In this renewal application, the Pediatric AIDS Clinical Trials Group Unit at the University of Miami School of Medicine, composed of a functionally integrated Perinatal/Pediatric Research Network of investigators from the Division of Pediatric Infectious Disease, Adolescent Medicine and Obstetrics, proposes to contribute significantly to the scientific agenda of the PACTG. We will continue to enroll large numbers of HIV-1 infected women, children, and adolescents into PACTG sponsored clinical trials. Approximately 150 patients will be enrolled during the first year of the next funding cycle into one or more (1) Primary therapy studies, (2) Opportunistic infection studies, (3) Perinatal intervention trials, (4) Vaccine trials, and (5) Long-term observational protocols. Finally, the Miami Unit will continue to maintain its excellent record in data management. This Network is led by Dr. Gwendolyn Scott (P.I., Dept. of Pediatrics) and Dr. Mary Jo O'Sullivan (Co-PI, Dept. of Obstetrics) both of whom are recognized nationally and internationally for their expertise in HIV infection and have an ongoing leadership role in the PACTG. Dr. Scott will be assisted in these efforts by Drs. Lawrence Friedman and Charles Mitchell who will have the responsibility of overseeing the enrollment of adolescents and children younger than 13 respectively. The PACTG Network will continue to contribute to the scientific agenda of the PACTG by developing new protocols, participating in scientific committees, and assisting in the expansion of the scientific endeavors of the PACTG in the developing world. The University of Miami has been funded by the Fogarty International Center for the last decade and presently has three Fogarty initiatives which provide research training for international fellows (from Brazil, the Dominican Republic, and Zambia) in Pediatric AIDS, Maternal and Child Health, and Medical Informatics. The strength of the Miami Perinatal Research Network relates to (1) the expertise of the faculty and their distinguished record in the conduct of clinical trials, (2) an extensive infrastructure of psychosocial and medical support which has facilitated the enrollment and retention of patients in clinical trials at our site, (3) an outstanding record in data management (4) excellent laboratory support from the PACTG Core Virology Laboratory and an ACTG certified immunology laboratory, (5) a large population of HIV-1 infected women, children, and adolescents, (6) outreach efforts that integrate with community programs, and (7) International collaborations for expansion of clinical trials.
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