"CNS HIV ANTI-RETROVIRAL THERAPY EFFECTS OF RESEARCH" (CHARTER)

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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 overarching aim of CHARTER is to employ validated reliable assessment methodologies to ascertain the prevalence and characteristics of neurobiological and neurobehavioral complications of HIV infection in the context of modern anti-retroviral (ARV) treatment approaches. These include the use of combination ARV ("highly actively antiretroviral treatment" or "HAART"), as well as the emerging treatment methodologies such as programmed interruption of treatment, the use of immunotherapies, and the possible availability of specific neuroprotective agents. In addition, selected groups "of interest" will be followed longitudinaly in order to gain insights into neurobiological and neurobehavioral outcomes as a function of virologic and immunologic response to treatment, the availability of drugs to penetate into the central nervous system (CNS), and past and present experience with various antiretroviral regimens. To continue to advance our understanding into mechanisms and early detection of neuropathogenesis, as well as to develop information that may inform future research into these questions, CHARTER proposes to examine longitudinally subgroups of subjects with specific methodologies that can shed light on metabolic/lipid disturbances in selected cases (and the CNS/PNS impacts of these), structural and functional brain imaging, viral genomics studies, and studies of population pharmacokinetics. To accomplish these goals and to address the scientific aims enumerated in the CHARTER protocol, our site will be prepared to commence accrual of an anticipated 67 HIV+ individuals annually per site per year for four years into the Cross-Sectional Study (total for entire 6 site study n=1,600). Each year, each site will select approximately 25 cases for long-term follow-up in the Longitudinal Pathogenesis Study (total for 6 site study n=600). These cases will be selected on the basis of there being a specific need for longitudinal data to answer certain critical questions about HIV CNS disease in the era of HAART as described in the CHARTER protocol.