Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients.

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Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients.

AIDS. 1996 Aug;10(9):975-81. Unique Identifier : AIDSLINE MED/97006437
Kuritzkes DR; Quinn JB; Benoit SL; Shugarts DL; Griffin A; Bakhtiari M; Poticha D; Eron JJ; Fallon MA; Rubin M; Division of Infectious Diseases, University of Colorado Health; Sciences Center, Denver 80262, USA.

Abstract: OBJECTIVE: To study the effect of HIV-1 resistance to lamivudine (3TC) and zidovudine (ZDV), and syncytium-inducing (SI) phenotype on virologic response to treatment with ZDV, 3TC, or ZDV plus 3TC in previously untreated individuals with HIV-1 infection. DESIGN: A prospective virologic substudy of GlaxoWellcome protocol NUCA 3001. METHODS: HIV-1 isolates obtained at study entry and at week 12 were expanded in peripheral blood mononuclear cell (PBMC) culture, titered, and assayed for phenotypic and genotypic evidence of resistance to ZDV and 3TC, and for syncytium formation on MT-2 cells. RESULTS: Phenotypic and genotypic resistance to 3TC was detected in the majority of HIV-1 isolates from patients who received 3TC alone or in combination with ZDV. Despite showing 3TC resistance, subjects who received 3TC in combination with ZDV had significantly greater decreases in plasma HIV-1 RNA levels compared with those who received ZDV alone. Occurrence of the K7OR ZDV resistance mutation was significantly reduced in patients who received the 3TC/ZDV combination as compared with patients on ZDV monotherapy. Plasma HIV-1 RNA returned to near-baseline levels more quickly in patients with SI isolates at study entry. CONCLUSIONS: Despite the rapid emergence of 3TC resistance, combination therapy with 3TC plus ZDV resulted in greater reduction in plasma HIV-1 RNA levels over 24 weeks as compared to ZDV monotherapy. Prevention of ZDV resistance may contribute to the sustained activity of the combination therapy.

Keywords: Adult Anti-HIV Agents/*PHARMACOLOGY/THERAPEUTIC USE Comparative Study Double-Blind Method Drug Resistance Drug Therapy, Combination Female Genes, Viral Human HIV Infections/*DRUG THERAPY HIV-1/*DRUG EFFECTS/ISOLATION & PURIF/PHYSIOLOGY Lamivudine/*PHARMACOLOGY/THERAPEUTIC USE Male Mutation/DRUG EFFECTS Support, Non-U.S. Gov't Virus Replication Zidovudine/*PHARMACOLOGY/THERAPEUTIC USE CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL
970330
M9731502

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