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，代表来自儿童艾滋病临床试验小组(PACTG)和艾滋病毒预防试验网络(HPTN/HIVNET)的围产期科学工作组的研究人员的合并。该小组将由小组主席布鲁克斯·杰克逊、医学博士、MBA(约翰·霍普金斯大学)领导。社会与科学系统公司(SSS)将成为协调和运营中心(CORE)。IMPAACT小组的统计数据管理中心(SDMC)将是SDAC/FSTRF，由Terence Fenton，Ed.D(哈佛)领导。该小组的中央实验室网络将由苏珊·费斯库斯博士(U North Carolina)领导。IMPAACT小组的任务是通过以下方式显著降低孕妇、婴儿、儿童和青少年中与艾滋病毒疾病有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)评估感染艾滋病毒的儿童、青少年和孕妇的治疗方法，包括治疗和预防合并感染和合并疾病； 3)评价预防青少年艾滋病毒性传播的疫苗。 该中心有一项雄心勃勃的科学议程，提议推进28项PACTG、4项HPTN和1项ATN治疗和预防试验(过渡方案)，并制定26项新方案。在第一年，我们估计IMPAACT将在发展中国家登记和/或跟随大约9434名妇女、儿童和青少年加入23项议定书(8项新的过渡议定书和15项过渡议定书)，并在美国将1 479名受试者纳入19项议定书(4项新的15项过渡议定书)。这些方案将在RFA指定的六个高优先领域中的四个领域(防止母婴传播、转化研究/药物开发、包括共病在内的临床管理的优化和疫苗)。根据《预防母婴传播法》的要求，预防母婴传播的艾滋病毒疫苗试验在预防母婴传播部分介绍并编入预算，治疗性疫苗试验在转化研究部分说明并编入预算，预防青少年和青春期前艾滋病毒预防疫苗试验在疫苗部分说明和编入预算。

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.