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布鲁克斯·杰克逊领导，医学博士，MBA，作为领导和运营中心的PI，以国际家庭健康为运营中心。IMPAACT统计和数据管理中心将由哈佛大学公共卫生学院博士David Shapiro领导，前沿科学和技术研究基金会将作为数据管理中心。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与艾滋病毒相关的事件 该方案旨在减少包括母婴传播在内的感染，并减少因艾滋病毒和艾滋病毒相关感染造成的死亡率/发病率，以及全世界婴儿、儿童、青少年和孕妇/产后妇女的并存率。上述实体将通过开展临床试验来处理和支持RFA的5个优先研究领域，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制剂和配方的PK、安全性、药物相互作用，从而为感染艾滋病毒的婴儿、儿童、青少年和孕妇提供最佳的剂量和许可。 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/行为意向，以防止艾滋病毒母体感染和母婴传播，并防止感染艾滋病毒的青少年向性伴侣的二次传播。 4.评估高优先级疫苗在感染艾滋病毒的孕妇及其婴儿、儿童和青少年中的免疫原性、安全性和有效性。 5.评估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蓄积物的治疗干预措施治愈艾滋病毒的潜力。 6.评估治疗HIV感染的儿童、青少年和孕妇的新药和药物组合的PK、安全性和有效性。 7.确定预防和管理艾滋病毒感染及其治疗的混合感染和并存的最佳可行方法。

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.