ACTG A5001 - LONGITUDINAL LINKED RANDOMIZED TRIALS (ALLRT) PROTOCOL

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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 cohort of HIV-infected individuals who have been prospectively randomized into approved parent ACTG 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 ACTG 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 ACTG 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 ACTG 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 ACTG clinical trials over time and still maintain participation in the ALLRT protocol, with study visits timed to coincide as nearly as possible.