ACUTE HIV INFECTION AND EARLY DISEASE RESEARCH PROGRAM (AIEDRP)

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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 purpose of this protocol is to establish a cohort of of HIV-1 infected individuals who are participating in studies of HIV-1 pathogenesis, studies evaluating theraputic strategies in individual AIEDRP clinical trials amp; subjects who defer therapy who agree to be followed in this protocol. Enrolled subjects will be stratified in the database with regard to acute or recent HIV-1 infection. This will allow cross protocol analysis to address specific long term questions related to the pathogenesis and treatment of acute or recent HIV-1 infection. Enrolled subjects may contribute data to multiple analyses. The primary aim of this protocol is to determine the long term virologic, immunologic and clinical outcomes and complications for subjects who were diagnosed during acute or early infection and who either begin therapy immediately, or defer therapy until some future point in the course of chronic HIV-1 disease. The rationale for establishing the AIEDRP long term cohort is to continue to follow and collect important outcomes over time, even after subjects have completed a time-limited clinical trial or intervention, will be important in evaluating the long-term impact of interventions that take place in the setting of acute and/or recent HIV-1 infection. Subjects who enroll in the parent protocol for this project will also co-enroll in this protocol for data collection. This protocol requires data to be submitted for baseline visit, weeks, 2, 4, 12, and every 12 weeks thereafter until week 168 (3 years on study), subjects will then have visits every 24 weeks for the duration of the study. If additional visits are made at any time during the study, all relevant data for which CRFs exist will be submitted to the AIEDRP CORE01 Data Base. The overall objective of the CORE01 protocol is to provide a uniform definition and schedule of visits for individuals with acute and early HIV-1 infection to be entered into a clinical database. The AIEDRP CORE01 Database Protocol will establish a cohort of HIV-1-infected individuals who are participating in studies of HIV-1 pathogenesis, studies evaluating therapeutic strategies in individual site AIEDRP clinical trials, and of subjects who choose to defer therapy but agree to be followed in this protocol. Enrolled subjects will be stratified in the database with regard to acute or recent HIV-1 infection. The collection of prospective data in a defined manner will allow cross-protocol analyses to address specific long-term scientific questions related to the pathogenesis and treatment of acute or recent HIV-1 infection. Enrolled subjects may contribute data to multiple analyses. The primary aim of this protocol is to determine the long-term virologic, immunologic, and clinical outcomes and complications for subjects who were diagnosed during acute or early HIV-1 infection and who either began therapy immediately, or defer therapy until some future point in the course of chronic HIV-1 disease. Results from the pathogenesis and therapeutic intervention clinical trials currently or previously conducted within the AIEDRP have contributed and continue to contribute to our understanding of the pathogenesis of HIV-1 disease. However, new developments in HIV-1 pathogenesis, the availability of improved tools and mechanisms for monitoring HIV-1 replication in plasma and tissue reservoirs, and the development of novel antiretroviral therapies and treatment strategies will require ongoing assessment of these in subjects with acute or recent infection. The AIEDRP CORE01 Database Protocol will facilitate longitudinal and prospectively planned meta-analyses or cross-protocol analyses of the studies conducted at individual AIEDRP units, in which information about specific antiretroviral or therapeutic intervention regimens or strategies, the use of new tools for real-time monitoring of antiretroviral effects and development of drug resistance, and factors that impact on treatment response will be performed to address and compare longer term strategic approaches to management of individuals acutely or recently infected with HIV-1. This CORE01 Protocol will provide the framework for evaluating across individual sites and protocols the longer term strategic questions regarding comparisons of initial treatment regimens, determination of viral load or other thresholds for switching a drug or combinations of drugs, and the contribution of drug exposure to treatment outcome. Questions related to immune preservation and reconstitution and pathogen-specific immunity can also be addressed in the context of the interventional strategies and short-term pathogenesis studies that are being conducted and evaluated. The development of a prospective, longitudinal database including a variety of therapeutic interventions in the setting of acute or recent infection will also permit examination of demographic and host characteristics that are associated with various clinical outcomes.