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. ABSTRACT: A5142 A5142 is a phase III, randomized, three-arm, open-label study comparing the effectiveness of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen vs a ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen vs a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen. Subjects will participate in this study for 96 weeks beyond the enrollment of the last subject. This study will enroll 660 HIV-1-infected, antiretroviral (ARV)-naive (defined as < 7 days of therapy with any ARV drug) male and female subjects, 13 years of age with plasma HIV-1 RNA levels 2000 copies/mL. Subjects will be stratified at randomization by screening plasma HIV-1 RNA (<100,000 copies/mL versus 100,000 copies/mL) and chronic hepatitis infection (presence of either hepatitis C antibody or hepatitis B surface antigen, or both). Randomization will also be stratified by selection of NRTI (either ZDV or d4T XR). ABSTRACT: A5160S This viral dynamics substudy of A5142 will assess the relative antiretroviral potency of the three treatment regimens in A5142 as measured by the first-phase viral decay rate between the three arms of A5142, relate this potency to longer term virologic response, and assess whether the viral dynamics after initiation of antiretroviral therapy are different between men and women. 66 subjects - eleven male subjects and eleven female subjects from each arm of A5142 - will be enrolled into this substudy, which will continue for 96 weeks or until subjects discontinue their initial study treatment
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