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