ACTG 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。 目前的艾滋病毒-1感染初始治疗指南为患者和提供者提供了许多选择(可在http://www.aidsinfo.nih.gov/).获得已经有越来越多的被批准的抗逆转录病毒药物和研究表明，当采用有效、耐受性良好和简单的方案时，病毒学上的成功水平很高。在卫生与公众服务部(DHHS)首选的方案中，两种核苷逆转录酶抑制剂(NRTI)与NNRTI EFV是最容易服用的组合，并且在迄今进行的随机对照试验中总体成功率最高[1-3]。然而，最近批准的新型药物提供了简单的每日一次的蛋白酶抑制剂(PI)以及具有较长半衰期的每日一次的NRTI组合，这可能比现有的治疗方法提供独特的优势。随着新制剂的出现，评估它们在优化艾滋病毒-1管理方面的作用至关重要。这包括了解相对效力、耐受性、出现的耐药模式，以及如果新方案出现耐药性时的后续治疗选择。这项研究将比较RTV增强型ATV与EFV联合每日FTC/TDF或ABC/3TC的使用，以及ABC/3TC与FTC/TDF联合EFV或RTV增强型ATV作为HIV-1感染的初始治疗的比较。 假设 RTV增强型ATV联合FTC/TDF的抗病毒效果与EFV联合FTC/TDF相当。 RTV增强型ATV联合ABC/3TC的抗病毒效果与EFV联合ABC/3TC相当。 EFV与ABC/3TC联用与EFV与FTC/TDF联用的抗病毒效力相当。 RTV增强型ATV联合ABC/3TC的抗病毒效果与RTV增强型ATV联合FTC/TDF相当。 主要目标遵循比较研究PI(RTV增强ATV)和研究NNRTI(EFV)的每个NRTI组合的模式；当与研究PI或研究NNRTI一起使用时，NRTI组合彼此之间。这四个比较是针对三个主要目标(有效性、安全性和耐受性)进行的。 比较病毒学失败的方案之间的病毒学疗效，定义为在16周或之后、24周前或24周前确认血浆HIV-1 RNA水平=1000拷贝/毫升或在24周或之后=200拷贝/毫升的时间。 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。 比较不同治疗方案之间的耐受性，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. Current guidelines for the initial treatment of HIV-1 infection provide a number of options for patients and providers (available at http://www.aidsinfo.nih.gov/). There have been an ever-growing number of approved ARV agents and studies that demonstrate high levels of virologic success when employing potent, well-tolerated, and simple regimens. Of the Department of Health and Human Services (DHHS) preferred regimens, two nucleoside reverse transcriptase inhibitors (NRTIs) with the NNRTI EFV is the simplest combination to take and has had the highest overall success rates in randomized controlled trials done to date [1-3]. However, novel agents have recently been approved that provide simple once daily protease inhibitors (PIs) as well as once daily NRTI combinations with prolonged half-lives that may offer unique advantages over established therapies. As novel agents become available it is critical to assess their role in optimizing the management of HIV-1. This includes understanding the relative potency, tolerability, resistance patterns that emerge, and the consequent remaining treatment options if drug resistance occurs for newer regimens. This study will compare the use of RTV-enhanced ATV to EFV, in combination with either daily FTC/TDF or ABC/3TC, and of ABC/3TC compared to FTC/TDF in combination with either EFV or RTV-enhanced ATV as initial therapy for HIV-1 infection. Hypotheses RTV-enhanced ATV in combination with FTC/TDF is equivalent to EFV in combination with FTC/TDF with respect to antiviral potency. RTV-enhanced ATV in combination with ABC/3TC is equivalent to EFV in combination with ABC/3TC with respect to antiviral potency. EFV in combination with ABC/3TC is equivalent to EFV in combination with FTC/TDF with respect to antiviral potency. RTV-enhanced ATV in combination with ABC/3TC is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to antiviral potency. The primary objectives follow a pattern of comparing the study PI (RTV-enhanced ATV) with the study NNRTI (EFV) for each of the NRTI combinations; and the NRTI combinations with each other, when used with the study PI or the study NNRTI. These four comparisons are made for each of the three main objectives (efficacy, safety, and tolerability). To compare virologic efficacy between regimens with virologic failure defined as the time to confirmed plasma HIV-1 RNA level =1000 copies/mL at or after 16 weeks and before 24 weeks or =200 copies/mL at or after week 24. 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. To compare the tolerability between regimens with tolerability defined as the time to change in one or more drugs in the initial treatment regimen.