer redesigned to permit better detection of non-subtype B isolates, and (2) the inclusion of contamination control. This kit is for Research Use Only. |
| P339 | HIV GENOTYPING OF CLINICAL SPECIMENS WITH A NESTED RT-PCR MODIFICATION TO THE APPLIED BIOSYSTEMS VIROSEQ™ HIV-1 GENOTYPING SYSTEM Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P339 AIDS 2000, Oct 22-26;14(Suppl. 4);S115 B. Hoo1, N. Marlowe1, Tarek Elbeik2, J. Dileanis1 A nested PCR reaction can be performed using the template from the ViroSeq™ HIV-1 Genotyping System RT-PCR reaction. This nested PCR reaction protocol provides the opportunity to genotype clinical samples with low viral loads. However in one specimen at 117 copies/ml, genotypic differences were observed between the nested PCR products and suggest that caution is needed in interpretation of genotype results when the specimen viral load is low. |
| P340 | HIV-1 DRUG RESISTANCE/GENOTYPING BY A MICROARRAY BASED ASSAY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P340 AIDS 2000, Oct 22-26;14(Suppl. 4);S115 R.M. Shahinian1, R.C. Nersesian1, D.E. Birch1, V. Bodepudi1, D.M. Fong1, D.H. Gelfand1, G.R. Hillman1, N.J. Schonbrunner1, C.L. Sigua1, T. Ryder2, T.Webster2, K. Wu2 and T.W. Myers1 The entire process allows for a rapid format that requires minimal ‘hands-on-time’ and is easily automated. The high-throughput RT/PCR assay, coupled with Affymetrix GeneChip® technology, forms the basis of an HIV-1 genotyping assay for the detection of mutations associated with antiretroviral drug resistance in the diagnostic laboratory. |
| P341 | REPRODUCIBILITY OF DRUG RESISTANCE GENOTYPES IN PATIENT SAMPLES WITH LOW VIRAL LOAD USING THE APPLIED BIOSYSTEMS VIROSEQ™ HIV-1 GENOTYPING SYSTEM Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P341 AIDS 2000, Oct 22-26;14(Suppl. 4);S116 T. Elbeik1, J. Dileanis2, B. Hoo2, O. Petrauskene2 and N. Marlowe2 These experiments suggest that caution is needed when genotyping samples with low viral load values. Sequence determinations from multiple RNA preparations from the same plasma sample or from different RT-PCR products from the same RNA sample can show slight differences in genotypes with a general trend of decreasing concordance with decreasing viral load whereas genotypes from the same PCR product do not show these differences. This observation is not unexpected based on the hypothesis that as viral load decreases, the number of RNA copies added to the RT reaction is decreased and hence there may be misrepresentation of the RNA population in the resulting cDNA population. |
| P342 | PROOFREADING BY CYTOPLASMIC P53 ENHANCES THE FIDELITY OF HIV-1 RT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P342 AIDS 2000, Oct 22-26;14(Suppl. 4);S116 M. Bakhanashvili1, V. Kovalsky1, Y. Sidi2 and G. Lilling2 The misincorporation reactions carried out in the presence of p53-containing cytoplasmic fraction, demonstrate the increase in misincorporation fidelity; p53 reduced the number of mismatched nucleotides incorporated into DNA. Second, a primer extension analysis was performed with DNA substrates containing 31 terminal A : A, A : C or A : G mispair in the presence of dATP, i.e. the next correct nucleotide required for primer extension. The results show a decrease in mispair extension efficiency by HIV-1 RT in the presence of cytoplasmic p53. Instead, substantial hydrolysis of the 31 terminal mispair was observed. Immunoprecipitation of the cytoplasmic fraction by anti-p53 mAb, i.e. p53 depleted fraction, abolished the effect of p53 on the fidelity of DNA synthesis. Thus, the data suggest a possibility, that cytoplasmic p53 might act as an external proofreader for errors during proviral DNA synthesis in the cytoplasm by HIV-1 RT. |
| P343 | GENOTYPIC AND PHENOTYPIC PATTERNS IN HIV-1 INFECTED PATIENTS TREATED WITH FIRST LINE DIDANOSINE/STAVUDINE ± NEVIRAPINE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P343 AIDS 2000, Oct 22-26;14(Suppl. 4);S116 F. Raffi1, V. Calvez2, V. Reliquet1, D. Sereni3, M. Bentata4, J.M. Molina3, Z. Antoun6 and M. Ait-Khaled7 Virological rebound during d4T/ddI therapy was associated with TAMs in 9/20 patients (45%), with four patients having three or more TAMs, and more rarely with 65R and 74V. Overall, this genotypic profile selected by d4T/ddI was associated with some cross-resistance to other NRTIs. |
| P344 | CLINICAL UTILITY OF HIV-1 GENOTYPIC DRUG RESISTANCE TESTING IN A HETEROGENEOUS, NON-TRIAL POPULATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P344 AIDS 2000, Oct 22-26;14(Suppl. 4);S116 S. Coughlan1, S. Clarke2, A. Conroy1, F. Mulcahy2, W.W. Hall1 and C. Bergin2 With more than 15 antiretroviral drugs available for clinical use, all of which select for drug resistant strains, the initial evidence from the study confirms the importance of genetic analysis in routine HAART regimen design for a heterogeneous group of patients failing an initial regimen. |
| P345 | FACTORS PREDICTIVE OF MULTINUCLEOSIDE ANALOGUE-RESISTANCE MUTATIONS IN AN UNSELECTED COHORT OF HAART-FAILED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P345 AIDS 2000, Oct 22-26;14(Suppl. 4);S117 A. Antinori, R. D’ Arrigo, G. Liuzzi, M.C. Bellocchi, M.P. Trotta, A. Bertoli, A. Barracchini, F. Forbici, F. Zaccarelli, P. Narciso, P. De Longis, E. Girardi, G. Ippolito and C.F. Perno By 30 June 2000, 150 patients were enrolled [F/M 42/108; mean age 39 years; 30 (20%) MSM; 36 (24%) IVDUs; 56 (37%) heterosexual; previous AIDS 65 (43%)]. At the time of genotyping mean CD4 count was 292/mmc (range 4–1100), and HIV–RNA 4.87 (SD 0.68) log10/ml. Mean time of antiretroviral exposure was 50.6 (26.3) months, with 28.5 (22.7) of mono/ double nucleoside, and 29.1 (12.6) months of HAART. Q151M was detected in 6/150 (4%) patients. All patients with Q151M and 103/144 (71%) patients with Q151-WT had a previous ddI exp (OR n.e; P = NS); 4/6 versus 43/144 were receiving ddI at time of genotyping (OR 4.69; 95% CI OR 0.82–26.6; P = 0.07). A reduced probability of Q151M was related to 3TC exp (OR 0.07; 95% CI 0.01–0.49, P < 0.05). Q151M was associated with longer time of exposure to ddI [34.3 (SD 12.5) months for Q151M versus 9.2 (8.7) months for Q151-WT; P < 0.001], and to a shorter time to 3TC [7.7 (8.8) versus 23.5 (11.3) months; P < 0.00l]. No correlation with ZDV, ddC, d4T (neither if associated with ddI), or NNRTIs use was found. Time from last virologic failure (HIV–RNA rebound > 5000 c/ml or never undetectable) to genotyping was significantly associated to Q151M only when ddI was included in the last regimen [11.0 (9.0) months versus 2.3 (4.8); P < 0.001). Patients treated with ddI with a delayed change of therapy of > 6 months from last virological failure had a higher probability of Q151M (OR 16.0, 95% CI 2.7–94.4, P < 0.01). At logistic regression months of ddI treatment (OR 1.27; 95% CI 1.06–1.51; P < 0.01) and months of ddI exposure during last failure (OR 1.17; 95% CI 1.0–1.38; P < 0.05) were the only factors associated with Q151M genotype. No association between Q151M and other RT mutations, except for multinucleoside resistance group (V75T/I, F77L, and F116Y; P < 0.01) was found. |
| P346 | PREVALENCE OF MULTICLASS RESISTANCE AMONG ANTIRETROVIRAL EXPERIENCED HIV-1 INFECTED PATIENTS FAILING THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P346 AIDS 2000, Oct 22-26;14(Suppl. 4);S117 D. Paraskevis1, E. Magiorkinis1, M. Lazanas2, P. Gargalianos3, M. Hini1,3, V. Paparizos4, G. Panos5, G. Chryssos6, H. Sabatakou3, A. Antoniadou7, A. Karafoulidou9, M. Pappa1, G. Touloumi1 and A. Hatzakis1 The frequency of MCR was 4%, 12%, 25% and 22% at; each 4-month period, respectively (P for trend = 0.02). The increasing prevalence of MCRs is due to the extensive use of antiretroviral drugs and has direct; implications in the control of HIV-1 disease, since the proportion of patients with limited treatment options seems to be increasing rapidly. |
| P347 | SEXUAL TRANSMISSION OF MULTI-DRUG RESISTANT HIV-1: EVIDENCE FOR COMPLEX VIRAL EVOLUTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P347 AIDS 2000, Oct 22-26;14(Suppl. 4);S117 S. Taylor1, P. Cane1, J. Clarke2, R. Hextall3, J. Workman1, D. Radcliffe1, J. Ball4 and D. Pillay1 Although epidemiological and pol phylogenetic data suggest linkage of these two cases, this is not supported by sequence data from C2V3 and p17. These data illustrate the complex evolutionary manifestations of the sexual transmission of HIV. These may be related to viral compartmentalisation in the genital tract, stochastic/selective transmission events, and/or multiple infection events. In the latter case, this may include more indirect epidemiological linkage between cases. |
| P348 | PHENOTYPIC MULTI-NUCLEOSIDE RESISTANCE LINKED TO THE Q151M MUTATION IS ENHANCED UNDER THE SELECTIVE PRESSURE OF ACYCLIC NUCLEOTIDE ANALOGS BUT REDUCED BY FOSCARNET Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P348 AIDS 2000, Oct 22-26;14(Suppl. 4);S118 K. Van Laethem, M. Witvrouw, C. Pannecouque, B. Van Remoortel, R. Esnouf, J. Balzarini, J. Desmyter, E. De Clercq and A.-M. Vandamme These data show that the phenotypic multi-nucleoside resistance linked to the Q151M mutation was enhanced following resistance selection with acyclic nucleotide analogs but reduced by foscarnet. These phenotypic changes were associated with the emergence of the K65R and D113V mutation, selected under the pressure of the acyclic nucleotide analogs and foscarnet, respectively. |
| P349 | PRIMARY AND SECONDARY MUTATIONS IN THE RT AND PROTEASE GENE IN HIV-1 INFECTED PATIENTS PREDICT FAILING TO SPECIFIC ANTIRETROVIRAL COMBINATION THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P349 AIDS 2000, Oct 22-26;14(Suppl. 4);S118 K. Arasteh1, V. Simon1, T. Sternfeld1, A. Kunz1, T. Zwingers2, M. Kurowski1, M. L’ Age1 Different factors (i.e. resistance, suboptimal drug-levels) may contribute to virological ART failure. We demonstrated that genotyping helps identifying failing drugs of a current ART but the significance of the testing differs highly with regard to the agents. For a number of drugs we found a significant correlation between failure and presence of mutations. AZT and saquinavir specific primary mutations were detected even though the compounds were not part of the regimen, suggesting that these mutations exist for longer periods without a specific selective pressure. |
| P350 | HIV-1 GENETIC SUBTYPES AND ANTIRETROVIRAL THERAPY RESISTANCE TESTING Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P350 AIDS 2000, Oct 22-26;14(Suppl. 4);S118 S. Galpin, S. Beddows, A. Johargy, A. Ashraf, A.J. Prater, N. White, J. Clarke, M. McClure and J.N. Weber These data emphasise the importance of ensuring primer sequences used in routine tests are regularly checked against new and divergent subtypes occurring in the local patient population. This subtype panel is a valuable resource, itself needing to be updated regularly to include new divergent strains. |
| P351 | COMPARTMENTALISATION OF HIV-1 RESISTANCE MUTATIONS BETWEEN THE LUNG AND BLOOD Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P351 AIDS 2000, Oct 22-26;14(Suppl. 4);S118 N. White, D. Israel-Biet, R. Coker, D. Mitchell, J.N. Weber, J.R. Clarke Differences exist between the HIV quasispecies both between the lung and blood, and within each compartment. Phylogenetic analysis shows no evidence of distinct evolution within a compartment which may result in different mutation patterns. Therefore, the differences in mutations between the lung and blood may be due to differences in drug penetration, intracellular drug levels or phosphorylation of NRTIs. These data may help to understand the basis of drug failure on HAART. |
| P352 | EVALUATION OF ANTIRETROVIRAL THERAPY WITH D4T/DDI/EFV IN HIV-INFECTED PATIENTS INCLUDING GENOTYPIC RESISTANCE TESTING IN BLOOD, CSF AND SEMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P352 AIDS 2000, Oct 22-26;14(Suppl. 4);S119 M. Hartmann1, A. Klein1, U. Juschka1, J. Haas2, K. Stingele2 and B.Wildemann2 The twice daily dose regime with D4T, DDI and EFV was potent and effective in reducing viral load mainly in naïve patients and preventing AIDSdefining events. Intervention with triple HAART reduces HIV shedding in semen and CSF to undetectable levels. The updated data will be presented. |
| P353 | DRUG RESISTANCE IN PATIENTS EXPERIENCING EARLY VIROLOGICAL FAILURE UNDER A TRIPLE COMBINATION INCLUDING INDINAVIR Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P353 AIDS 2000, Oct 22-26;14(Suppl. 4);S119 O. Gallego, C. de Mendoza, M.J. Pérez Elías, A. Corral, A. Moreno, I. García-Arata, J. Pedreira, D. Dalmau, J. Gonzàlez, J. Guardiola and V. Soriano The mean level of plasma viremia at rebound was 7824 HIV-RNA copies/ml in group 1. Genetic sequence analyses yielded results in a total of 48 (68.5%) of them. Half of samples (24/48, 50%) carried primary mutations associated with resistance to nucleosides, meanwhile less than one third (13/48, 27%) showed primary PI mutations (P < 0.05). In 22 (45.8%) subjects there was no evidence of drug-resistant viruses. The most frequent drugresistant genotypes at the RT gene were at codons 184 (n = 17), 215 (n = 13), 41 (n = 7), 74 (n = 1), 75 (n = 1), and 69 (n = 2), whereas for the protease were at codons 46 (n = 9), 82 (n = 8), 90 (n = 7), 48 (n = 1), and 30 (n = 1). No resistance genotypes were recognised in patients belonging to group 2. Overall, drug-resistant genotypes were recognised in 37.14% (26/70) of compliant subjects experiencing a first virological failure under a triple combination including IDV, being resistance to nucleosides more frequent than to IDV. Therefore, these patients might be candidates for either a selective substitution of nucleosides or treatment intensification. The lack of resistant virus genotypes in at least 42% of compliant patients experiencing early virological failure might reflect primarily or diminished adherence to treatment and/or a progressive loss of antiviral potency by drugs in use over time. |
| P354 | DRUG RESISTANCE IN A TRIAL OF NUCLEOSIDE ANALOGUE AND PROTEASE INHIBITOR THERAPY IN CHILDREN (PENTA 5) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P354 AIDS 2000, Oct 22-26;14(Suppl. 4);S119 Steve Kaye At baseline, no high-level resistance was observed. Six of 104 samples showed intermediate phenotypic resistance to an NRTI [ZDV (1), 3TC (1), ddI (1), ddC (2), d4T (1)] and 19 and 14 samples, intermediate resistance to delavirdine and nevirapine respectively. Baseline resistance was not related to response to therapy. No resistance to any drug was observed in nine (36%) children with rebound and four (29%) non-responders over a median period of 23 (0–65) weeks with VL > 2000 copies/ml. High-level 3TC resistance was observed in 88% of children assigned to receive the drug and all had the M184V mutation. Only two of 26 children receiving ZDV had resistance (one intermediate; one high-level) and six of 21 children on ABC developed intermediate resistance. Among those on 3TC+ABC, all had the M184V mutation but only half had intermediate phenotypic ABC resistance. Eight of 27 children on NFV developed resistance (four intermediate; four high-level), but cross-resistance to other PIs was not observed. Failure to develop resistance to both ABC and ZDV or 3TC may explain the better response seen in the ABC containing arms. However, therapy failure or non-response was observed in a significant, number of children with no evidence of resistance to ABC, ZDV or NFV. |
| P355 | GENOTYPIC ANTIRETROVIRAL-RESISTANCE-ANALYSIS IN HIV-1 POSITIVE PATIENTS WITH TREATMENT FAILURE FROM ARGENTINA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P355 AIDS 2000, Oct 22-26;14(Suppl. 4);S120 J. Benetucci1, A. Petroni1, E. Illescas2, G. Deluchi1, G. Serebrinsky2, and J. Garberi2 A genotypic analysis after stopping therapy could probably give ambiguous information which lead to incorrect clinical decisions. The new two-aminoacid (aa) insertion described here, in addition to the 20 insertionvariants described to date, contributes to support the existence of a global mechanism conferring MNR and involving variable aa-insertions in the 68–70 codon region of RT. Phenotypic assays are needed to state the role of the association between ZDV-RM and substitutions K43E/N/Q, which may be involved in ZDV+3TC dual resistance as described for E44D/A. |
| P356 | FREQUENCY OF MUTATIONS IN THE REVERSE TRANSCRIPTASE (RT) OF NON-B ISOLATES IN HIV-1-INFECTED PREGNANT WOMEN IN KIGALI, RWANDA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P356 AIDS 2000, Oct 22-26;14(Suppl. 4);S120 V. Arendt, C. Lambert, E. Karita, D. VanHove, C. Holtzer, J.M. Plesseria, J. Servais, R. Hemmer, F. Schneider, T. Staub and J.C. Schmit No K103N was found and only one K103R mutation was found in non-B isolates from treatment-naïve pregnant women from Rwanda. Some other baseline mutations in positions associated typically with resistance to NRTI and NNRTI were observed. However most of the amino acid substitutions found are not reported to be associated with any significant resistance. Subtype A remains the main subtype in Rwanda. Isoleucine (I) is the predominant residue at position 179 in subtype A isolates. |
| P357 | GENOTYPIC PATTERNS OF PROTEASE GENE MUTATIONS AND ITS CORRELATION WITH PLASMA VIREMIA IN HIV-1 INFECTED SUBJECTS FAILING A PROTEASE INHIBITOR CONTAINING REGIMEN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P357 AIDS 2000, Oct 22-26;14(Suppl. 4);S120 D. Bertelli, S. Casari, C. Barni, E. Quiros Roldan, C. Gagliotti and G.P. Cadeo In patients failing a PI containing regimen, a low level of HIV replication is correlated to the absence of primary mutations of the protease gene. In this case report, the increasing number of secondary mutations per patient, does not seem to be correlated with the highest level of HIV-viremia. |
| P358 | PERFORMANCE OF A HIV-1 GENOTYPING ASSAY WITH NON-B SUBTYPES: THE EAST LONDON EXPERIENCE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P358 AIDS 2000, Oct 22-26;14(Suppl. 4);S120 I. Ushiro-Lumb1, J. Norman1, C. Skinner2. M. Murphy2, J. Breuer1 and C. Aitken1 Eighty-seven (93.5%) samples were successfully genotyped in our laboratory. Amongst the 64.2% white patients (Europe, North and South America), all except one had subtype B. One strain from a white/English patient clustered as a A/C. Amongst the 27.2% of black/Africans, subtypes A, B, C and D were detected (36%, 4%, 20% and 32%, respectively), with two samples showing chimeric sequences in the regions analysed. Black/Caribbeans accounted for 4% and harboured subtype B only. Three individuals were black/European and also had subtype B virus. Six sequence failures occurred, but all were successfully genotyped by the manufacturer, using the same system. The subtypes for those samples were B (four), A (one) and D (one). The TruGene™ assay is a robust HIV-1 subtyping system, which is easily incorporated into a diagnostic laboratory. There is no suggestion that failure to obtain sequence data was due to inability of the system to amplify non-B targets. With up to 27% of our samples belonging to non-B subtypes, we have demonstrated that the VGI system can reliably detect mutations in non-B subtypes. |
| P359 | DOES HIV-1 SUBTYPE INFLUENCE GENOTYPIC CHANGES ASSOCIATED WITH ANTI-RETROVIRAL FAILURE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P359 AIDS 2000, Oct 22-26;14(Suppl. 4);S121 I. Ushiro-Lumb1, J. Norman1, C. Skinner1, M. Murphy2, J. Breuer1 and C. Aitken1 There was no difference in the mean number of drugs received in the two groups (B/non-B).The frequency of critical resistance mutations in the RT and PR genes were not significantly different, except for M36L Our preliminary data suggests that emergence of resistance-related amino acid substitutions is not influenced by different HIV-1 subtypes; it follows that the therapeutic choice should not be influenced by the strain subtype. Nevertheless, the numbers are low and we will continue to monitor the mutation frequencies. Such data will have important impact on the clinical management of any group of patients such as ours amongst which up to 27% of isolates are non-B subtypes. |
| P360 | PREVALENCE AND PATTERNS OF RESISTANCE TO FAILING COMBINATION THERAPY WITH NEVIRAPINE IN PATIENTS INFECTED WITH NON-B HIV-1 SUBTYPES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P360 AIDS 2000, Oct 22-26;14(Suppl. 4);S121 A.M. Geretti1,2, M. Smith2, M. Donati2, M. Zuckerman2 and P. Easterbrook1 The patterns of antiretroviral resistance remain largely undefined in patients infected with HIV-1 subtypes other than B. Our preliminary data indicate that the mutation K103N may be uncommon in this population, whereas atypical mutations appear to be highly prevalent. Results of phenotypic assays will be presented. |
| P361 | GENOTYPIC PATTERNS AFTER VIROLOGIC FAILURE FOLLOWING 24 WEEKS OF TRIPLE NUCLEOSIDE THERAPY IN UNDER-REPRESENTED AND INCARCERATED POPULATIONS (NZTA4006, 4007) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P361 AIDS 2000, Oct 22-26;14(Suppl. 4);S121 D.R. McClernon1, J. Gathe2, M. Thompson3, C. Farthing4, M. Fischl5, L. Kirkland8, S. Hessenthaler1, M. Shaefer1, M. St Clair1 and J. Hernandez1 Overall, 63% of failures occurred in the absence of any RT mutations (18/ 26 in NZTA4006 and 2/6 in NZTA4007). Only 28% of failures acquired M184V during the study and none acquired new thymidine analog mutations during the study. Subjects exhibiting VF should remain susceptible to most nucleoside RT inhibitors, all nonnucleoside RT inhibitors, and all protease inhibitors. |
| P362 | LOW PREVALENCE OF ANTIRETROVIRAL DRUG RESISTANCE MUTATIONS IN DRUG NAÏVE PATIENTS WITH ESTABLISHED HIV INFECTION IN THE UK Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P362 AIDS 2000, Oct 22-26;14(Suppl. 4);S121 Andy Burke, Nicola Thorne and Clive Loveday on behalf of the RCCG, UK The first antiretroviral therapy received by patients with HIV/AIDS appears to generally provide the best clinical response. Current resistance guidelines propose that testing of drug naïve patients with established infection should be considered but not routinely performed. This study suggests that resistance testing may not currently be required in the UK for this group of patients. We are continuing to increase our dataset and will be monitoring for any increases in the prevalence of resistance in this patient group. |
| P363 | FREQUENCY OF MUTATIONS ASSOCIATED WITH ANTIRETROVIRAL DRUG RESISTANCE IN PATIENTS UNDERGOING PRIMARY HIV-1 INFECTION (PHI) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P363 AIDS 2000, Oct 22-26;14(Suppl. 4);S122 Louise C. Dann1, Clive Loveday1, Susan Allison1, Sabine Kinloch2 and Margaret Johnson3 In this retrospective analysis of genotypic drug resistance in seroconverters, six patients (18%) had one or more primary mutations and 26 (63%) had primary and/or secondary mutations (excluding protease L63P). Resistance testing to define therapeutic options would have had a role in these patients. |
| P364 | INCIDENCE OF TRANSMITTED ANTI-RETROVIRAL DRUG RESISTANT HIV MAY BE RISING IN THE UK Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P364 AIDS 2000, Oct 22-26;14(Suppl. 4);S122 G.L. Dean2, P.A. Cane1, D. Pillay1, D.R. Churchill2, M.J. Fisher2 and K. Porter3 on behalf of the UK Register of HIV Seroconverters and the PHLS Antiviral Susceptibility Reference Unit There is clear evidence that drug resistant virus is being transmitted and our data suggest that the incidence of transmission in the UK has risen since HAART became widely used. |
| P365 | PREVALENCE OF DRUG RESISTANT GENOTYPES IN PATIENTS WITH VIROLOGICAL FAILURE IN THE UK Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P365 AIDS 2000, Oct 22-26;14(Suppl. 4);S122 A.V. Vrettou, A. Burke and C. Loveday A high prevalence of mutations associated with drug resistance to all drug classes exists in this patient cohort failing antiretroviral therapy across the UK. It is therefore necessary to continue resistance surveillance to broadly guide future therapies, and specifically assist in individual patient care. |
| P366 | MULTIDRUG RESISTANCE (MDR) AND CLINICAL OUTCOME Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P366 AIDS 2000, Oct 22-26;14(Suppl. 4);S122 L. Bocket, F. Ajana, E. Senneville, Y. Yazdanpanah, Y. Gerard, Y. Mouton and P. Wattre This study points out that MDR are rarely detected in experienced patients (1.5%). In addition they seem non associated with HIV progression, even for the patient who maintains the same treatment. All the patients have been exposed to ZDV alone and/or combined with DDI or DDC. The change of therapeutic regimen improved the clinical and virological outcome for four patients. Sustained MDR persistence would be investigated through to the follow-up. |
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10.3 HEPATITIS Abstracts P367 thru P394, Pages S123 TO S126 |
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| P367 | INTERFERON-α AND RIBAVIRIN COMBINATION THERAPY FOR HEPATITIS C IN HIV-COINFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P367 AIDS 2000, Oct 22-26;14(Suppl. 4);S123 J.K. Rockstroh, G. Klausen1, J. Golz1, S. Dupke2, L. Stein3, G. Notheis4, A. Stoehr5, G.R. Pascucci6, J.C. Wasmuth and S. Mauss7 After 12 weeks of treatment with interferon and ribavirin 50% of treated patients have become HCV-RNA negative. Drop-out rate due to adverse events is high with 25% during the first 8 weeks. HIV-RNA was not adversely affected, indicating that the concomitant use of ribavirin and antiretroviral treatment may be safe. |
| P368 | LACK OF SIGNIFICANT VIRAL LOAD ALTERATIONS OF HEPATITIS B VIRUS (HBV) AND HEPATITIS C VIRUS (HCV) DURING TREATMENT WITH INTERLEUKIN-2 AND HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P368 AIDS 2000, Oct 22-26;14(Suppl. 4);S123 U.R. Hengge, M. Roggendorf, S. Esser and M. Goos The reduction of the mean HIV-1 RNA load (HIV RNA 2.0, Bayer Diagnostics) from 18 613 ± 36 355 pre-treatment to 5448 ± 5220 after 1 year did not reach statistical significance (P = 0.248). Despite the lack of HI-virus clearance from the blood there was a significant 22% increase in CD4 cells from 389 ± 186 to 472 ± 226 (P = 0.041) and a relative increase of CD4 cells from 22.2 ± 10.1 to 25.6 ± 11.0% during the 12- month study period. In conclusion, our results suggest that IL-2 can be safely administered to coinfected HIV-patients with respect to HBV/HCV load and liver function despite an augmented Th1-like immune profile. However, the data also provide evidence that the observed increase in lymphocyte numbers does not translate into a reduction of HBV or HCV load in plasma as could be expected from an improvement of lymphocyte function. Our data are important for administering IL-2 to patients with hepatitis participating in phase III trials addressing the clinical benefit of adoptive IL-2 therapy (SILCAAT and ESPRIT). |
| P369 | TREATMENT OF HIV+ SUBJECTS CO-INFECTED WITH HEPATITIS B OR C: SAFETY AND EFFICACY COMPARISON OF ABT-378/RITONAVIR (ABT-378/R) VERSUS NELFINAVIR FROM A PHASE III BLINDED RANDOMIZED CLINICAL TRIAL Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P369 AIDS 2000, Oct 22-26;14(Suppl. 4);S124 J. Arribas1, C. Barros2, J. Gonzalez-Lahoz3, W. Cameron4, R. Rubio5, F. Altice6, B. Clotet7, M. King8, P. Cernohous8, J. Moseley8, M. Sattler8, B. Bernstein8 and E. Sun8 for the M98–863 Study Team Hepatitis B/C+ subjects had a higher incidence of Grade 3/4 elevations of AST/ALT than did other subjects. Efficacy and other safety results for Hepatitis B/C+ subjects were generally similar to hepatitis B/C negative subjects. Of the Hepatitis B/C+ subjects, there were no discontinuations due to elevated liver enzymes or clinical hepatitis. |
| P370A | THE LOAD VIRAL OF HEPATITIS C VIRUS (HCV) CORRELATES AND CD4+ AND CD4+CD28+ LYMPHOCYTES IN CO-INFECTION PATIENTS OF HIV–HCV Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P370 AIDS 2000, Oct 22-26;14(Suppl. 4);S124 J. Carmena, C. Ricart, M. Jordan, M. Maciá, M.J. Alcaraz, C. Santos, M.S. Monzón and G. Vila The load viral of HCV correlates in a way inverse with the CD4 lymphocytes, CD4+CD28+ lymphocytes and CD28 lymphocytes total and not with the load viral of HIV. |
| P370B | THE HAART IN PATIENTS WITH CHRONIC HEPATITIS BY HEPATITIS C VIRUS (HCV) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P370 AIDS 2000, Oct 22-26;14(Suppl. 4);S124 J. Carmena, C. Ricart, M. Maciá, M. Jordan, J. Alcaraz, C. Santos, M.S. Monzon and G. Vila The increase of CD4 lymphocytes caused by HAART does not alter the ALT nor the HCV viral load. |
| P371 | CO-INFECTION WITH HIV AND HEPATITIS C: A COMPARISON BETWEEN PRISONERS AND NON-PRISONERS AND RESPONSE TO HAART THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P371 AIDS 2000, Oct 22-26;14(Suppl. 4);S124 P. Ford, M. Dockrill, J. Veal, J. Datema and W.L. Wobeser The percentage of non prisoners reporting IV drug use as their risk factor doubled over the periods studied, but their HCV prevalence remained the same. This may be due to increased recognition of IV drug-use as an important risk factor. HCV did not appear to influence treatment success, but despite similar rates of HAART utilization the percentage of patients achieving an undetectable viral load was significantly lower in prisons. |
| P372 | RAPID DECLINE OF CD4 POSITIVE T-CELLS DURING HCV-TREATMENT WITH RIBAVIRIN AND IFN-α IN AN HIV-POSITIVE HAEMOPHILIAC Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P372 AIDS 2000, Oct 22-26;14(Suppl. 4);S125 S. Urschel, U. Wintergerst, A. Jansson, G. Notheis and B.H. Belohradsky To our knowledge this phenomenon was observed in a haemophiliac for the first time. We conclude that the drop of CD4-cells was either due to IFN-a, or a formerly unreported side effects of ribavirin. Sera of before and after the event have been stored to analyse the titres of gp41 antibodies cross-reacting to a HLA 2 sequence, that have been accused for the decline. This analysis is still in progress. |
| P373 | HEPATITIS C: PREVALENCE AND IMPLICATIONS FOR TREATMENT IN THE HIV COINFECTED POPULATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P373 AIDS 2000, Oct 22-26;14(Suppl. 4);S125 S. Hopkins, K. Rogers, S. Clarke, F. Lyons, F. Mulcahy and C. Bergin Our figures correlate with results from previously reported studies. This is an ongoing data collection and prospective study of the response to HCV therapy in HIV coinfected patients. Data from the complete cohort, early response to therapy and cost analysis will he presented. |
| P374 | NATURAL HISTORY OF HEPATITIS B IN HIV CO-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P374 AIDS 2000, Oct 22-26;14(Suppl. 4);S125 K. Templeton1, C.J. Skinner, A. Kirk, H. Wheeler, C. Aitken1 Significant fluctuations in HIV DNA over time were observed and many of these changes were related to 3TC usage. The clinical relevance of these viral flares remains unclear as longer follow up is required. Close monitoring of all HBV markers is essential in the management of co-infected patients specifically in the context of 3TC prescription. |
| P375 | THE EFFECT OF HAART ON RETINAL AND EXTRAOCULAR CYTOMEGALOVIRUS INFECTION IN PATIENTS WITH AIDS IN EUROPE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P375 AIDS 2000, Oct 22-26;14(Suppl. 4);S126 I. Yust, A. Mocroft, D. Turner, C. Katlama, B. Clotet, O. Kirk, J. van Lunzen, P. Reiss, M. Burke, A. Chiesi, J. Lundgren for the EuroSIDA Study Group In summary, the HAART era has had a major impact on reducing the incidence of CMVEO and CMVR and their associated mortality, as well as allowing cessation of anti-CMV maintenance therapy. |
| P376 | TREATMENT OF INTESTINAL WORMS DECREASES HIV PLASMA VIRAL LOAD Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P376 AIDS 2000, Oct 22-26;14(Suppl. 4);S126 Z. Bentwich, D. Wolday, Z.G. Mariam, S. Maayan and A. Landay Eradication of helminth infection may significantly decrease HIV plasma viral load and thereby slow progression of HIV infection. Deworming is a low-cost and feasible treatment for most developing countries where helminth infections are almost universal and HIV is rampant. Considering the small size of the present study and its potentially wide implications, it should be repeated in larger populations and different geographical locations. |
| P377 | HELMINTHIC INFECTIONS HAVE A MAJOR IMPACT ON PATHOGENESIS OF AIDS AND DEVELOPMENT OF HIV PROTECTIVE VACCINES IN THE DEVELOPING COUNTRIES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P377 AIDS 2000, Oct 22-26;14(Suppl. 4);S126 Z. Bentwich, A. Kalinkovich, G. Borkow, M. Stein, L. Qibin and Z. Weisman Helminthic infections have a profound impact on host’s immunity due to the chronic immune activation they cause. The immune activation makes the host more susceptible to HIV infection and impaired in generating cellular immunity. The impaired host immunity may undermine HIV protective vaccine efficacy. Development and trial of HIV vaccines in developing countries must take into account host background immunity and eradication of helminths before their wide application. |
| P378 | IN VITRO EFFECT OF INSECT AND MAMMALIAN CECROPINS ON CRYPTOSPORIDIUM PARVUM INFECTIVITY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P378 AIDS 2000, Oct 22-26;14(Suppl. 4);S126 A. Giacometti, O. Cirioni, M.S. Del Prete, F. Barchiesi, F. Ancarani, D. Drenaggi, M. Fortuna and G. Scalise Cecropin P1 showed more anti-cryptosporidial activity than cecropin A and B. The cationic peptides perturb membrane functions responsible for osmotic balance in susceptible organisms. Two points can be debated: first, the mammalian intestinal cecropin P1 might be more specifically adapted to act against intestinal pathogens; second, sporozoites might be more susceptible than oocysts because their cytoplasmic membrane is directly exposed while, inside oocyst, the sporozoites are surrounded by an additive single-unit membrane and by the thick, two-layered, environmentally resistant oocyst wall. |
| P379 | VIRAL LOAD (VL) AND CD4 CELLS (CD4) IN PATIENTS WITH DISSEMINATED TUBERCULOSIS (DT) AND PULMONARY TUBERCULOSIS (PT) AFTER HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P379 AIDS 2000, Oct 22-26;14(Suppl. 4);S127 J. Pedreira, J. Juega, M.A. Castro, S. Pita and S. López Calvo 1.-Tuberculosis (DT and PT) continues to be the first AIDS defining event after HAART (42% of total amount of AIDS cases in our hospital). 2.-DT occurs at an advanced stage of VIH infection associated to severe immunosuppression while PT occurs in patients that have an immunological system relatively better preserved (CD4 T-cell count and VL are significantly different in both groups). 3.-Consequently, we believe that patients with DT are likely to have a poor prognosis and little benefit of HAART. |
| P380 | EXTRAPULMONARY TUBERCULOSIS IN HIV-POSITIVE PATIENTS: A RETROSPECTIVE ANALYSIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P380 AIDS 2000, Oct 22-26;14(Suppl. 4);S127 R. Podlasin, D. Latarska, J. Gizi Dska, N. Zalewska1, P. Grabczewski, K. Koch, E. Pastuszka, I. Wierzchowska and B. Sawicka The aim of the study is retrospective analysis of extrapulmonary tuberculosis (exptbc) in HIV(+) patients hospitalised from 1993 to March 2000 in the IVth Division of Hospital for Infection Diseases in Warsaw. |
| P381 | MULTIDRUG-RESISTANT TUBERCULOSIS (MDRTB) CORRELATES WITH SHORTER SURVIVAL IN HIV-INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P381 AIDS 2000, Oct 22-26;14(Suppl. 4);S127 H. Perez, G. Ben, M. Tocci, G. De la Iglesia, E. Delsol, S. Kaufman, L. Barrera and P. Cahn In our HIV-infected population disseminated TB is the most common clinical presentation. Susceptibility showed correlation with survival. Resistance to one or more drugs is a marker of poorer prognosis in our series. Since 25% of our isolates showed resistance to one or more drug, and given the above mentioned correlation with negative outcome, susceptibility tests should be performed in clinical practice in areas with high prevalence of drug resistance. |
| P382 | EFFECTIVENESS OF TUBERCULOSIS PROPHYLAXIS ACCORDING TO THE ADHERENCE TO THE ANTIRETROVIRAL TREATMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P382 AIDS 2000, Oct 22-26;14(Suppl. 4);S127 F. Aizpuru, J.J. Portu, M. Aldamiz-echebarria, J.M. Agud, M. Ibarra, C. Ayensa, M. Gómez and M.J. Ramirez The effectiveness of TB prophylaxis in HIV(+) patients is independent of the adherence to the antiretroviral treatment. |
| P383 | INTERFERON-γ IN RESISTANT OROPHARYNGEAL CANDIDIASIS IN AN HIV POSITIVE PATIENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P383 AIDS 2000, Oct 22-26;14(Suppl. 4);S128 N. Bodasing, R.A. Seaton, G. Shankland and A. Pithie Within 3 weeks of commencing this therapy there was a dramatic improvement in symptoms and signs of oropharyngeal candidiasis. After 4 months interferon-gamma was discontinued and within 4 days there was recurrence of his symptoms. Interferon-gamma treatment was therefore re-introduced successfully. Further studies are required to investigate the use of interferongamma as an adjuvant treatment for oropharyngeal candidiasis. |
| P384 | LOW RATE OF OPPORTUNISTIC EVENTS IN SUBJECTS WITH LOW CD4 COUNTS AND INCOMPLETE VIRUS SUPPRESSION UNDER HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P384 AIDS 2000, Oct 22-26;14(Suppl. 4);S128 A. Saez, V. Serrano, P. Barreiro, V. Soriano and J. González-Lahoz In conclusion, in patients under HAART with advanced HIV disease, low CD4 counts and incomplete virus suppression, the incidence of opportunistic events is lower than what was reported in the pre-HAART era (23–34% patient-years). A reduction in viral fitness and/or a restriction in viral tropism could explain this lower pathogenicity. |
| P385 | AIDS-DEFINING EVENTS IN PATIENTS STARTING PROTEASE INHIBITORS (PI) IN VERY ADVANCED HIV DISEASE (BELOW 50 CD4/mm³): AN ANALYSIS OF 338 CLINICAL EVENTS FROM A RANDOMIZED CLINICAL TRIAL Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P385 AIDS 2000, Oct 22-26;14(Suppl. 4);S128 M. Floridia, S. Vella, C. Tomino, V. Fragola, R. Bucciardini, M.C. Galluzzo, G. Giannini, M.F. Pirillo and M. Andreotti Results, which are based on a cumulative follow-up period of about 10 000 person-months, suggests that when PI are started at a very low CD4 level, risk of clinical events is maintained in the first weeks after starting treatment and in patients who do not restore CD4 counts above 200/mm³. AIDS-defining events showed to be infrequent in patients who achieve this target. The analysis of PCP events supports the strategy of withdrawing prophylaxis above 200 CD4/mm³. |
P386 | CESSATION OF SECONDARY PROPHYLAXIS IN PATIENTS WITH CRYPTOCOCCOSIS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P386 AIDS 2000, Oct 22-26;14(Suppl. 4);S128 N. Nwokolo1, M. Fisher2, M. Nelson1 This small study suggests that it may be possible to stop secondary antifungal prophylaxis in certain patients on HAART without a relapse of cryptococcal disease. Further studies involving larger numbers are needed, however, to ascertain whether or not this is indeed the case. |
| P387 | RECOVERY FROM PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY FOLLOWING DIRECTLY OBSERVED HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) IN A SPECIALISED BRAIN IMPAIRMENT UNIT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P387 AIDS 2000, Oct 22-26;14(Suppl. 4);S129 S. Rackstraw, A. Conley and J. Meadway Patients with progressive multifocal leukoencephalopathy (PML) continue to be considered to have a poor prognosis even in the era of HAART [1]. We seek to demonstrate that even patients that have failed to improve on antiretroviral therapies in the past, may improve when they are placed in a stable environment in a specialist rehabilitation unit, and antiretroviral therapy is administered under direct observation and supervision. Case notes of patients admitted with PML were reviewed to determine progress prior to admission to the unit, and on the unit. Two case histories are detailed. They illustrate that within a specialist brain impairment unit, the environment of rehabilitation is important in enabling the successful administration of a directly observed anti retroviral therapy to patients. This has led to dramatic neurological improvement in both patients. We conclude that neurological improvement on HAART in patients with PML may be dependent on its initiation within a rehabilitation unit, in patients that have not improved in other settings. |
| P388 | A PROSPECTIVE STUDY TO EXAMINE THE EFFECT OF HIV-PROTEASE INHIBITOR THERAPY ON CLINICAL SIGNS OF ORAL CANDIDOSIS AND ORAL CANDIDA CELL DENSITY IN AN IVDU POPULATION WITH AIDS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P388 AIDS 2000, Oct 22-26;14(Suppl. 4);S129 C.E. McCreary1,2, D.C. Coleman1 and F.M. Mulcahy2 In 31 patients (59.6%) Candida albicans was the only species isolated, 13 patients (25%) yielded C. albicans and other Candida species (including, C. glabrata, C. dubliniensis and C. tropicalisi). In eight patients (15%), only non-C. albicans Candida species were isolated. The results of this study demonstrate that although HIV-protease inhibitor therapy significantly reduces the incidence of observable clinical signs (P < 0.001) of oral candidosis, patients continue to carry extremely high oral Candida loads. |
| P389 | INTRAVITREAL TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS WITH FOMIVIRSEN (VITRAVENE™) IN PATIENTS WITH AIDS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P389 AIDS 2000, Oct 22-26;14(Suppl. 4);S129 Christina Meenken, Gerardus J. van den Horn and Marc D. de Smet Fomivirsen (Vitravene™) is an effective and safe treatment for otherwise unresponsive CMV-retinitis in patients with AIDS. |
| P390 | USEFULNESS OF SPLEEN BIOPSY IN THE DIAGNOSIS OF TUBERCULOSIS IN HIV INFECTED PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P390 AIDS 2000, Oct 22-26;14(Suppl. 4);S129 E. Valadas, R. Badura, A. Gonçalves1 and M.J. Quaresma Multiple small hypoechoic lesions in the spleen of HIV infected patients are highly suggestive of tuberculosis. Spleen biopsy may be an alternative diagnostic method for HIV patients with spleen lesions. |
| P391 | THERAPY OF KALA-AZAR IN PATIENTS INFECTED BY HIV-1: A RETROSPECTIVE EVALUATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P391 AIDS 2000, Oct 22-26;14(Suppl. 4);S130 Robert A. Badura and Joana Quaresma Being aware of the limited number of files in this evaluation, statistical extrapolations should be careful. Nonetheless our observations confirms former studies, like these done in Spain. Thus, at least an alike degree of efficacy can be confirmed, and what relates to adverse effects a similar number has been observed in both therapeutic groups. Having in mind the more serious side effects of liposomic amphotericine B, we found to be able to conclude that the first choice of therapy in cases of infections by Leishmania infantum in Portugal, should be pentavalent antimonial derivatives. |
| P392 | CEREBRAL TOXOPLASMOSIS OVER THE LAST 10 YEARS IN A 2394 PATIENT COHORT IN BRUSSELS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P392 AIDS 2000, Oct 22-26;14(Suppl. 4);S130 N. Clumeck, S. De Wit, B. Sommeijns and A. Barath CT has been a major cause of morbidity and mortality in our cohort of patients. Although introduction of HAART led to a significant decline of its incidence, it is more frequently diagnosed as first AIDS manifestation and occurs both in treated and untreated patients. |
| P393 | MANAGEMENT OF TOXOPLASMOSIS IN LIMITED RESOURCES Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P393 AIDS 2000, Oct 22-26;14(Suppl. 4);S130 S.D. Jujar, D.G. Saple and J.-K. Maniar $200 is enough for managing patients of toxoplamosis in General Hospital. |
| P394 | OPPORTUNISTIC EVENTS IN THE ERA OF HAART: A PERSPECTIVE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P394 AIDS 2000, Oct 22-26;14(Suppl. 4);S130 J. Contarelli, L. Massera, M. Michaan, G. Alberich, S. Ramírez, C. Costanzo and V. Oroz HAART significantly improve time and quality survival with high level of CD4 cell count and viral load undetectable or below 10,000 copies. Early detection of HIV status and treatment should be encouraged in our country because OE is the first manifestation of HIV infection in many people. |
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11 OPPORTUNISTIC INFECTIONS Abstracts P395 thru P402, Pages S126 TO S133 |
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| P395 | GENITAL BOWENOID PAPULOSIS AND HIV Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P395 AIDS 2000, Oct 22-26;14(Suppl. 4);S131 A. Klein, U. Juschka and M. Hartmann It appears that this treatment of genital bowenoid papulosis with imiquimod 5% offers an effective alternative to the more aggressive methods previously in use. |
| P396 | EFFICACY OF LEVAMISOLE AND CIMETIDINE IN THE TREATMENT OF RECALCITRANT FACIAL WARTS IN AN HIV-POSITIVE PATIENT ON POTENT ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P396 AIDS 2000, Oct 22-26;14(Suppl. 4);S131 R. Lau, F. Davidson, J. Mantell and P. Hay The efficacy of levamisole appears to be related to its immunomodulatory activity [3,4] and further studies should be pursued to assess its role as a T-cell adjuvant in combination with antiretroviral regimens. |
| P397 | LIFE-SAVING CHEMOTHERAPY FOR KAPOSI’S SARCOMA IN A HIV POSITIVE PREGNANT WOMAN Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P397 AIDS 2000, Oct 22-26;14(Suppl. 4);S131 E. McGrath, S. Clarke, C. McMahon, F. Mulcahy and C. Bergin This case demonstrates a failure of KS regression with a successful HAART regimen. It also reiterates the difficulties associated with the management of a malignancy in pregnancy. |
| P398 | A MULTIDRUG RESISTANT ORAL CANDIDA GLABRATA INFECTION IN AN AIDS PATIENT EFFECTIVELY TREATED WITH VORICONAZOLE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P398 AIDS 2000, Oct 22-26;14(Suppl. 4);S131 R. Colebunders, E. Florence, I. Vreelust, D. Swinne and A. Noe Voriconazole seems to be a promising antifungal drug for patients with fluconazole and itraconazole resistant candida infections. This new treatment is able to improve considerably the quality of life of patients for which so far amfotericine B IV was the only treatment option. |
| P399A | A CASE SERIES AND LITERATURE REVIEW OF ENTEROBACTER SPP. INFECTION COMPLICATING HIV DISEASE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P399A AIDS 2000, Oct 22-26;14(Suppl. 4);S132 R. Manfredi1, A. Nanetti2, M. Ferri2 and F. Chiodo1 Only 34 episodes of HIV-associated Enterobacter spp. infection have been reported to date in 11 different literature studies (14 cases of sepsis, 18 of pneumonia, and one case each of urinary tract infection and osteomyelitis), but all of them were recorded within large studies of HIV-related bacterial complications, and therefore lack of detailed information. Our experience therefore presents the largest series of HIV-associated Enterobacter spp. disease, and reports the greatest number of cases of urinary tract involvement in the setting of HIV infection. Our data point out that Enterobacter spp. have an appreciable pathogenic potential in HIV-infected patients, especially when a low CD4+ lymphocyte count, neutropenia, and hospitalization are of concern. Despite the unpredictable susceptibility profile of these organisms, Enterobacter spp. disease may be favorably managed through a rapid identification and a timely and appropriate antimicrobial treatment. |
| P399B | A SIGNIFICANT NUMBER OF UNINFECTED INFANTS CAN BE HIV RNA (FALSE) POSITIVE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P399B AIDS 2000, Oct 22-26;14(Suppl. 4);S132 C.M. Stainsby1, E.G.H. Lyall2, G.P. Taylor1, S. Galpin1, J.R. Clarke1, M.O. McClure1 and J.N. Weber1 12/138 and 11/138 samples tested positive for HIV RNA, using the ST CV of 1000 µl and 250 µl respectively. Only two of these results were true positives with much higher copy number. Only 1/18 samples from infants with paired samples was HIV positive. This high false positive rate of HIV-RNA testing in infant plasma has implications not only for infants and parents who may be given erroneous results, but also for low positive HIV-RNA levels in patients on treatment with ‘viral rebound’ as well as those under investigation for acute seroconversion. |
| P400 | BACTERIOLOGICAL SURVEILLANCE OF SEPSIS–BACTERAEMIA AS A COMPLICATION OF HIV DISEASE: A BASIS FOR THERAPEUTIC MANAGEMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P400 AIDS 2000, Oct 22-26;14(Suppl. 4);S132 R. Manfredi1, A. Nanetti2, R. Valentini2, and F. Chiodo1 Empiric treatment of HIV-related bacterial complications should include glycopeptides or netilmicin when staphylococci are of concern, and ureidopenicillins or glycopeptides when enterococci or streptococci are suspected. Enteric Gram-negative organisms usually require second- or third-generation cephalosporins, aminoglycosides or systemic quinolones, while piperacillin, tobramycin, amikacin or quinolones are reliable when Pseudomonas and related organisms are of concern. |
| P401 | HIV-ASSOCIATED NOSOCOMIAL PSEUDOMONAS SPP. DISEASE: A RETROSPECTIVE CASE–CONTROL STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P401 AIDS 2000, Oct 22-26;14(Suppl. 4);S133 R. Manfredi1, A. Nanetti2, M. Ferri2, and F. Chiodo1 A number of potential predisposing factors has been demonstrated for Pseudomonas spp. infection occurring in the immunocompromised host, but a variable rate of nosocomial disease and associated risk factors has been shown by different literature surveys in the setting of AIDS. Our experience points out that significantly different epidemiological and clinical features underlie hospital-acquired Pseudomonas spp. disease compared with communityacquired one, therefore prompting careful attention by clinicians and microbiologists caring for hospitalized HIV-infected patients at risk for severe bacterial disease. |
| P402 | ESTIMATION OF THE PREVALENCE OF ΔF 508 HETEROZYGOSITY IN HIV INFECTED PATIENTS WITH PSEUDOMONAS AERUGINOSA PULMONARY INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P402 AIDS 2000, Oct 22-26;14(Suppl. 4);S133 C. Orkin1, J. Morlese1, A. Buckingham2, B. Gazzard1 and D. Asboe1 The prevalence of CFTR gene mutations in HIV-1 infected patients with Pseudomonas aeruginosa pulmonary infection was not different from the general population. Although the confidence intervals were wide this suggests that these infections are not associated with increased prevalence of ΔF 508 or other mutations associated with cystic fibrosis. |
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12 TUMOURS Abstracts P403 thru P409, Pages S133 TO S135 |
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| P403 | AN ASSOCIATION OF DISSEMINATED MYCOPLASMA FERMENTANS IN HIV-1 POSITIVE PATIENTS WITH NON-HODGKIN’S LYMPHOMA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P403 AIDS 2000, Oct 22-26;14(Suppl. 4);S133 J.G. Ainsworth, P.J. Easterbrook, J. Clarke, C.B. Gilroy and D. Taylor-Robinson The data suggest an association between the haematogenous dissemination of M. fermentans and the occurrence of NHL in HIV-positive patients. This finding needs confirmation in other established cohort studies of HIV-positive patients or in case-control studies. |
| P404 | DECREASING INCIDENCE OF NON-HODGKIN LYMPHOMA (NHL) IN THE ERA OF HAART. THE EUROSIDA STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P404 AIDS 2000, Oct 22-26;14(Suppl. 4);S133 O. Kirk1, A. Mocroft2, F. Antunes3, C. Pedersen4, P. Skinhøj5, V. Miller6, A. Lazzarin7, J.M. Gatell8, S. Barton9 and J.D. Lundgren1 In conclusion, the incidence of NHL has decreased significantly after the introduction of HAART and most pronouncedly among patients with severe immunodepression. Whether the risk of NHL will decrease further after more extended treatment with HAART awaits confirmation. |
| P405 | REMISSION OF ANAPLASTIC LARGE CELL LYMPHOMA BY HIGHLY ACTIVE ANTIRETROVIRAL THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P405 AIDS 2000, Oct 22-26;14(Suppl. 4);S134 M. Oette, A. v. Herbay, T. Kaden, A. Theisen, A. Kroidl, M. Wettstein and D. Häussinger The case shows that highly active antiretroviral therapy is capable of inducing a complete remission of anaplastic large cell lymphoma. Thus, HAART should be the first step of therapy in cases of anaplastic large cell lymphoma. Unfortunately, our patient died of liver disease. This shows the limitations of therapy, where toxicity counteracts the success. |
| P406 | EVALUATION OF 310 PATIENTS FOR AIDS-RELATED LYMPHOMA DURING A FOUR-YEAR PERIOD IN AN ATHENS AIDS UNIT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P406 AIDS 2000, Oct 22-26;14(Suppl. 4);S134 U. Georgiou1, A. Lioni1, P. Potamousi1, S. Giannakopoulou1, E. Papadomichelakis1, J. Boutsikakis1, D. Rontogianni3, V. Kapsimali2 and G. Saroglou1 All patients had disseminated disease (stage IV) and four of them (66.6%) had B-symptoms. All patients were treated with combination chemotherapy and HAART, while in three patients radiotherapy was added. Five of six patients experienced severe myelotoxicity and support with GcSF was necessary. Two patients had complete response of disease, two patients had partial response, one patient no response and for one patient there is no data yet. Three patients died and the median survival was 10.6 months. The prognosis for patients with AIDS-related lymphomas is poor. None of our patients was in HAART when the diagnosis of lymphoma made. In this 4-year period none of our patients while in HAART developed lymphoma. We believe that further follow-up and larger patient population will be required to determine the precise incidence of systemic lymphoma in HAART- treated individuals. |
| P407 | UNUSUAL MALIGNANT TUMOURS IN ASSOCIATION WITH HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P407 AIDS 2000, Oct 22-26;14(Suppl. 4);S134 J. Santos, R. Palacios, R. Soriano, J. Ruiz, M. González, M. Márquez Our results suggest that HIV infected patients have a higher risk of malignant tumours such as Hodgkin’s disease and lung cancer. Squamous cell carcinoma is the most frequent histological type among UMT in these patients. Some of these tumours lead to an important mortality and a shortened survival in HIV patients. Clinicians should consider performing HIV antibodies in young patients or with HIV risk factor who present a malignant tumour. |
| P408 | A PRACTICAL APPLICATION OF MOLECULAR BIOLOGY: RESPONSE OF A PATIENT WITH CASTLEMAN’S DISEASE AND MICROLYMPHOMA TO MONOCLONAL ANTIBODY THERAPY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P408 AIDS 2000, Oct 22-26;14(Suppl. 4);S135 R.W. Baker, G. Matthews, M. Bower, M.R. Nelson, A.L. Pozniak and B.G. Gazzard IL-6 is a biologically inert molecule that requires binding with a specific soluble receptor and gp130 to become active. Monoclonal antibodies to the soluble receptor will prevent its activation. Conditions driven by excess of IL-6 may therefore be suppressed by treatment with sIL-6R antibody. While it is not possible to categorically assert that improvement in one individual was due to monoclonal antibody therapy, we believe that this may offer a novel therapeutic approach for Castleman’s disease. It may also have implications for other HHV8/IL-6 driven disorders, such as Kaposi’s sarcoma. |
| P409 | RESPONSE OF CUTANEOUS AIDS–KAPOSI SARCOMA (KS) TO HIGHLY ACTIVE ANTIRETROVIRAL TREATMENT (HAART) ALONE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P409 AIDS 2000, Oct 22-26;14(Suppl. 4);S135 V.A. Paparizos, K.P. Kyriakis, C.A. Botsi, V. Papastamopoulos, M. Hadjivassiliou, N.G. Stavrianeas and A.D. Katsambas Cutaneous KS in early stages can possibly be managed with HAART only. This might prevent the side effects and the cost of cytostatic therapy. |
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13 GLOBAL TREATMENT, DISEASE AND RESOURCE ISSUES Abstracts P410 thru P426, Pages S135 TO S140 |
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| P410 | ADMISSION TO HOSPITAL IN THE HAART ERA. THE EuroSIDA STUDY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P410 AIDS 2000, Oct 22-26;14(Suppl. 4);S135 N. Friis-Møller1, O. Kirk1, A. Mocroft2, J.N. Bruun3, A. Johnson4, R. Colebunders5, R. Proenca6, J. Gonzalés-Lahoz7, A. D’ Arminio Monforte8 and J.D. Lundgren1 In conclusion, the decrease in incidence and duration of hospital admissions for the period 1996 to 1999 reflects the overall improved health of the HIV-infected population since the introduction of HAART. In addition to HIV-related factors, being female and older was associated with a higher risk of admission to hospital in 1999. Further analyses to identify changes in risk factors are warranted. |
| P411A | EVOLUTION OF ANTIRETROVIRAL THERAPY, HEALTH RESOURCE UTILIZATION, AND EFFECTS ON THE EPIDEMIOLOGICAL TRENDS OF AIDS: A SIX-YEAR SURVEY IN NORTHERN ITALY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P411A AIDS 2000, Oct 22-26;14(Suppl. 4);S135 R. Manfredi and F. Chiodo Our experience remarks the considerable impact of the extensive use of HAART on health care expenditures, and the early consequences on trends of disease progression, as established by monitoring the key clinical end-points of HIV infection. Long-term pharmacoeconomic analyses considering the rising costs for both treatment and laboratory follow-up and the already obtained reduction of inpatient care are needed, in order to plan health resource allocation in the future. |
| P411B | THE DISTRIBUTION OF OVERALL AIDS-DEFINING OPPORTUNISTIC INFECTIONS AND THE CONCURRENT LEVEL OF IMMUNODEFICIENCY SHOWED LIMITED CHANGES SINCE THE INTRODUCTION OF HAART Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P411B AIDS 2000, Oct 22-26;14(Suppl. 4);S135 R. Manfredi, L. Calza and F. Chiodo In conclusion, the availability of HAART does not seem to act significantly on the distribution of AIDS-defining OI in newly diagnosed patients, so that the clinician caring for patients with untreated or suspected HIV infection should maintain careful attention for immunodeficiency-related opportunism. |
| P412 | LONGITUDINAL ASSESSMENT OF QUALITY OF LIFE IN A COHORT OF ITALIAN SEROPOSITIVE PATIENTS IN TREATMENT FOR AT LEAST 6 MONTHS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P412 AIDS 2000, Oct 22-26;14(Suppl. 4);S136 M. Martini1, R. Bucciardini2, F. Paolettis3, A. Brandi3, C. Lesmo1, A. Cargnel4, G. Carosi5, F. Mazzotta6, V. Agnoletto1 Particular events, behaviours, psychological conditions, health status, clinical condition and other factors may affect quality of life of seropositive patients. The study will attempt to evaluate the role of other items, not included in MOS HIV questionnaire, as possible determinants of the QoL of patients. |
| P413 | RATES OF CHANGE OF COMBINATION ANTIRETROVIRAL TREATMENTS IN AUSTRALIA, 1997–2000 Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P413 AIDS 2000, Oct 22-26;14(Suppl. 4);S136 M.G. Law on behalf of The Australian HIV Observational Database A total of 864 participants in the AHOD commenced combination antiretroviral treatment after 1 January 1997 (96% male, 81% homosexual contact, mean age = 39 years). Median CD4 count at commencement was 350 cells/µl, and median HIV viral load 26,543 copies/ml. The overall rate of new combination antiretroviral treatments after the first combination was 1.0/year of follow up. Rates of combination antiretroviral treatments were higher for females (Rate ratio (RR) = 1.39, P = 0.004) and in people who commenced treatment with a CD4 count < 200 cells/μ1 (RR = 1.22, P = 0.002). Rates were not statistically significantly different by viral load (< 25,000 copies/ml versus ≥ 25,000 copies/ml), exposure category, age group or previous AIDS defining illness. These analyses indicate that there is a rapid rate of change of combination antiretroviral treatments in Australia. |
| P414 | MODIFICATION OF DEMOGRAPHIC CHARACTERISTICS, CLINICAL PRESENTATIONS AND OUTCOME IN A 15 YEAR-OBSERVATIONAL COHORT OF 437 AIDS PRESENTING PATIENTS Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P414 AIDS 2000, Oct 22-26;14(Suppl. 4);S137 B. Castelnuovo, C. Abell, T. Bini, L. Testa, E. Chiesa, S. Meizi, M. Bongiovanni, S. Sollima, A.L. Ridolfo, M. Moroni and A. d’ Arminio Monforte Heterosexually infected patients, mostly females, are still at high risk of AIDS due to unawareness of their HIV-positive status. |
| P415 | CHANGING DEMOGRAPHICS OF AN IRISH HIV-INFECTED COHORT FROM 1995 TO 1999 Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P415 AIDS 2000, Oct 22-26;14(Suppl. 4);S137 M. Ryan, S. Clarke, L. McCullagh, C. Merry, M. Barry and F. Mulcahy Reasons for these changes in demographic characteristics of new attendees may include: a change in policy by the National Haemophilia Centre to refer haemophilacs to our clinic for HIV care; increased HIV testing of young IDUs by the Drug Treatment Service subsequent to centralisation of methadone maintenance in the latter half of 1998; Ireland’s recently increasing refugee population, and adoption of a national ante-natal HIV screening program in 1998. This study illustrates changing demographic patterns amongst new attendees and facilitates adaptation of the healthcare and support services provided by our clinic to the changing needs of our patient cohort. In particular the needs of our increasing numbers of women, young IDUs and non-nationals for whom English is not a first language are being addressed. |
| P416 | INTEGRATING TREATMENTS SUPPORT WITHIN A GENERALIST HIV VOLUNTARY ORGANISATION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P416 AIDS 2000, Oct 22-26;14(Suppl. 4);S137 M. Phillips, L. Power and J. Williams The work has shown that core services can work alongside regional variations and that treatments support can be addressed flexibly in agencies of varying sizes and target populations. |
| P417 | HIV HOME CARE SERVICES IN KIGUNGU VILLAGE IN UGANDA Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P417 AIDS 2000, Oct 22-26;14(Suppl. 4);S137 Matilda Namuyimbwa Nsumba Abstract not reproduced at Author’s request |
| P418 | COMMUNITY’S ROLE IN ACCESS TO TREATMENT AND CARE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P418 AIDS 2000, Oct 22-26;14(Suppl. 4);S138 Mpiima Jamada This therapy given a month before delivery and during labor is 50% effective. This shorter period is advantageous in terms of efficiency, cost effectiveness and compliance. People infected with HIV need information about drugs and need to network with drug companies so as to access these drugs at a subsidized cost. |
| P419 | COMPLEMENTARY USE OF NATURAL THERAPIES IN HIV CARE: ARE PATIENTS AWARE OF POSSIBLE RISKS OF INTERACTIONS WITH ANTIRETROVIRAL DRUGS? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P419 AIDS 2000, Oct 22-26;14(Suppl. 4);S138 P. Nasta1, V. Agnoletto1, M. Martini1, E. Recchia1, L. Hollander, M.C. Eggermont2, F. Rodenbourg3, X. Garcia4, C. Mann5 and H.J. Linkens6 82.2% of respondents reported the absence of any adverse effect. ELECTHIV results show that patients underestimate the risk of interactions between NATC and antivirals, which on the contrary has proved to represent a serious problem. This leads to stress the need to improve the communication between patients and doctors as concerns complementary treatments, as well as the information of both doctors and NATC practitioners on the possible implications of their use, in order to ensure a correct approach to a range of treatments with a significant potential to improve the well-being of people with HIV. |
| P420 | FINANCIAL DIFFICULTIES FOR PEOPLE LIVING WITH HIV IN EUROPE Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P420 AIDS 2000, Oct 22-26;14(Suppl. 4);S138 C. Dreezen, W. Schrooten, J. Cobena, J. Soletti, V. Van Wijk and R. Colebunders on behalf of the Eurosupport II Group The financial burden of PLWH in Europe has improved over time for essential needs since the introduction of HAART, although the financial situation of these people is far from ideal. |
| P421 | THE ACTIVE MANAGEMENT OF HIV IN PREGNANCY Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P421 AIDS 2000, Oct 22-26;14(Suppl. 4);S138 S. Clarke1, K. Butler2, C. Bergin1, G. Sheehan3, M. Morgan4, F. Mulcahy1 To date there are 57 infants (35 male, 22 female), with a mean weight of 3.05 kg (1.16–3.82 kg). The mean gestational age at delivery was 39.4 weeks (range 31–42 weeks). Twenty-two infants have seroreverted and are HIV antibody negative. 35 infants remain antibody positive (all less than 18 months old), however all of this group have at least one negative HIV PCR RNA result, 19 having at least two negative results. There have been two infant deaths, one sudden infant death, one cervical cord tumour. Two infants have shown congenital anomalies with one hypospadias and one unilateral simian crease. A third infant had bilateral inguinal hernia repaired in the first week. HAART has shown to be efficacious and well tolerated in pregnancy. Results from this study will enable guidelines for the management of HIV in pregnancy to be redressed. |
| P422 | AT WHAT STAGE OF HIV INFECTION ARE INDIVIDUALS FROM ETHNIC MINORITIES DIAGNOSED? Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P422 AIDS 2000, Oct 22-26;14(Suppl. 4);S139 S. King and C. Rodgers Despite health education campaigns and improved awareness of the potential of HAART, patients from black ethnic minorities continue to present at a later stage of HIV diagnosis than white. The reasons for this require further investigation, but to maximise the potential of HAART more efforts are needed to encourage these patients to present to health care services sooner. |
| P423 | THE CHANGING PATTERN OF ORAL MANIFESTATIONS OF HIV INFECTION Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P423 AIDS 2000, Oct 22-26;14(Suppl. 4);S139 P. Benn1, A. Copas2, I.Williams2 and J. Zakrzewska3 The results highlight a reduction in the proportion of patients presenting with OC, OHL and periodontal disease (after controlling for CD4) to this specialist clinic since the introduction of more effective antiretroviral therapy. Surprisingly we saw no reduction in the proportion of patients presenting with oral KS lesions, however numbers are small and the proportion of patients with oral warts appears to have increased in this clinic population. |
| P424 | QUALITY OF CARE IN HIV. PATIENT’S OPINION AND PHYSICIAN’S ASSESSMENT Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. P424 AIDS 2000, Oct 22-26;14(Suppl. 4);S139 J. Locutura1, P. Viciana2, J.M. Miró3, E. Ortega4, A. Antela |