INITIAL THERAPY FOR HIV-I INFECTION (ACTG A5142)

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来源获得了主要资金，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。方案目的和主要假设：成对比较三个治疗组（洛匹那韦/利托那韦+依法韦仑、洛匹那韦/利托那韦+2种NRTI和依法韦仑+2种NRTI）治疗HIV感染的至病毒学失败时间。 比较三个治疗组之间的至方案完成时间：洛匹那韦/利托那韦+依法韦仑、洛匹那韦/利托那韦+2种NRTI和依法韦仑+2种NRTI。方案完成将定义为病毒学失败或初始随机化治疗方案任何组分的毒性相关停药。 在本研究中使用洛匹那韦/利托那韦将允许直接比较PI与NNRTI为基础的初始治疗的疗效和持久性。洛匹那韦/利托那韦加依法韦仑联合用药将为NRTI保留方案的ARV活性和毒性提供重要的同步比较。将前瞻性地解决重要的代谢问题。将描述这些方案病毒学失败后观察到的耐药模式。(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)