AEGiS-14IAC: MIV-310 reduces markedly viral load (VL) in patients (pts) with virologic failure despite multiple-drug therapy: results from a 4-week phase II study.

14th International AIDS Conference


Barcelona, Spain - July 7-12, 2002

DonateNow
Print this article

MIV-310 reduces markedly viral load (VL) in patients (pts) with virologic failure despite multiple-drug therapy: results from a 4-week phase II study.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPeB9027B)

Katlama C, Tubiana R, Ghosn J, Wirden M, Shoen H, Harmenberg J, Mardh G, Westling C, Calvez V
Hopital Pitie-Salpetriere - Service Maladies Infectieuses, Paris, France

BACKGROUND: MIV-310 (3'-deoxy-3'-fluorothymidine) is a nucleoside analogue RT inhibitor which exhibits potent in vitro efficacy against NRTI resistant viral strains.

METHODS: This phase II pilot study had included 15 pts failing a NRTI-containing regimen with HIV RNA > 1000 cp/ml, with at least 2 TAMs on genotypic assay. They were given MIV-310 7.5 mg qd in addition to their current regimen during 4 weeks. Evaluation was performed weekly and 4 weeks after MIV 310 stopping.

RESULTS: The 15 pts had a baseline (BL) VL of 3.93 log10 cp/ml, median CD4 cells of 360, median number of TAMs was 4 (range 2 to 5) with 100 % T215Y/F. The overall median reduction in VL after 4 weeks adding MIV 310 was - 1.13 log10 (n=15) with -1.88 log10 in pts with no D4T and -0.57 log10 with D4T suggesting an interaction between the 2 drugs. Decrease in HIV RNA was: -1.59 log10 in pts with 2 TAMS, -1.69 log10 in pts with 3 TAMS, -1.92 log10 in pts with 4 TAMS, -1.18 log10 in pts with 5 TAMS The results from the pts who did not receive d4T treatment are shown in Table 1. [table: see text] MIV-310 was generally well tolerated over this short period. There was no withdrawal from therapy and no serious adverse events were reported. A transient mean increase in CD4 counts of + 52 counts/mm3 was observed (n=15).

CONCLUSIONS: MIV-310 at 7.5 mg/day efficiently reduced VL in pts with virologic failure despite multiple resistance to NRTI. Further studies are being planned.

Keywords: AEGIS, Viral Load, CD4 Lymphocyte Count, Stavudine, HIV Infections, Anti-HIV Agents, HIV Protease Inhibitors, HIV, Pharmaceutical Preparations, Antiretroviral Therapy, Highly Active, Clinical Trials, Drug Therapy, Combination, In Vitro, Human, virology, drug therapy

020707
LbPeB9027B

Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.