COMPARISON OF INITIAL ANTRETROVIRAL REGIMENS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。A5202是一项针对HIV感染的初始治疗的IIIB期、多中心、随机、四组研究。该研究将比较开放标签利托那韦（RTV）增强阿扎那韦（ATV）与依非韦伦（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[3TC]）的疗效、安全性和耐受性，并比较部分盲法FTC/TDF与ABC/3TC（联合RTV增强ATV或EFV）。将招募1800名未接受治疗的受试者，并在最后一名受试者入组后随访96周；将以标准化的方式评估它们的有效性、安全性和耐受性。有3个可选的子研究，包括代谢子研究（A5224s），该研究需要使用GCRC进行双能x射线吸收仪（DEXA）扫描。代谢亚研究将评估250名受试者（20名局部）的代谢变化，这些受试者被分配给A5202中给予的两种不同的核苷逆转录酶抑制剂（NRTI）组合。

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.