This randomized, controlled, open-label multi-center trial is designed to compare the intracellular delay in onset of suppression of HIV-1 viral replication within the first 72 hours of initiation of antiretroviral therapy using indinavir, or nevirapine, or combination zidovudine(ZDV)/3TC. All subjects receive four-drug combination therapy from 72 hours forward. Additionally, the trial evaluates whether (GM-CSF and IL-12) cytokines which stimulate the proliferation and activation of monocytes and macrophages, when added to antiretroviral therapy, can hasten the clearance of HIV from these cells. The study also measures several aspects of T cell recovery. Twenty-four HIV-1 infected subjects will be enrolled in total; 8 will be enrolled at the Rockefeller GCRC. All will be naove to prior antiretroviral therapy, and will have been HIV-1 infected for at least 6 months. The study duration is 72 weeks. If preliminary results suggest a significant increase in the clearance rate of HIV-1 and the sponsor (ACTG), the FDA and IRB approve, the study may be amended to extend immune modulation.
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