This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.1. Research Questions to be addressed by this protocolThe AIEDRP Protocol was developed in 1996 as we began to understand the importance of the early natural history of HIV infection. Our interest was to develop a cohort of patients in whom we could study the natural history of HIV infection and response to therapy. Our interests included:1. establishment of viral set point2. mechanisms of host response 3. impact of potent antiretroviral therapy on disease progressionFrom inception until May, 2002, when the protocol was scheduled for phase-out by NIAID and new enrollment was no longer permitted, ninety-two participants with acute or early HIV infection were enrolled. The research plan outlined below describes the manner in which all current participants will be followed.2. Rationale for researchMotivation for researchThe Acute HIV Infection and Early Disease Research Program (AIEDRP) of the National Institute of Allergy and Infectious Diseases (NIAID) was established to develop, implement and evaluate data derived from innovative studies of pathogenesis and treatment interventions for subjects acutely or recently infected with HIV-1. Investigators participating in the AIEDRP use interventions, such as potent combination antiretroviral therapies, immunomodulators, structured treatment interruptions (STI), therapeutic immunization, or other novel approaches. Therapies are initiated or administered in the acute and early phases of HIV-1 infection.
Aims are to evaluate the immunologic and virologic mechanisms by which HIV-1 causes disease, the pathogenesis of immune dysregulation caused by or associated with acute HIV-1 infection, and the course of HIV-1 disease following immediate or delayed antiviral treatment in the setting of acute or recent infection. Investigations conducted by the AIEDRP also include individuals who elect not to receive antiretroviral therapy during acute or recent infection, and these individuals, in some instances, serve as untreated controls for the open-label pathogenesis and treatment studies described above. A further major goal of the AIEDRP is to evaluate the long-term clinical, virologic and immunologic outcomes of individuals in whom the interventions listed above are tested. The research units supported by the AIEDRP have incorporated both basic and translational laboratory as well as clinical components in their research studies. This will allow them to build upon recent advances to better understand HIV/AIDS pathogenesis, new potent and novel antiretroviral therapies, more effective tools for measuring and monitoring replication of HIV-1 in blood and tissue reservoirs, and the impact of viral replication in these reservoirs on immunologic function and viral evolution, including the development of drug resistance.
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