3rd Conf Retro and Opportun Infect. 1996 Jan 28-Feb 1;:161. Unique

Design and population: HIV infected individuals with ARC or AIDS or a CD4 count less than 350 microliters were eligible for Delta 1 if they were AZT-naive or Delta 2 if they had had AZT for at least 3 months. Participants were randomised to either AZT alone or to a combination of AZT + ddl or AZT + ddC. Between 3/92 and 4/94 a total of 2131 (Delta 1) and 1083 (Delta 2) were allocated and prescribed trial therapy. At baseline, 12% in Delta I and 17% in Delta 2 had AIDS and the mean CD4 counts were 213 and 189/microliters respectively. In Delta2 65% had taken AZT for more than 1 year. Survival and disease progression: Data to 31/5/95 (median follow-up of 26m in both trials) showed a substantial and significant advantage in survival and disease-free survival to the combination regimens in Delta 1 (relative reduction of 38% for mortality and 31% for a progression to AIDS or death) but not in Delta 2; a combined analysis showed a relative reduction in mortality of about 25% (p=0.001). The survival difference only appeared to emerge after 18 months of follow-up. Changes in CD4 cell counts were significantly different between the groups with the largest effect in the AZT/ddI group and smallest in the AZT alone. Adverse events: All three regimens were reasonably well tolerated. In both Delta 1 and 2, nausea and vomiting were more common in the AZT/ddI and AZT/ddI placebo groups. Peripheral neuropathy and mouth ulcers were more common in the AZT/ddC group. The International Co-ordinating Committee is grateful to all participants, clinicians and their teams and to everyone else who contributed to Delta.

Antiviral Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE CD4 Lymphocyte Count Didanosine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Drug Therapy, Combination Human Zalcitabine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Zidovudine/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE ABSTRACT