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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 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 研究中心，而研究中心不一定是研究者所在的机构。 A5202是一项IIIB期、随机、四组研究，比较了开放标签利托那韦（RTV）增强阿扎那韦（ATV）与依法韦仑（EFV）的疗效、安全性和耐受性，与每日恩曲他滨（FTC）/替诺福韦（TDF）或阿巴卡韦（ABC）/拉米夫定（3 TC）联合，以及部分盲法ABC/3 TC与FTC/TDF联合RTV-增强的ATV或EFV作为HIV-1感染的初始治疗。 受试者将在最后一例受试者入组后参加A5202约96周。预计累积需要96周，因此估计总研究持续时间约为192周。A5202将入组1800例受试者（每个治疗组450例）。HIV-1感染，抗逆转录病毒（ARV）药物初治（？在研究入组前的任何时间接受7天ARV治疗）男性和女性？16年来，？在研究入组前90天内获得的血浆HIV-1 RNA水平1000拷贝/mL的18耳（当地）。 受试者将在筛选时根据血浆HIV-1 RNA水平100，000和？100，000拷贝/mL，并且有意愿和资格入组代谢子研究A5224 s;接受恩曲他滨/替诺福韦或阿巴卡韦/拉米夫定联合依法韦仑或阿扎那韦联合利托那韦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-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.