ACTG A5142, V 20

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。所列机构为中心机构，不一定为研究者机构。A5142是一项III期、随机、三组、开放标签研究，比较以下方案用于HIV感染初始治疗的有效性：1.基于非核苷类逆转录酶抑制剂（NNRTI）的方案（依非韦伦[EFV]加司他夫定缓释剂[d4 T XR]或富马酸替诺福韦酯[TDF]加拉米夫定[3 TC]的齐多夫定[ZDV]）2.利托那韦（RTV）-增强的蛋白酶抑制剂（PI）为基础的方案（洛匹那韦/利托那韦[LPV/RTV]加d4 T XR [或ZDV或TDF]加3 TC）3.核苷逆转录酶抑制剂（NRTI）保留方案（EFV + LPV/RTV）主要目的是比较三个治疗组之间至病毒学失败的时间，并比较三个治疗组之间至方案完成的时间。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。 次要目的包括比较三个治疗组之间通过肢体DEXA测量的外周脂肪萎缩（脂肪消耗）的发生率，并比较治疗组之间的以下代谢异常：高乳酸血症、躯干脂肪蓄积、高胆固醇血症、高胆固醇血症、胰岛素抵抗和骨丢失。

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.