ACTG A5142

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。摘要：A5142 A5142是一项III期随机三臂开放研究，比较了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)增强型蛋白酶抑制剂(PI)的方案与非核苷类逆转录酶抑制剂(NRTI)保留方案的有效性。受试者将在最后一名受试者注册后的96周内参加这项研究。这项研究将招募660名HIV-1感染、抗逆转录病毒(ARV)初治(定义为用任何ARV药物治疗7天)的男性和女性受试者，年龄13岁，血浆HIV-1RNA水平为2000拷贝/毫升。受试者将通过筛查血浆HIV-1RNA(100,000拷贝/毫升对100,000拷贝/毫升)和慢性肝炎感染(存在丙型肝炎抗体或乙肝表面抗原，或两者兼有)进行随机分层。随机分组还将通过选择NRTI(ZDV或d4T XR)进行分层。摘要：A5160这项针对A5142的病毒动力学亚研究将通过A5142三个臂之间的第一阶段病毒衰减率来评估A5142三种治疗方案的相对抗逆转录病毒效力，将这种效力与长期病毒学应答相关联，并评估开始抗逆转录病毒治疗后的病毒动力学是否存在性别差异。66名受试者--来自A5142每支手臂的11名男性受试者和11名女性受试者--将参加这项子研究，该研究将持续96周或直到受试者停止他们最初的研究治疗

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