ACTG A5142: A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON OF LOPINAVIR/

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Critical assessment of the role of newer treatement strategies and drugs as they become available and their role in management of HIV-1 infection is essential. ACTG A5142 is a phase III, randomized, three-arm, open label study comparing the effectiveness of an NNRTI-based regimen (efavirenz + stavudine extended release or zidovudine + lamivudine), a ritonavir-enhanced PI-based regimen (lopinavir/ritonavir + stavudine extended release or zidovudine + lamivudine) and an NRTI-sparing regimen (efavirenz + lopinavir/ritonavir) for the initial treatment of HIV infection. This study will look at the role of lopinavir/ritonavir, a ritonavir-enhanced second generation PI, and an NRTI-sparing regimen, which are not being addressed adequately in current research. The study will enroll 660 HIV-1, antiretroviral male and female subjects having a viral load equal to or greater than 2000 copies/mL. This is a 96-week study; subjects will continue on study until the last subject enrolled completes 96 weeks. There are three steps to the study. Step 1 is randomization to initial study regimens at study entry. Subjects with a toxicity to a single drug on Step 1 who substitute a single, within-class drug will register to Step 2. Subjects on Step 1 or 2 who develop virologic failure or a treatment-limiting toxicity will register to Step 3.