LOC-IMPAACT Leadership 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）网络将由约翰霍普金斯大学医学博士、工商管理硕士布鲁克斯杰克逊领导，他是领导和运营中心的PI，国际家庭健康组织是运营中心。IMPAACT统计和数据管理中心将由哈佛大学公共卫生学院的大卫夏皮罗博士领导，前沿科学技术研究基金会作为数据管理中心。南加州大学医学博士Grace Aldrovandi将领导IMPAACT实验室中心。IMPAACT的使命是减少艾滋病毒和艾滋病毒相关疾病的发生， 艾滋病毒/艾滋病是艾滋病毒/艾滋病的主要传播媒介，其目的是减少艾滋病毒感染，包括母婴传播，并降低全世界婴儿、儿童、青少年和孕妇/产后妇女因艾滋病毒和艾滋病毒相关感染及合并症而导致的死亡率/发病率。上述实体将通过开展临床试验来解决和支持5个RFA研究优先领域，以实现以下7个具体目标： 1.评估新的和现有的抗逆转录病毒药物和配方的PK，安全性，药物相互作用，从而为艾滋病毒感染的婴儿，儿童，青少年和孕妇提供最佳剂量和许可。 2.评估艾滋病毒感染儿童结核病预防、治疗和诊断的新方法， 青少年和孕妇。 3.制定和测试生物医学/行为意图，以防止艾滋病毒的孕产妇感染和母婴传播，并防止从围产期感染艾滋病毒的青少年向性伴侣的二次传播。 4.评价HIV感染孕妇及其婴儿、儿童和青少年中优先接种疫苗的免疫原性、安全性和有效性。 5.通过旨在预防和清除感染艾滋病毒的婴儿、儿童和青少年中的艾滋病毒储存库的治疗干预措施，评估治愈艾滋病毒的潜力。 6.在HIV感染的儿童、青少年和孕妇中评价治疗HBV和HCV的新药和药物组合的PK、安全性和疗效。 7.确定预防和管理艾滋病毒感染的合并感染和合并症及其治疗的最佳可行方法。 相关性：许多许可的药物和一些艾滋病毒，结核病和肝炎疫苗未被批准用于孕妇和儿童。通过在这些脆弱人群中进行新药和疫苗的临床试验，我们将确定这些干预措施的安全性、剂量和有效性，以预防和治疗艾滋病毒及其合并症/合并感染，从而降低全球的发病率/死亡率。

DESCRIPTION (provided by applicant): The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network will be led by Brooks Jackson, MD, MBA, of Johns Hopkins U, as PI of the Leadership and Operations Center, with Family Health International as the Operations Center. The IMPAACT Statistical and Data Management Center will be headed by David Shapiro, PhD, Harvard U School of Public Health, with Frontier Science & Technology Research Foundation as the Data Management Center. Grace Aldrovandi, MD, U of Southern California will head the IMPAACT Laboratory Center. IMPAACT's mission is to decrease incident HIV and HIV-associated infections including mother-to-child transmission (MTCT) and to decrease mortality/morbidity due to HIV and HIV-associated infections and co-morbidities among infants, children, adolescents, and pregnant/postpartum women worldwide. The above entities will address and support the 5 RFA research priority areas by conducting clinical trials to achieve the following 7 Specific Aims: 1. Evaluate PK, safety, drug interactions of new and existing ARV agents and formulations leading to optimal dosing and licensing for HIV-infected infants, children, adolescents and pregnant women. 2. Evaluate novel approaches for TB prevention, treatment, and diagnosis in HIV-infected children, adolescents, and pregnant women. 3. Develop and test biomedical/behavioral intentions to prevent HIV maternal acquisition and MTCT and to prevent secondary transmission from perinatally HIV-infected adolescents to sexual partners. 4. Evaluate the immunogenicity, safety, and efficacy of vaccines of high priority in HIV-infected pregnant women and their infants, children, and adolescents. 5. Evaluate the potential for HIV cure through therapeutic interventions aimed at prevention and clearance of HIV reservoirs in HIV-infected infants, children and adolescents. 6. Evaluate the PK, safety, and efficacy of new drugs and drug combinations to treat HBV and HCV in HIV infected children, adolescents, and pregnant women. 7. Determine optimal and feasible methods for the prevention and management of co-infections and comorbidities of HIV infection and its treatment. RELEVANCE: Many licensed drugs and a number of vaccines for HIV, TB, and hepatitis are not approved for use in pregnant women and children. By conducting clinical trials of new drugs and vaccines in these vulnerable populations, we will determine the safety, dosing, and efficacy of these interventions for the prevention and treatment of HIV and its co-morbidities/co-infections thereby reducing morbidity/mortality worldwide.