ADULT AIDS CLINICAL TRIAL GROUP LONGITUDINAL LINKED RANDOMIZED TRIALS PROTOCOL

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。ALLRT方案是一个计划中的一系列前瞻性荟萃分析和交叉方案分析，这些数据收集自一个已建立的纵向和横断面队列的hiv感染者，这些感染者已被前瞻性地随机分配到已批准的母体AACTG临床试验中，并同意长期随访，目的是评估与长效抗逆转录病毒治疗相关的临床、病毒学、免疫学和药理学结果。所有最初进入ALLRT方案的受试者将同时参与父级AACTG研究或在过去8周内完成父级临床试验的参与。进入ALLRT方案的受试者可能需要收集额外的血液和数据，用于临床、病毒学、免疫学和药理学评估。长期随访将在母体AACTG方案的范围内继续进行，直到这些研究结束或达到终点。对于进入ALLRT方案的受试者，如果达到其父方案的终点或其父方案的参与以其他方式结束，并且对于参加替代AACTG随机试验不能立即获得或可行的受试者，将根据ALLRT方案中概述的时间表继续进行临床、病毒学、免疫学和药理学监测的长期随访。随着时间的推移，受试者可能随后参加其他随机AACTG临床试验，并仍保持参与ALLRT方案、hiv感染、抗逆转录病毒治疗初治受试者以及先前或目前接受治疗的受试者，这些受试者进入母体AACTG临床试验，并同意长期随访临床、病毒学、免疫学和药理学终点。治疗方案是根据参与母体AACTG临床试验的随机选择来确定的。如果受试者完成或终止父母AACTG临床试验，并且没有立即加入另一个AACTG方案，如果继续治疗，则应独立于A5001/ALLRT方案安排。ALLRT协议不提供任何治疗。

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. The ALLRT protocol is a planned series of prospective meta-analyses and cross protocol analyses of data to be collected from an established longitudinal and cross-sectional cohortof HIV-infected individuals who have been prospectively randomized into approved parent AACTG clinical trials, and who have agreed to be followed long-term for the purpose of evaluating clinical, virologic, immunologic, and pharmacologic outcomes associated with long-term treatment with potent antiretroviral therapies. All subjects initially entered into the ALLRT protocol will be participating concurrently in a parent AACTG study or have completed participation in a parent clinical trial within the previous 8 weeks. Subjects entered into the ALLRT protocol may have additional blood and data collected for clinical, virologic, immunologic, and pharmacologic evaluations. Long-term follow-up will continue within the context of parent AACTG protocols until those studies close or an endpoint is reached. For subjects entered into the ALLRT protocol who reach an endpoint on their parent protocol or their parent protocol participation otherwise ends, and for whom participation in an alternative AACTG randomized trial is not immediately available or feasible, long-term follow-up with clinical, virologic, immunologic, and pharmacologic monitoring will continue according to the schedule outlined in the ALLRT protocol. Subjects may subsequently enroll in additional randomized AACTG clinical trials over time and still maintain participation in the ALLRT protocol, HIV-infected, antiretroviral treatment naive subjects and previously or currently treated subjects who are entered into parent AACTG clinical trials and who agree to be followed long-term for clinical, virologic, immunologic, and pharmacologic endpoints. Treatment regimens are determined according to randomized options available through participation in parent AACTG clinical trials. If a subject completes or terminates a parent AACTG clinical trial and does not immediately join another AACTG protocol, therapy, if continued, should be arranged independently of the A5001/ALLRT protocol. No treatment is provided through the ALLRT protocol.