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 cohort of HIV-infected subjects. These subjects have been prospectively randomized into approved parent AACTG or PACTG clinical trials and 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. The primary objective is to determine therapeutic strategies or regimens that are effective in achieving long-term (durable) suppression of HIV-1 replication to levels below the limit of detection with the least associated toxicity. The strategies and regimens will be determined by the future antiretroviral studies in which subjects co-enroll. Data will be collected on various outcomes of initial HIV therapy, sustaining HIV therapy, and salvage therapy for those subjects for whom initial therapies fail due to virologic rebound. Data will also be collected and compared for opportunistic infections and other complications of HIV disease, as well as adverse effects, toxicities and complications associated with the various antiretroviral regimens used by the subjects enrolled in this study. Data collected will also be used to determine the factors associated with the degree of immunologic restoration during antiretroviral therapy.
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