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/围产期艾滋病毒/艾滋病临床试验5单元”的申请提出了一个临床试验单元，该临床试验单元由一个行政核心和一个与IMPAACT网络一致的临床研究站点组成，Gwendolyn Scott博士为首席研究员，charles 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，目的是为感染艾滋病毒的孕妇、婴儿、儿童和青年提供临床试验的机会。在过去的17年里，CTU的研究人员在艾滋病毒/艾滋病临床试验方面取得了杰出的成就。特别是，该网站为减少美国艾滋病毒围产期传播做出了重大贡献。建议的CTU的科学重点如下：预防母婴传播；2。3.转化研究/药物开发；3 .优化临床管理，包括合并症；疫苗。临床研究活动的重点主要是国内。迈阿密-戴德县有大量感染艾滋病毒的妇女和儿童，其中许多感染者是少数民族人口。这些受感染的儿童、青年和孕妇中有许多在迈阿密大学接受治疗。我们将能够满足最低20/月平均箱量的要求。UM足病/围产期影响股的优势是：1。教师的专业知识和他们自1987年以来进行临床试验的记录。2 .研究人员过去和未来的科学贡献；3 .儿科、产科和青少年医学的紧密合作；4 .对学习科目的记忆力好；数据管理的典范/记录；在这三个领域都有大量潜在的研究对象；儿童、青少年和孕妇；优秀的实验室支持；与社区项目相结合的拓展工作；国际合作研究计划的悠久历史。这项申请将使人们能够获得新的药物和药物组合、免疫疗法，如疫苗和其他干预措施，以治疗感染艾滋病毒的婴儿、儿童、青少年和孕妇。它还将提供有关预防策略的进一步研究，例如在美国和国际上减少母婴传播的疫苗和药物。

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: