International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group

国际孕产妇儿科青少年艾滋病临床试验（IMPAACT）小组

• 批准号: 8136820
• 负责人: J BROOKS JACKSON
• 金额: $ 120.46万
• 依托单位: SOCIAL AND SCIENTIFIC SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-13 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8136820
• 关键词: AIDS clinical trial group; AIDS prevention; Adolescent; Area; Breast Feeding; Budgets; Child; Clinical Management; Comorbidity; Developing Countries; Disease; Doctor of Philosophy; Enrollment; HIV; HIV prevention trials network; HIV vaccine; Head; Infant; Infection; International Maternal Pediatric Adolescent AIDS Clinical Trials; International Maternal Pediatric Adolescent AIDS Clinical Trials Group; Interruption; Laboratories; Leadership; Mission; Morbidity - disease rate; Mothers; North Carolina; Perinatal; Pregnant Women; Prevention; Protocols documentation; Research Personnel; Sexual Transmission; System; Translational Research; United States; Vaccines; Woman; cost effective; data management; drug development; mortality; operation; pediatric AIDS; prevent; prophylactic; social; therapeutic vaccine; transmission process; working group

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.

描述（由申请人提供）：国际孕产妇儿科青少年艾滋病临床试验 (IMPAACT) 小组是一个新的领导小组，由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而成。该小组将由小组主席 Brooks Jackson（医学博士、工商管理硕士（约翰霍普金斯大学））领导。 Social & Scientific Systems, Inc. (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，由特伦斯·芬顿 (Terence Fenton) 教育博士（哈佛大学）领导。该小组的中央实验室网络将由 Susan Fiscus 博士（北卡罗来纳大学）领导。IMPAACT 小组的使命是在全球范围内，通过以下方式显着降低孕妇、婴儿、儿童和青少年中与艾滋病毒相关的死亡率和发病率： 1) 开发和评估安全且具有成本效益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，包括合并感染和合并症的治疗和预防； 3) 评估预防青少年艾滋病毒性传播的疫苗。 IMPAACT 制定了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 23 个方案（8 个新方案和 15 个过渡方案）中招募和/或跟踪发展中国家的约 9,434 名妇女、儿童和青少年，并在美国将 1,479 名受试者纳入 19 个方案（4 个新方案和 15 个过渡方案）。这些协议将涉及 RFA 指定的六个高优先领域中的四个（PMTCT、转化研究/药物开发、包括合并症在内的临床管理优化和疫苗）。根据 RFA 的要求，用于预防母乳喂养传播的 HIV 疫苗试验在 PMTCT 部分进行描述和预算，治疗性疫苗试验在转化研究部分进行描述，针对青少年和青春期前儿童预防性传播的 HIV 预防性疫苗试验在疫苗部分进行描述和预算。