A PHASE III B, RANDOMIZED, TRIAL OF OPEN-LABEL EFAVIRENZ OR ATAZANAVIR WITH RITO

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 A5202是一项IIIB期随机四臂研究，旨在比较开放标签利托那韦(RTV)增强型阿扎那韦(ATV)与依法韦仑(EFV)联合每日服用恩曲他滨(FTC)/替诺福韦(TDF)或阿巴卡韦(ABC)/拉米夫定(3TC)以及部分盲用ABC/3TC与FTC/TDF联合使用作为HIV-1感染的初始治疗的有效性、安全性和耐受性。在最后一门课程注册后，受试者将在约96周内参加A5202考试。预计应计期为96周，因此估计总研究持续时间约为192周。A5202将招收1800名受试者(每支治疗臂450名)。HIV-1感染的抗逆转录病毒(ARV)药物-NA(在进入研究前的任何时候接受ARV治疗7天)年龄16岁[当地18耳]的男性和女性，在进入研究前90天内获得血浆HIV-1RNA水平1000拷贝/毫升。受试者将根据血浆HIV-1RNA水平100,000和100,000拷贝/毫升以及参加代谢性亚研究A5224的意向和资格进行分层筛选；接受恩曲他滨/替诺福韦或阿巴卡韦/拉米夫定与依法维仑或阿扎那韦与利托那韦联合治疗的受试者进行长期代谢评估。

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-na¿ve (?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 Ritonavir.