University of Miami Pediatric Perinatal HIV/AIDS Clinical Trails Unit

描述(由申请人提供)：这份题为“迈阿密大学儿科/围产期HIV/AIDS临床试验5单元”的申请书建议建立一个临床试验单元，该单元由一个行政核心和一个临床研究站点组成，该站点与IMPAACT网络保持一致，Gwendolyn Scott博士为首席研究员，Chares Mitchell博士为站点负责人。这是儿科、产科和青少年医学之间的合作，旨在为感染艾滋病毒的孕妇、婴儿、儿童和青年提供临床试验。TIE CTU调查人员在过去17年中在艾滋病毒/艾滋病临床试验中取得了卓越的成就。特别是，这个网站为减少美国艾滋病毒的围产期传播做出了重大贡献。拟议的CTU的科学优先事项如下：1.预防母婴传播；2.转译研究/药物开发；3.优化临床管理，包括共病；4.疫苗。建议的临床研究活动的重点主要是国内的。迈阿密-戴德县有大量感染艾滋病毒的妇女和儿童，许多感染者是少数族裔人口的成员。许多受感染的儿童、青年和孕妇在迈阿密大学(UM)接受治疗。我们将能够遵守最低20个/月平均案件负荷的要求。UM儿科/围产期IMPAACT单位的优势是：1.自1987年以来在进行临床试验方面的专业知识和他们的记录，2.研究人员过去和未来潜在的科学贡献，3.儿科、产科和青少年医学之间的强大合作，4.研究对象的良好保留，5.数据管理方面的典范/记录，6.所有三个领域的大量潜在研究对象；儿童、青少年和孕妇，7.出色的实验室支持，8.与社区计划相结合的外联努力，以及9.国际合作研究倡议的悠久历史。这一应用将为治疗感染艾滋病毒的婴儿、儿童、青少年和孕妇提供新药和药物组合、基于免疫的疗法，如疫苗和其他干预措施。它还将提供关于预防策略的进一步研究，如疫苗和药物，以减少美国和国际上的母婴传播。 管理组件：

DESCRIPTION (provided by applicant): 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: