University of Miami Pediatric Perinatal HIV/AIDS Clinical Trails Unit

迈阿密大学儿科围产期艾滋病毒/艾滋病临床试验单位

• 批准号: 8197766
• 负责人: GWENDOLYN Barbara SCOTT
• 金额: $ 215.57万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8197766
• 关键词: AIDS/HIV problem; Adolescent; Adolescent Medicine; Area; Caring; Child; Childhood; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Unit; Collaborations; Communities; Comorbidity; Conduct Clinical Trials; County; Discipline of obstetrics; Drug Combinations; Faculty; Future; HIV; HIV Infections; IMPAACT; Immune; Individual; Infant; International; Intervention; Laboratories; Minority; Mothers; Pediatrics; Perinatal; Pharmaceutical Preparations; Population; Pregnant Women; Prevention; Principal Investigator; Recording of previous events; Research; Research Activity; Research Personnel; Site; Study Subject; Translational Research; Universities; Vaccines; Vertical Disease Transmission; Woman; base; clinical research site; data management; drug development; member; outreach; programs; transmission process

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:

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”的申请提出了一个临床试验单元，该单元由行政核心和与 Gwendolyn 博士的 IMPAACT 网络相一致的临床研究中心组成Scott 担任首席研究员，Chares Mitchell 博士担任站点负责人。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、儿童和青少年提供临床试验的机会。 Tie CTU 的研究人员在过去 17 年的 HIV/AIDS 临床试验中取得了杰出的成就。特别是，该网站为减少美国围产期艾滋病毒传播做出了重大贡献。拟议 CTU 的科学重点如下：1. 预防母婴传播，2. 转化研究/药物开发，3. 优化临床管理，包括合并症，以及 4. 疫苗。拟议的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族裔成员。许多受感染的儿童、青少年和孕妇在迈阿密大学 (UM) 接受护理。我们将能够满足每月平均案件量最少 20 个的要求。 UM 足病/围产期 IMPAACT 部门的优势包括： 1. 教员的专业知识及其自 1987 年以来进行临床试验的记录，2. 研究人员过去和未来潜在的科学贡献，3. 儿科之间的强有力合作，产科和青少年医学，4. 研究对象的良好保留，5. 数据管理的范例/记录，6. 所有三个领域都有大量潜在的研究对象；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展工作，以及 9. 国际合作研究倡议的悠久历史。该应用程序将提供新药和药物组合、基于免疫的疗法（例如疫苗）以及用于治疗感染艾滋病毒的婴儿、儿童、青少年和孕妇的其他干预措施。它还将提供有关预防策略的进一步研究，例如减少美国和国际母婴传播的疫苗和药物。 行政部分：