A5202

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。 设计A5202是一项IIIB期随机四臂研究，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。 持续时间：在最后一门课程注册后大约96周。 样本量：A5202将招募1800名受试者(每个治疗组450人)。 人群：HIV-1感染，抗逆转录病毒(ARV)药物，年龄16岁，血浆HIV-1RNA水平在研究进入前90天内获得1000拷贝/毫升。 进入受试者的治疗方案将随机分为以下几种： A组：EFV 600 mg qd+FTC 200 mg/TDF 300 mg qd+ABC/3TC安慰剂qd B组：EFV 600 mg qd+ABC 600 mg/3TC 300 mg qd+FTC/TDF安慰剂qd C组：ATV 300 mg qd+RTV 100 mg qd+FTC 200 mg/TDF 300 mg qd+ABC/3TC安慰剂qd ARM D：ATV 300 mg qd+RTV 100 mg qd+ABC 600 mg/3TC 300 mg qd+FTC/TDF安慰剂qd 三个主要目标是： 1.比较病毒学失败的方案之间的病毒学疗效，病毒学失败的定义是在16周或之后和24周之前确定血浆HIV-1 RNA水平E1000拷贝/毫升或在24周或之后确定E200拷贝/毫升的时间。 2.比较安全性定义为首次出现3级或4级体征、症状或实验室异常且至少比基线高一级的安全性的方案之间的安全性。 3.比较方案之间的耐受性和耐受性，耐受性定义为在初始治疗方案中改变一种或多种药物的时间

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. DESIGN 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. DURATION: Approximately 96 weeks beyond the enrollment of the last subject. SAMPLE SIZE: A5202 will enroll 1800 subjects (450 per treatment arm). POPULATION: HIV-1-infected, antiretroviral (ARV) drug-na¿ve men and women e16 years of age with plasma HIV-1 RNA levels 1000 copies/mL obtained within 90 days prior to study entry. REGIMEN At entry subjects will be randomized to one of the following: ARM A: EFV 600 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC placebo QD ARM B: EFV 600 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF placebo QD ARM C: ATV 300 mg QD with RTV 100 mg QD + FTC 200 mg/TDF 300 mg QD + ABC/3TC placebo QD ARM D: ATV 300 mg QD with RTV 100 mg QD + ABC 600 mg/3TC 300 mg QD + FTC/TDF placebo QD The three primary objectives are: 1. To compare virologic efficacy between regimens with virologic failure defined as the time to confirmed plasma HIV-1 RNA level e1000 copies/mL at or after 16 weeks and before 24 weeks or e200 copies/mL at or after week 24. 2. To compare the safety between regimens with safety defined as the time to first development of Grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline. 3. To compare the tolerability between regimens with tolerability defined as the time to change in one or more drugs in the initial treatment regimen