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.The purpose of this study is to estimate the occurrence of potential antiretroviral therapy (ART)-related toxicities through an ongoing surveillance system among HIV-uninfected children born to mothers with HIV infection with and without exposure to ART in utero and/or in the first two months of life and compare the occurrences of these outcomes with other sources of data as well as by ART exposures. It is a prospective cohort study designed to estimate the incidence of conditions and diagnoses potentially related to in utero exposure to ART and/or exposure in the first two months of life among children born of HIV-infected mothers (source population). Children who were exposed to ART in utero and/or in the first two months of life as well as children who have never been exposed to ART will be enrolled and followed. The study will use a registry approach to conduct active surveillance among children <12 years of age at enrollment. The study will follow two cohorts of HIV-exposed children. One, the Static Surveillance Cohort, will include children previously enrolled in longitudinal natural history cohorts, principally WITS and PACTG 219C. The second cohort, the Dynamic Surveillance Cohort, will include children who are enrolled from prior to birth through <72 hours of age and will be followed using a similar protocol. The experience of both surveillance cohorts will be compared to existing data from other cohort studies or national data. It will be necessary to enroll a limited cohort of HIV-unexposed, -uninfected children to serve as a reference group for the neurodevelopmental studies because of the high rate of abnormalities expected in the target populations compared to national norms. This will be done in Year 2 of clinical data collection under a separate protocol. There will be annual visits with medical, neurologic, neurodevelopmental, behavioral, language, growth, metabolic, cardiac, hearing, and laboratory studies including mitochondrial studies.
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