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NLM AIDSLINE

Improved survival and decreased progression of HIV in patients treated with saquinavir (Invirase, SQV) plus HIVID (zalcitabine, ddC).




 

Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):29 (abstract no.

Objective: To compare the safety, tolerability and efficacy of SQV plus ddC, compared to ddC or SQV alone. Methods: In this double-blind, multicentre, phase II/III study, HIV infected patients with a CD4 lymphocyte count of 50-300 cells/mm(3), and greater than or equal to 16 weeks of prior ZDV therapy, were randomized to receive ddC 0.75 mg q8h, SQV 600 mg q8h, or SQV 600 mg + ddC 0.75 mg q8h. Results: The patients in the intent to treat analysis (N=940) were balanced across the treatment arms with respect to sex, age, race, baseline viral load (median 5.1-5.2 log copies/ml), baseline CD4 count (median 160-180 cells/mm(3), and reason for discontinuing prior ZDV. Duration on initial treatment was shorter for patients on ddC, but follow-up was similar for all arms (median 73-74 weeks). (Table: see text) For both time to first AIDS-defining event or death, and for survival alone, there were statistically significant benefits of combination SQV + ddC over ddC. There were no significant differences in the comparisons of SQV to ddC. (Table: see text) A prior analysis of surrogate markers and safety in the first 423 patients out to week 48 established the safety profile of SQV, which was well tolerated alone and in combination. A full safety report from this study will be completed later in the year. Conclusions: Clinical progression to first AIDS defining event or death, and survival alone, were prolonged in the SQV + ddC group compared to those on ddC alone.

*Anti-HIV Agents/THERAPEUTIC USE *HIV Infections/DRUG THERAPY *Saquinavir/THERAPEUTIC USE *Zalcitabine/THERAPEUTIC USE



 




Information in this article was accurate in September 30, 1997. 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.