INITIAL THERAPY FOR HIV-I INFECTION (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。方案目标和主要假设：比较HIV感染的三个治疗组之间的病毒学失败时间：洛匹那韦/利托那韦加伊法韦仑，洛匹那韦/利托那韦加2硝基转移酶抑制剂，和法韦伦加2硝基转移酶抑制剂。比较三个治疗组之间完成方案的时间成对：洛比那韦/利托那韦加伊法韦仑，洛比那韦/利托那韦加2硝基转移酶，和法韦伦加2硝基转移酶。方案的完成将被定义为病毒学失败或与毒性相关的初始随机治疗方案的任何组成部分的终止。在这项研究中使用Lopinavir/ritonavir将允许直接比较基于PI和NNRTI的初始治疗的有效性和持久性。Lopinavir/ritonavir加efavirenz联合用药将同时对非NRTI保留方案的ARV活性和毒性进行重要的同时比较。重要的新陈代谢问题将被前瞻性地解决。这些方案的病毒学失败后观察到的耐药性模式将被描述。(ACTG A5142)

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. Protocol Objectives and Main Hypotheses: To compare the time to virologic failure pair wise between the three treatment groups for HIV Infection: Lopinavir/ritonavir plus efavirenz, lopinavir/ritonavir plus 2 NRTIs, and efavirenz plus 2 NRTIs. To compare the time to regimen completion pair wise between the three treatment groups: Lopinavir/ritonavir plus efavirenz, lopinavir/ritonavir plus 2 NRTIs, and efavirenz plus 2 NRTIs. Regimen completion will be defined as either virologic failure or toxicity-related discontinuation of any component of the initial randomized treatment regimen. The use of lopinavir/ritonavir in this study will allow a direct comparison of the efficacy and durability of PI-versus NNRTI-based initial therapy. The lopinavir/ritonavir plus efavirenz combination will provide an important, concurrent comparison of the ARV activity and toxicity of an NRTI-sparing regimen. Important metabolic issues will be addressed prospectively. The patterns of resistance observed following virologic failure with these regimens will be characterized. (ACTG A5142)