This pilot, open-label, single-center trial is designed to evaluate the safety, tolerance, CD4+ cell response, viral load (in plasma, cerebrospinal fluid and intestinal tissue) reduction, and durability of viral load reduction of long-term quadruple antiretroviral therapy, using zidovudine (ZDV), epivir (3TC), 1592U89 and 141W94. Additionally, the study will enable determination of rates of decay of HIV in gut-associated lymphoid tissue (GALT) and cerebrospinal fluid, providing an understanding of the decay characteristics of HIV replicates in viral reservoirs other than peripheral blood. Twenty-four HIV-1 subjects will be studied: 12 with acute (within 90 days) infection and 12 with chronic infection. The initial duration of the study is 24 weeks. Based on review of ongoing toxicology studies, agreement with the sponsor and FDA, and contingent upon IRB approval, the treatment duration will extended to 48 weeks. If the safety profile of the four-drug combination remains acceptable, and contingent upon agreement with the sponsor and the FDA and approval of the IRB, the treatment duration may be extended indefinitely.
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