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NLM AIDSLINE
Potent and sustained antiretroviral activity of indinavir(IDV) in combination with zidovudine (ZDV) and lamivudine (3TC).
Gulick R; Mellors J; Havlir D; Eron J; Gonzalez C; McMahon D; Richman D;
November 30, 1996
3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:162. Unique

Design: A randomized, double-blind study comparing IDV 800mg q8h + ZDV 200mg q8h + 3TC 150mg q12h or IDV 800mg q8h or ZDV 200mg q8h + 3TC 150mg q12h in 97 adult patients (pts) with HIV infection, greater than or equal to 6 months of prior ZDV therapy, 50-400 CD4 cells/mm3 and greater than 20,000 copies/ml of serum HIV RNA(Roche PCR kit assay). Results: After up to 32 weeks of study follow-up, one serious adverse event occurred, considered to be unrelated to study medications. Two patients on indinavir had nephrolithiasis, both of whom were able to continue without dose reduction. Neutropenia and/or anemia requiring ZDV and 3TC dose reduction occurred. Preliminary pharmacokinetic data show no clinically significant interactions among the study medications. A summary of available viral load data is shown below:(Table: See Text). This corresponds with median HIV RNA log10 declines (setting lower limit to 500 copies RNA) of -2.0 (IDV+ZDV+3TC), -1.3 (IDV), and -1.0 (ZDV+3TC) at 24 weeks. A summary of median CD4 change from baseline(cells/mm3) at 12 ([approx]28 pts/arm) weeks and 24 ([approx]10 pts/arm) weeks shows: +79 and +146 (IDV+ZDV+3TC), +98 and +77 (IDV) and +17 and +22 (ZDV+3TC). Conclusions: IDV+ZDV+3TC is a safe, well-tolerated regimen with potent antiretroviral activity and CD4 cell increases sustained for at least 24 weeks.

Antiviral Agents/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Double-Blind Method HIV Infections/*DRUG THERAPY HIV Protease Inhibitors/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE HIV-1/GENETICS/ISOLATION & PURIF Human RNA, Viral/BLOOD Zalcitabine/ANALOGS & DERIVATIVES/ADMINISTRATION & DOSAGE/ THERAPEUTIC USE Zidovudine/ADMINISTRATION & DOSAGE/THERAPEUTIC USE ABSTRACT

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