ACTG A5142

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 摘要：A5142 A5142是一项III期、随机化、三组、开放标签研究，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）增强蛋白酶抑制剂（PI）的方案与核苷类逆转录酶抑制剂（NRTI）保留方案的有效性。 受试者将在末例受试者入组后参加本研究96周。 本研究将入组660例HIV-1感染、抗逆转录病毒（ARV）初治（定义为接受任何ARV药物治疗< 7天）的男性和女性受试者，年龄13岁，血浆HIV-1 RNA水平 2000拷贝/mL。 受试者将在随机化时通过筛选血浆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B型肝炎表面抗原，或两者兼有）。 还将根据NRTI（ZDV或d4 T XR）的选择对随机化进行分层。 摘要：A5160 S A5142的这项病毒动力学子研究将评估A5142中三种治疗方案的相对抗逆转录病毒效力（通过A5142三个组之间的第一阶段病毒衰减率测量），将该效力与长期病毒学应答联系起来，并评估男性和女性开始抗逆转录病毒治疗后的病毒动力学是否不同。 66例受试者（A5142每组11例男性受试者和11例女性受试者）将入组该子研究，该研究将持续96周或直至受试者停止初始研究治疗

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