International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group

描述（由申请人提供）：国际母婴青少年艾滋病临床试验（IMPAACT）小组是一个新的领导小组，代表儿科艾滋病临床试验小组（PACTG）和艾滋病毒预防试验网络（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领导，医学博士，MBA（约翰霍普金斯大学）。社会与科学系统公司（SSS）将成为协调和运营中心（CORE）。impact小组的统计数据管理中心（SDMC）将是由哈佛大学教育学博士Terence Fenton领导的SDAC/FSTRF。该小组的中央实验室网络将由Susan fisus博士（北卡罗来纳大学）领导。影响行动小组的任务是在世界范围内大幅度降低孕妇、婴儿、儿童和青少年与艾滋病毒疾病有关的死亡率和发病率，办法是：

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.