ACTG A5142: A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON OF LOPINAVIR/

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。所列机构为中心，不一定是研究者所在机构。必须严格评估新的防治战略和药物的作用及其在管理HIV-1感染方面的作用。ACTG A5142是一项III期、随机、三组、开放标签研究，比较了基于NNRTI的方案（依法韦仑+司他夫定缓释剂或齐多夫定+拉米夫定）、利托那韦增强PI方案（洛匹那韦/利托那韦+司他夫定缓释剂或齐多夫定+拉米夫定）和NRTI保留方案（依法韦仑+洛匹那韦/利托那韦）用于HIV感染初始治疗的有效性。 本研究将探讨洛匹那韦/利托那韦（利托那韦增强的第二代PI）和NRTI保留方案的作用，这些在当前研究中未得到充分解决。 本研究将入组660例病毒载量≥ 2000拷贝/mL的HIV-1抗逆转录病毒男性和女性受试者。这是一项为期96周的研究;受试者将继续参与研究，直至最后一例入组受试者完成96周。 这项研究有三个步骤。步骤1是在研究入组时随机分配至初始研究方案。在第1步中对单一药物有毒性的受试者，如果用单一类内药物替代，将登记进入第2步。第1步或第2步中发生病毒学失败或治疗限制性毒性的受试者将登记进入第3步。

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. Critical assessment of the role of newer treatement strategies and drugs as they become available and their role in management of HIV-1 infection is essential. ACTG A5142 is a phase III, randomized, three-arm, open label study comparing the effectiveness of an NNRTI-based regimen (efavirenz + stavudine extended release or zidovudine + lamivudine), a ritonavir-enhanced PI-based regimen (lopinavir/ritonavir + stavudine extended release or zidovudine + lamivudine) and an NRTI-sparing regimen (efavirenz + lopinavir/ritonavir) for the initial treatment of HIV infection. This study will look at the role of lopinavir/ritonavir, a ritonavir-enhanced second generation PI, and an NRTI-sparing regimen, which are not being addressed adequately in current research. The study will enroll 660 HIV-1, antiretroviral male and female subjects having a viral load equal to or greater than 2000 copies/mL. This is a 96-week study; subjects will continue on study until the last subject enrolled completes 96 weeks. There are three steps to the study. Step 1 is randomization to initial study regimens at study entry. Subjects with a toxicity to a single drug on Step 1 who substitute a single, within-class drug will register to Step 2. Subjects on Step 1 or 2 who develop virologic failure or a treatment-limiting toxicity will register to Step 3.