This is a four-arm study designed to determine the relative clinical efficacy of two regimens of combination nucleoside antiretroviral therapy, a regimen of monthly alternating nucleoside therapy, and a triple convergent combination therapy regimen for improving survival in HIV-infected persons with advanced disease and greater than 6 months prior nucleoside monotherapy. In March 1995, 1054 patients of the target 1292 patients had been enrolled. Withdrawal from the study medications continued to be a problem. 187 patients had died and another 253 had withdrawn from the study therapy. In May 1995, the Data and Safety Monitoring Board reviewed the data relating to toxicities and the primary endpoint (survival). Demographically, 49% of the patients were from communities of color with 11% female. The median baseline CD4 count was 199 and the mean CD4 count was 24. There were no recommendations for any change in the study at that time. In July 1195, 1205 patients of the target 1292 patients had been enrolled and over 900 clinical endpoints had occurred. In November 1995, the goal of 1292 participants was met and the study was closed to accrual. Patients accrued to the study will continue to be followed until September 1996.
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