The objective of this proposal is to establish a Pediatric Component of the Adult ACTU in Western N.Y. Through State funding as a N.Y.S. Department of Health AIDS Institute, AIDS Designated Center in Rochester and as a SUNY Health Science Center in Syracuse, Pediatric Clinics have been established to provide care to HIV-infected children and infants exposed at birth as parts of comprehensive HIV programs. The Pediatric HIV Clinics are physically distinct from, but closely integrated with, Adult and Maternal HIV programs. The Pediatric Component of the Adult ACTU will be completely integrated with existing Pediatric HIV Clinics using the same staff to provide protocol and non-protocol care. Participation in ACTG protocols will afford otherwise unattainable therapeutic interventions to HIV- infected children in Western N.Y. while contributing Phase I-III data to the NIAID that will help in the development and selection of therapeutic agents for subsequent FDA approval. The Pediatric Component of the Adult ACTU will evaluate the safety and efficacy of therapeutic interventions for infants, children and adolescents with asymptomatic HIV infection, symptomatic HIV infection and conditions and opportunistic infections associated with HIV infection. Well established interactions between the Maternal and Pediatric Components will facilitate enrollment of HIV-infected women into therapeutic protocols that will require follow-up and/or therapy of the infants. Investigators will be involved in protocol development, patient enrollment and follow-up, data analysis and the presentation and publication of results.
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