LC - IMPAACT Leadership Group

说明（由申请人提供）：国际母婴青少年艾滋病临床试验网络（IMPAACT）的指定实验室是该网络成功确定感染艾滋病毒的孕妇、儿童和青少年护理标准的组成部分。IMPAACT实验室研究阐明了艾滋病毒传播的发病机制，改进了阻断母婴传播（MTCT）的策略，优化了即使在多重耐药情况下的艾滋病毒治疗，并加强了艾滋病毒相关并发症的诊断、预防和管理。这些实验室在开发和评价用于婴儿诊断、病毒载量监测、耐药性、抗逆转录病毒药理学、宿主遗传学和免疫反应测量的检测方法方面一直处于领先地位。这些研究是在我们的研究人群和资源有限的国际环境中可获得的小血容量的限制下进行的。通常已经开发出新的方法和新方法，以适应从婴儿、儿童和孕妇获得的有限标本。此外，所有的实验室研究都是在全面的全面质量管理计划下进行的，以确保实验室测试的最高标准。IMPAACT网络实验室中心（LC）由Grace Aldrovandi医学博士领导，她将与IMPAACT领导小组、实验室指导委员会和外部咨询委员会密切合作，以支持、协同和加强IMPAACT科学议程。LC有两个总体的具体目标：(1)提供基于实验室的科学领导，咨询和实验室能力，包括开发和实施创新的分析和协议，以加强影响行动的研究议程和七个科学目标。(2)为支持IMPAACT临床试验的所有实验室测试提供技术、法规和行政基础设施和监督。

DESCRIPTION (provided by the applicant): The designated laboratories of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network have been integral to its success in defining the standards of care for HIV infected pregnant women, children and adolescents. IMPAACT laboratory studies have elucidated the pathogenesis of HIV transmission, improved strategies designed to interrupt mother-to-child transmission (MTCT), optimized HIV treatment even in the setting of multi-drug resistance, and enhanced the diagnosis, prevention and management of HIV-related complications. The laboratories have been leaders in the development and evaluation of assays for infant diagnosis, viral load monitoring, drug resistance, antiretroviral pharmacology, host genetics and the measurement of immune responses. These studies were performed within the constraints of the small blood volumes available from our study populations and internationally in resource-limited settings. Often new methodologies and novel approaches have been developed to accommodate the limited specimens available from infants, children and pregnant women. In addition, all laboratory studies were performed under a comprehensive Total Quality Management Program that assured the highest standards of laboratory testing. The IMPAACT Network Laboratory Center (LC) is led by Grace Aldrovandi MD, CM, who will work closely with the IMPAACT Leadership Group, the Laboratory Steering Committee and the External Advisory Board to support, synergize and enhance the IMPAACT scientific agenda. The LC has 2 overarching specific aims: (1) Provide laboratory-based scientific leadership, consultation and laboratory capacity, including the development and implementation of innovative assays and protocols to enhance IMPAACT's Research Agenda and seven scientific aims. (2) Provide the technical, regulatory and administrative infrastructure and oversight for all laboratory testing done in support of IMPAACT clinical trials. RELEVANCE: The Laboratory Center will provide laboratory-based scientific leadership, consultation and laboratory capacity, to enhance IMPAACT's Research Agenda and achieve its Scientific Aims. It will also provide the technical, regulatory and administrative infrastructure ad oversight for all laboratory testing done in support of IMPAACT clinical trials. Component 1 - Leadership Group Overview