ACTG A5142, V 20

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。A5142是第三阶段，随机，三臂，1.以非核苷逆转录酶抑制物(NNRTI)为基础的方案(efavirenz[EFV]+司他夫定缓释[d4T XR]或替诺福韦[TDF]+拉米夫定[3TC]的齐多夫定[ZDV})为基础的方案(Lopinavir/ritonavir[LPV/RTV]加dT XR[或ZDV或TDF+3TC])2.基于Lopinavir/ritonavir[LPV/RTV]的方案(Lopinavir/ritonavir[LPV/RTV])3.核苷逆转录酶抑制物(NRTI)-sping方案(EV+LPV/RTV))主要目标是成对比较三个治疗组之间的病毒学失败时间，并比较三个治疗组完成方案的时间。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。次要目标包括比较三个治疗组之间外周脂肪萎缩(脂肪损耗)的发生情况(通过肢体DEXA测量)，以及比较治疗组之间的下列代谢异常：高乳酸血症、躯干脂肪堆积、高胆固醇血症、高甘油三酯血症、胰岛素抵抗和骨质丢失。

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. A5142 is a phase III, randomized, three-arm, open-label study comparing the effectiveness of the following regimens for the initial treatment of HIV infection: 1. Nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen (efavirenz [EFV] plus Stavudine extended release [d4T XR] or zidovudine [ZDV} of Tenofovir disoproxil fumarate [TDF] plus lamivudine [3TC]) 2. Ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen (lopinavir/ritonavir [LPV/RTV] plus d4T XR [or ZDV or TDF] plus 3TC) 3. Nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen (EFV plus LPV/RTV) The primary objectives are to compare the time to virologic failure pairwise between the three treatment groups, and to compare the time to regimen completion between the three treatment groups. Regimen completion will be defined as either virologic failure or toxicity-related discontinuation of any component of the initial randomized treatment regimen. Secondary objectives include comparing between the three treatment arms the occurrence of peripheral lipoatrophy (fat wasting) as measure by limb DEXA, and to compare between the treatment groups the following metabolic abnormalities: hyperlactatemia, truncal fat accumulation, hypercholesterolemia, hypertriglyceridemia, insulin resistance, and bone loss.