COMPARISON OF INITIAL ANTRETROVIRAL REGIMENS

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。所列机构为中心机构，不一定为研究者机构。A5202是一项IIIB期、多中心、随机、四组HIV感染初始治疗研究。它将比较开放标签利托那韦（RTV）增强阿扎那韦（ATV）与依法韦仑（EFV）（联合每日恩曲他滨[FTC]/替诺福韦[TDF]或阿巴卡韦[ABC]/拉米夫定[3 TC]）的疗效、安全性和耐受性;并比较部分盲法FTC/TDF与ABC/3 TC（联合RTV增强ATV或EFV）。将入组1800例未经治疗的受试者，并在最后一例受试者入组后随访96周;将以标准化方式评价其疗效、安全性和耐受性。有3个可选子研究，包括代谢子研究（A5224 s），需要使用GCRC进行双能X线吸收测定（DEXA）扫描。代谢子研究将评价分配至A5202中两种不同核苷逆转录酶抑制剂（NRTI）联合治疗的250例受试者（20例当地受试者）的代谢变化。

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. A5202 is a phase IIIB, multicenter, randomized, four-arm study of initial therapy for HIV infection. It will compare the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced atazanavir (ATV) to efavirenz (EFV) (in combination with either daily emtricitabine [FTC]/tenofovir [TDF] or abacavir [ABC]/lamivudine [3TC]; and compare partially blinded FTC/TDF to ABC/3TC (in combination with either RTV-enhanced ATV or EFV). 1800 treatment-nanve subjects will be enrolled and followed for 96 weeks after the last subject enrolls; they will be evaluated in a standardized fashion for efficacy, safety, and tolerability. There are 3 optional substudies, including a metabolic substudy (A5224s) that requires use of the GCRC for dual-energy x-ray absorptiometry (DEXA) scans. The metabolic substudy will evaluate the metabolic changes in 250 subjects (20 locally) assigned to the two different nucleoside reverse transcriptase inhibitor (NRTI) combinations given in A5202.