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