ACTG A5001 - AIDS LONGITUDINAL LINKED RANDOMIZED TRIALS

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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 will establish a prospective, longitudinal linked randomized trial cohort consisting of subjects randomly assigned to selected antiretroviral therapies, immune-based therapies, or strategies for management of anti-HIV interventions in AACTG or PACTG clinical trials. Enrolled subjects can be stratified in the database in a manner that will allow cross-protocol analyses to address specific long-term scientific questions. Enrolled subjects may contribute data to multiple analyses. Parent clinical trials from which initial subjects will be co-enrolled in the ALLRT protocol will be those that incorporate the following elements: 1) the provision of randomized, antiretroviral treatment, immune-based therapies, or strategies for the management of anti-HIV interventions; 2) collection of well-defined virologic, immunologic, and clinical data at the time of each randomization, treatment switch, or other defined interval for enrolled subjects; 3) the prospective establishment of rollover options for subjects who reach endpoints, e.g., who fail treatment or who develop a treatment-limiting intolerance to the initial agents in a protocol arm, or a plan to follow subjects for whom roll-over options are not available; and 4) a design for which long-term scientific objectives are appropriate to address. Specific hypotheses tested and scientific questions addressed by individual parent studies (e.g., how does regimen A compare to regimen B in subjects previously treated with regimen C) will be preserved in the parent studies, but data and findings from these parent studies will be examined in broader cross-protocol analyses within the ALLRT protocol, allowing long-term questions to be asked across multiple, randomized studies.