A PHASE IIIB, RANDOMIZED, TRIAL OF OPEN-LABEL EFAVIRENZ OR ATAZANAVIR WITH RI

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iii期、随机、四组研究，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，以及部分盲法ABC/3TC与FTC/TDF联合RTV增强ATV或EFV作为HIV-1感染的初始治疗。受试者将在最后一个受试者入组后参加A5202约96周。预计应计期为96周，因此估计总研究时间约为192周。A5202将招募1800名受试者（每个治疗组450名）。hiv -1感染，抗逆转录病毒（ARV）药物(？在研究开始前的任何时间接受7天抗逆转录病毒治疗)男性和女性？16年[?]18耳（当地）年龄，在研究开始前90天内获得血浆HIV-1 RNA水平为1000拷贝/mL。受试者将根据血浆HIV-1 RNA水平<100,000和？100,000拷贝/mL，加入代谢亚研究A5224s的意向和资格；接受恩曲他滨/替诺福韦或阿巴卡韦/拉米夫定与依非韦伦或阿扎那韦联合Ri治疗的受试者的长期代谢评估

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, randomized, four-arm study, comparing 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 of partially blinded ABC/3TC compared to FTC/TDF in combination with either RTV-enhanced ATV or EFV as initial therapy for HIV-1 infection. Subjects will participate in A5202 for approximately 96 weeks beyond the enrollment of the last subject. Accrual is anticipated to take 96 weeks, resulting in an estimated total study duration of approximately 192 weeks. A5202 will enroll 1800 subjects (450 per treatment arm). HIV-1-infected, antiretroviral (ARV) drug-nanve (?7 days of ARV treatment at any time prior to study entry) men and women ?16 years [? 18 ears locally] of age with plasma HIV-1 RNA levels >1000 copies/mL obtained within 90 days prior to study entry. Subjects will be stratified at screening based on plasma HIV-1 RNA levels <100,000 and ?100,000 copies/mL and intent and eligibility to enroll in the metabolic substudy A5224s; Long-Term Metabolic Assessments in Subjects Treated with Emtricitabine/Tenofovir or Abacavir/Lamivudine with either Efavirenz or Atazanavir with Ri