International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group

描述（由申请人提供）：国际孕产妇儿童青少年艾滋病临床试验（IMPAACT）组是一个新的领导小组，代表儿童艾滋病临床试验组（PACTG）和艾滋病预防试验网络（HPTN/HIVNET）围产期科学工作组的研究人员合并。该小组将由小组主席，布鲁克斯杰克逊，医学博士，工商管理硕士（约翰霍普金斯）。社会科学系统公司(SSS)协调和运营中心（CORE）。IMPAACT组的统计数据管理中心（SDMC）将是由Terence芬顿，艾德.D（哈佛）领导的SDAC/FSTRF。该小组的中心实验室网络将由Susan Fiscus博士（U北卡罗来纳州）领导。IMPAACT小组的使命是在全球范围内，通过以下方式显著降低孕妇、婴儿、儿童和青少年与艾滋病毒疾病相关的死亡率和发病率： 1)制定和评估安全和成本效益高的阻断母婴传播的方法; 2)评估对感染艾滋病毒的儿童、青少年和孕妇的治疗，包括对合并感染和合并症的治疗和预防; 3)评价预防青少年艾滋病毒性传播的疫苗。 IMPAACT有一个雄心勃勃的科学议程，建议进行28个PACTG，4个HPTN和1个ATN治疗和预防试验（过渡方案），并制定26个新方案。在第一年，我们估计IMPAACT将在发展中国家招募和/或随访约9，434名妇女，儿童和青少年进入23个方案（8个新方案和15个过渡方案），并在美国招募和/或随访1，479名受试者进入19个方案（4个新方案和15个过渡方案）。这些协议将在RFA指定的六个高优先领域中的四个（预防母婴传播、转化研究/药物开发、优化临床管理，包括合并症和疫苗）。由于RFA的要求，预防母乳喂养传播的HIV疫苗试验在PMTCT部分进行了描述和预算，治疗性疫苗试验在转化研究部分进行了描述和预算，青少年和青春期前预防性疫苗试验在疫苗部分进行了描述和预算。

DESCRIPTION (provided by applicant): The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) group is a new Leadership Group representing a merger of investigators from the Pediatric AIDS Clinical Trials Group (PACTG) and the Perinatal Scientific Working Group of the HIV Prevention Trials Network (HPTN/HIVNET). The group will be headed by the group chair, Brooks Jackson, MD, MBA (Johns Hopkins). Social & Scientific Systems, Inc. (SSS), will be the Coordinating and Operations Center (CORE). The Statistical Data Management Center (SDMC) for the IMPAACT group will be SDAC/FSTRF headed by Terence Fenton, Ed.D (Harvard). The Central Laboratory Network for the group will be headed by Susan Fiscus, PhD (U North Carolina).The mission of the IMPAACT group, which is worldwide in scope, will be to significantly decrease the mortality and morbidity associated with HIV disease in pregnant women, infants, children, and adolescents by: 1) Developing and evaluating safe and cost effective approaches for the interruption of mother-to infant Transmission; 2) Evaluating treatments for HIV-infected children, adolescents, and pregnant women, including treatment and prevention of co-infections and co-morbidities; 3) Evaluating vaccines for the prevention of HIV sexual transmission among adolescents. IMPAACT has an ambitious scientific agenda which proposes to carry forward 28 PACTG, four HPTN, and one ATN treatment and prevention trials (transition protocols) and develop 26 new protocols. In the first year, we estimate that IMPAACT will enroll and/or follow approximately 9,434 women, children, and adolescents in developing countries into 23 protocols (eight new and 15 transition protocols) and 1,479 subjects in the United States into 19 protocols (four new and 15 transition protocols). These protocols will be in four of the six RFA-designated high-priority areas (PMTCT, translational research/drug development, optimization of clinical management including co-morbidities, and vaccines). Due to the requirements of the RFA, HIV vaccine trials for prevention of breastfeeding transmission are described and budgeted in the PMTCT section, therapeutic vaccine trials in the translational research section, and HIV prophylactic vaccine trials for adolescents and preadolescents to prevent sexual transmission in the Vaccine section.