AEGiS-07CROI: Improvement of lipodystrophy in HIV-1 infected subjects switching from 2NRTI/PI to 2NRTI/abacavir (French substudy, CNA30017).

7th Conference on Retroviruses and Opportunistic Infections

San Francisco, CA - January 30 -February 4, 2000

IMPROVEMENT OF LIPODYSTROPHY IN HIV-1 INFECTED SUBJECTS SWITCHING FROM 2NRTI/PI TO 2NRTI/ABACAVIR (FRENCH SUBSTUDY, CNA30017).

Conf Retroviruses Opportunistic Infect 2000 Jan 30-Feb 2; 7:84 (abstract no. 47)

W. Rozenbaum^1‚2, J. M. Molina², J. F.Delfraissy², M. Bentata², P. De Truchis², and Z. Antoun³
¹Rothschild Hosp.; ²Assistance Publique–Hôpitaux de Paris; ³GlaxoWellcome, France

OBJECTIVE: To compare metabolic and morphologic anomalies for 2NRTI/abacavir Vs continued 2NRTI/PI

METHODS:CNA30017 is an ongoing,international, randomised study evaluating the efficacy and tolerance of 2NRTI/abacavir(ABC) Vs continued 2NRTI/PI for>6 months with no virological failure (HIV-RNA<50cop/ml) since initiation of ART therapy. Patients (pts) were randomised to continue current treatment (PI) or switch PI to ABC. In France, a substudy was conducted, evaluating lipid, glucose and insulin levels and morphologic (skin folds, body circumference) anomalies at D1, week 4, 12, 24, 36, and 48.

RESULTS: 32 pts were included (ABCn=16,14M:2F; PIn=16,11M:5F) and followed-up until week 12. Prior NRTI for ABC Vs PI groups were Combivir 11Vs7,3TC 4Vs8,ZDV 3Vs2,d4T 2Vs7 and ddI 1Vs1. Median CD4+ cell count was 604Vs564 c/mm³ at baseline.Median change in triglycerides (TG) between week 12 and D1 respectively for ABC Vs PI groups was -0.06 mmol/l Vs 0.245 (p=0.33) and for cholesterol was -0.57mmol/l Vs -0.43 (p=0.42). There was no difference in baseline and in week 12 median serum glucose between both groups. However, the OGTT, similar at baseline for ABC and PI, becomes significantly higher (p=0.048) at week 12 with a median glucose level of 6.71 mmol/l for PI Vs 4.77 mmol/l for ABC. There was no significant difference in skin folds measurements between both groups, but a significant increase in chest circumference of 1 cm in PI Vs 0 cm in ABC (p=0.03) at week 12. However, no significant difference was found for hip, waist and weight measurements between both groups. 53% (17/32) of pts had abdominal hypertrophy (AH) at baseline, 9 in ABC and 8 in PI. At week12, 5 in ABC group and 3 in PI group reported resolution of AH. 7/32 pts (ABC:3, PI:4) had lower limb atrophy at D1. These signs resolved at week 12 for 3 pts in ABC and 1 pt in PI. 7/32 pts (ABCn=4;4M;PIn=3;3F) had gynecomastia at baseline that resolved for 3 pts in ABC group and none in PI.

CONCLUSION:Preliminary week 12 results show that pts in the PI group continue to experience TG elevations, glucose intolerance and clinical signs of lipodystrophy. Whereas, stabilisation of TG level and improvment of glucose metobolism and of some morphologic anomalies are observed in ABC group.

Keywords: AEGIS, Dideoxynucleosides, Lipodystrophy, HIV-1, CD4 Lymphocyte Count, Reverse Transcriptase Inhibitors, Diabetes Mellitus, Lipoatrophic, Zidovudine, Lamivudine, Anti-HIV Agents, HIV Protease Inhibitors, HIV-1 Reverse Transcriptase, Triglycerides, Stavudine, France, abacavir, Combivir, Male, Human, AIDS

2000-01-30
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Copyright © 2000 - Foundation for Retrovirology and Human Health (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed from National Library of Medicine.