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NLM AIDSLINE

Potent and sustained antiretroviral activity of indinavir(IDV) in combination with zidovudine (ZDV) and lamivudine (3TC).




 

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



 




Information in this article was accurate in November 30, 1996. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.