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. A5142 is a phase III, randomized, three-arm, open-label study comparing the effectiveness of the following regimens for the initial treatment of HIV infection: 1. Nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen (efavirenz [EFV] plus Stavudine extended release [d4T XR] or zidovudine [ZDV} of Tenofovir disoproxil fumarate [TDF] plus lamivudine [3TC]) 2. Ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen (lopinavir/ritonavir [LPV/RTV] plus d4T XR [or ZDV or TDF] plus 3TC) 3. Nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen (EFV plus LPV/RTV) The primary objectives are to compare the time to virologic failure pairwise between the three treatment groups, and to compare the time to regimen completion between the three treatment groups. Regimen completion will be defined as either virologic failure or toxicity-related discontinuation of any component of the initial randomized treatment regimen. Secondary objectives include comparing between the three treatment arms the occurrence of peripheral lipoatrophy (fat wasting) as measure by limb DEXA, and to compare between the treatment groups the following metabolic abnormalities: hyperlactatemia, truncal fat accumulation, hypercholesterolemia, hypertriglyceridemia, insulin resistance, and bone loss.
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