This application entitled """"""""University of Miami Pediatric /Perinatal HIV/AIDS Clinical Trial 5 Unit"""""""" proposes a Clinical Trials Unit made up of an Administrative Core and a Clinical Research Site aligned with the IMPAACT Network with Dr. Gwendolyn Scott as the Principal Investigator and Dr. Chares Mitchell as the Site Leader. This is a collaboration between Pediatrics, Obstetrics and Adolescent Medicine to provide access to clinical trials for HIV infected pregnant women, infants, children and youth. Tie CTU investigators have a distinguished past record of accomplishments in HIV/AIDS clinical trials over the past 17 years. In particular, this site has made significant contributions to the reduction of HIV perinatal transmission in the US. The scientific priorities of the proposed CTU are as follows: 1. Prevention of Mother to Infant Transmission, 2. Translational Research/Drug Development, 3. Optimization of Clinical Management, Including Co-Morbidities, and 4. Vaccines. The focus of the clinical research activities proposed is primarily domestic. Miami-Dade County has a large population of HIV infected women and children and many of the infected individuals are members of minority populations. Many of these infected children, youth and pregnant women receive care at the University of Miami (UM). We will be able to comply with the requirements of the minimum 20/month average case load. The strengths of the UM Podiatric/Perinatal IMPAACT Unit are: 1. the expertise of the faculty and their record in conducting clinical trials since 1987, 2. the past and potential future scientific contributions of the investigators, 3. the strong collaboration between Pediatrics, Obstetrics and Adolescent Medicine, 4. good retention of study subjects, 5. an exemplar/ record in data management, 6. a large population of potential study subjects in all three areas;children, adolescents, and pregnant women, 7. excellent laboratory support, 8. outreach efforts which integrate with community programs, and 9. a long history of international collaborative research initiatives. This application will provide access to new drugs and drug combinations, immune based therapies, such as vaccines and other interventions for treating infants, children, adolescents and pregnant women with HIV infection. It will also provide further research on preventative strategies, such as vaccines and medications to reduce mother to child transmission both in the US and internationally. ADMINISTRATIVE COMPONENT:
