INITIAL THERAPY FOR HIV-I INFECTION (ACTG A5142)

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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. Protocol Objectives and Main Hypotheses: To compare the time to virologic failure pair wise between the three treatment groups for HIV Infection: Lopinavir/ritonavir plus efavirenz, lopinavir/ritonavir plus 2 NRTIs, and efavirenz plus 2 NRTIs. To compare the time to regimen completion pair wise between the three treatment groups: Lopinavir/ritonavir plus efavirenz, lopinavir/ritonavir plus 2 NRTIs, and efavirenz plus 2 NRTIs. Regimen completion will be defined as either virologic failure or toxicity-related discontinuation of any component of the initial randomized treatment regimen. The use of lopinavir/ritonavir in this study will allow a direct comparison of the efficacy and durability of PI-versus NNRTI-based initial therapy. The lopinavir/ritonavir plus efavirenz combination will provide an important, concurrent comparison of the ARV activity and toxicity of an NRTI-sparing regimen. Important metabolic issues will be addressed prospectively. The patterns of resistance observed following virologic failure with these regimens will be characterized. (ACTG A5142)