A5202, FINAL VERSION 10, 05/05/05: INITIAL THERAPY WITH DIFFERENT ANTIRETROVIRA

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。 这是一项IIIB期随机、部分盲法研究，比较了四种ARV方案的有效性、安全性和耐受性： 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，每日1次，RTV 100 mg，每日1次，FTC 200 mg/TDF 300 mg，每日1次，ABC/3TC，安慰剂，每日1次 ARM D：ATV 300 mg qd+RTV 100 mg qd ABC 600 mg/3TC 300 mg qd FTC/TDF安慰剂qd 符合条件的受试者将是未服用抗逆转录病毒药物(在进入研究前任何时候接受抗逆转录病毒治疗的天数*)，并在进入研究前90天内获得血浆HIV-1RNA和1000拷贝/毫升。将不会有CD4T细胞计数的限制。 *唯一的例外是：(1)使用抗病毒药物作为暴露后预防(PEP)的一部分，前提是受试者在需要暴露后预防的事件中没有感染艾滋病毒-1。(2)使用非NRTI、NNRTI或PI的研究用ARV药物进行治疗。 1800名受试者(每个研究组450人)将在大约96周内登记。受试者将根据筛查时的HIV-1 RNA水平(100,000拷贝/毫升与100,000拷贝/毫升)以及参加新陈代谢亚研究A5224的意图和资格进行分层。在最后一名受试者被录取后，受试者将被跟踪大约96周。 这项研究已被授予IND豁免地位。

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. This is a phase IIIB, randomized, partially blinded study comparing the efficacy, safety, and tolerability of four ARV regimens: 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 Eligible subjects will be ARV drug-naive (< days of ARV treatment at any time prior to entry*) with plasma HIV-1 RNA >1000 copies/ml obtained within 90 days prior to study entry. There will be no CD4+ T-cell count restriction. *The only exceptions are: (1)Use of antivirals as part of post-exposure prophylaxis (PEP) provided the subject did not acquire HIV-1 infection fkom the event that required PEP. (2) Therapy with an investigational ARV drug that was not an NRTI, NNRTI, or PI. 1800 subjects (450 per study arm) will enroll over approximately 96 weeks. Subjects will be stratified by HIV-1 RNA level at screening (<100,000 copies/ml versus >100,000 copies/ml) and intent and eligibility to enroll in the metabolic substudy A5224s. Subjects will be followed for approximately 96 weeks after the last subject is enrolled. This study has been granted IND exempt status.