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

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。对新治疗策略和药物的作用及其在管理HIV-1感染中的作用进行关键评估是至关重要的。ACTG A5142是一项III期、随机、三组、开放标签研究，比较基于nnrti的方案（依非韦伦+司他夫定缓释或齐多夫定+拉米夫定）、利托那韦增强的基于pi的方案（洛匹那韦/利托那韦+司他夫定缓释或齐多夫定+拉米夫定）和保留nrti的方案（依非韦伦+洛匹那韦/利托那韦）初始治疗HIV感染的有效性。这项研究将着眼于洛匹那韦/利托那韦的作用，一种利托那韦增强的第二代PI，以及一种nrti保留方案，这些在目前的研究中没有得到充分的解决。该研究将招募660名病毒载量等于或大于2000拷贝/mL的HIV-1、抗逆转录病毒男性和女性受试者。这是一个96周的研究；受试者将继续研究，直到最后一名受试者完成96周。学习有三个步骤。第一步是在研究开始时随机分配初始研究方案。在步骤1中对单一药物有毒性的受试者替代了单一类别内的药物，将注册到步骤2。步骤1或2中出现病毒学失败或治疗限制性毒性的受试者将登记到步骤3。

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.