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Further results from European/Australian delta trial.




 

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



 




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.