CLINICAL TRIAL: A PHASE III COMPARATIVE STUDY OF THREE NON-NUCLEOSIDE REVERSE TR

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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. The primary objective of this protocol is to compare the virologic efficacy and tolerability of combination regimens that include FTC/TDF plus RAL, ATV/r, or DRV/r for treatment of ARV-naive subjects. The secondary objectives include: 1.3.1 To compare the toxicity of combination regimens that include FTC/TDF plus RAL, ATV/r, or DRV/r for treatment of ARV-naive subjects. 1.3.2 To support the primary virologic endpoint in the context of treatment discontinuation and switches. 1.3.3 To compare the impact of the three treatment regimens on the evolution of drug resistance at the time of first failure and to correlate NRTI, INI, and PI genotypic resistance with kinetics of viral decay at 4 weeks after therapy initiation. 1.3.4 To compare CD4+ T-cell count responses to the three treatment regimens over time. 1.3.5 To assess the occurrence of targeted clinical events. 1.3.6 To evaluate the impact of the three treatment regimens on virologic and immunologic responses, toxicity, and tolerability by gender and race/ethnicity. 1.3.7 To examine the association of early changes and suppression in HIV-1 RNA level and long-term virologic efficacy. 1.3.8 To compare the impact of the study regimens on lipid levels, glucose, prevalence of metabolic syndrome, and Framingham scores for risk of myocardial infarction (MI). 1.3.9 To compare the effect of DRV on RTV plasma exposure to that of ATV, and to examine the relationship between RTV exposure and changes in triglycerides and non-high density lipoprotein (HDL) cholesterol in the DRV/r and ATV/r arms. 1.3.10 To examine the impact of treatment and changes in HIV-1 RNA level on perception of infectiousness, and that perception¿s impact on transmission-associated behavior over time. 1.3.11 To assess adherence to the ARV regimens using self-report questionnaires and compare differences by race/ethnicity, gender, and self-reported behaviors and to evaluate the relationship between adherence and metabolic, immunologic, and virologic outcomes, and development of HIV-resistance.