LOC-IMPAACT Leadership Group

描述（由申请人提供）：国际母婴青少年艾滋病临床试验（IMPAACT）网络将由约翰霍普金斯大学的医学博士、MBA布鲁克斯·杰克逊领导，他是领导和运营中心的负责人，国际家庭健康组织是运营中心。IMPAACT统计与数据管理中心将由哈佛大学公共卫生学院David Shapiro博士领导，前沿科学与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。影响行动的使命是减少艾滋病毒和与艾滋病毒相关的事件

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.