ACTG A5142

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。A5142是一项III期、随机、三组、开放标签的研究，比较基于非核苷类逆转录酶抑制剂（NNRTI）的方案与基于利托那韦（RTV）增强的蛋白酶抑制剂（PI）方案与核苷类逆转录酶抑制剂（NRTI）节省方案的有效性。在最后一名受试者入组后，受试者将参与本次研究96周。本研究将招募660名HIV-1感染、未接受抗逆转录病毒（ARV）治疗（定义为接受任何抗逆转录病毒药物治疗< 7天）的男性和女性受试者，年龄13岁，血浆HIV-1 RNA水平为2000拷贝/mL。受试者将通过筛查血浆HIV-1 RNA（<100,000拷贝/mL vs 100,000拷贝/mL）和慢性肝炎感染（存在丙型肝炎抗体或乙型肝炎表面抗原，或两者均存在）进行随机分层。随机化也将通过选择NRTI （ZDV或d4T XR）进行分层。这项A5142病毒动力学亚研究将评估A5142中三种治疗方案的相对抗逆转录病毒效力（通过A5142三个治疗组之间的第一期病毒衰减率来测量），将这种效力与长期病毒学反应联系起来，并评估开始抗逆转录病毒治疗后的病毒动力学在男性和女性之间是否存在差异。66名受试者（A5142每组11名男性和11名女性）将被纳入本子研究，该子研究将持续96周或直到受试者停止其初始研究治疗

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