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. PACTG 219C will address specific hypotheses in relation to the impact of perinatal HIV transmission interventions; primary HIV antiretroviral therapies; immune-based therapy/vaccines trials; and prophylaxis and treatment of the complications of HIV infection on long-term outcomes in HIV or ART exposed but uninfected, and HIV-infected pediatric patients. The long-term outcomes include benefits as well as adverse events from these interventions as reflected in survival, clinical disease progression, growth and development, immunologic function, virologic status, adverse drug reactions, and end-organ dysfunction. It is also anticipated that the longitudinal data and the repository specimens collected in this protocol will enable investigators in the PACTG to answer other research questions and future hypotheses specific to the pathophysiology of perinatal HIV infection.
The specific aims for protocol PACTG 219: pediatric late outcomes protocol is as follows: 1) To describe late outcomes over time in relation to survival, growth, neurologic and neuropsychologic function, quality of life, organ system toxicity, metabolic disorders, development of opportunistic infections and malignancies and immunologic and virologic parameters in HIV-infected infants, children, and adolescents. This will also include evaluation of potential late effects, impact of puberty and complications of antiretroviral and immune therapy received by the subjects; 2) To determine if uninfected infants born to women who meet any of the following criteria: a) Diagnosed as HIV-infected b) Received antiretroviral therapy during pregnancy c) Received immune therapy/HIV-vaccines during pregnancy, demonstrate any short or long term adverse clinical or laboratory effects due to viral or treatment exposure in utero, the perinatal period, or early infancy.; and 3) To describe the demographic and clinical characteristics of infants, children, and adolescents followed at PACTG sites in order to assist PACTG investigators in planning future clinical trials and to identify changes in the natural history of HIV infection in infants, children, and adolescents. Included are the offspring of HIV infected children who may suffer long-term consequences regardless of their HIV-infection status.
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