ADULT AIDS CLINICAL TRIAL GROUP LONGITUDINAL LINKED RANDOMIZED TRIALS PROTOCOL

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。 ALLRT方案是一系列计划中的前瞻性荟萃分析和交叉方案分析，将从一个既定的纵向和横向队列中收集数据，这些人群中的艾滋病毒感染者已被前瞻性随机纳入批准的母公司AACTG临床试验，并同意接受长期跟踪，目的是评估与有效的抗逆转录病毒疗法长期治疗相关的临床、病毒学、免疫学和药理学结果。最初进入ALLRT方案的所有受试者将同时参加父母AACTG研究或在过去8周内完成父母临床试验。进入ALLRT方案的受试者可能会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。长期随访将继续在双亲AACTG方案的范围内进行，直到这些研究结束或达到终点。对于进入ALLRT方案的受试者，如果他们到达其父方案或其父方案的终点，否则参与替代AACTG随机试验的时间不能立即获得或不可行，则将根据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，受试者可以登记参加更多的随机AACTG临床试验，并仍然参与ALLRT方案，HIV感染的抗逆转录病毒治疗的初始受试者，以及以前或当前接受治疗的受试者，他们进入了母公司的AACTG临床试验，并同意接受临床、病毒学、免疫学和药理学终点的长期跟踪。 治疗方案是根据参与母公司AACTG临床试验的随机选项确定的。如果受试者完成或终止了母公司的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，治疗应该独立于A5001/ALLRT方案安排。ALLRT方案不提供任何治疗。

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.