COMPARISON OF INITIAL ANTRETROVIRAL REGIMENS

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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. A5202 is a phase IIIB, multicenter, randomized, four-arm study of initial therapy for HIV infection. It will compare the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced atazanavir (ATV) to efavirenz (EFV) (in combination with either daily emtricitabine [FTC]/tenofovir [TDF] or abacavir [ABC]/lamivudine [3TC]; and compare partially blinded FTC/TDF to ABC/3TC (in combination with either RTV-enhanced ATV or EFV). 1800 treatment-nanve subjects will be enrolled and followed for 96 weeks after the last subject enrolls; they will be evaluated in a standardized fashion for efficacy, safety, and tolerability. There are 3 optional substudies, including a metabolic substudy (A5224s) that requires use of the GCRC for dual-energy x-ray absorptiometry (DEXA) scans. The metabolic substudy will evaluate the metabolic changes in 250 subjects (20 locally) assigned to the two different nucleoside reverse transcriptase inhibitor (NRTI) combinations given in A5202.