International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Laboratory Center

国际孕产妇儿科青少年艾滋病临床试验（IMPAACT）实验室中心

• 批准号: 9317270
• 负责人: Grace M Aldrovandi
• 金额: $ 178.08万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-16 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9317270
• 关键词: Adolescent; Antiretroviral drug resistance; Biological Assay; Blood Volume; Caring; Child; Clinical Trials; Clinical Trials Network; Consultations; Development; Diagnosis; Evaluation; Genetic; HIV; Immune response; Infant; International Maternal Pediatric Adolescent AIDS Clinical Trials; Laboratories; Laboratory Study; Leadership; Measurement; Methodology; Monitor; Multi-Drug Resistance; Pathogenesis; Pharmacology; Pregnant Women; Prevention; Protocols documentation; Research; Research Infrastructure; Resources; Specimen; Testing; Total Quality Management; Vertical Disease Transmission; Viral Load result; Work; base; design; high standard; improved; innovation; novel strategies; programs; study population; success; transmission process

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

说明(由申请人提供)：国际母婴青少年艾滋病临床试验网络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不可或缺的一部分。该中心的实验室研究阐明了艾滋病毒传播的机制，改进了旨在阻断母婴传播的战略，优化了艾滋病毒治疗，即使在出现多药耐药的情况下也是如此，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测试开发和评估方面一直处于领先地位。这些研究是在我们的研究人群和国际上资源有限的环境中可获得的小血量的限制下进行的。为了适应婴儿、儿童和孕妇提供的有限标本，往往开发了新的方法和新的方法。此外，所有实验室研究都是在全面质量管理计划下进行的，该计划确保了实验室测试的最高标准。亚太技转中心网络实验室中心由格雷斯·奥尔德罗万迪博士领导，他将与亚太技转中心领导小组、实验室指导委员会和外部咨询委员会密切合作，以支持、协同和加强亚太技转中心的科学议程。该委员会有两个最重要的具体目标：(1)提供以实验室为基础的科学领导、咨询和实验室能力，包括开发和实施创新的分析方法和方案，以加强研究所的研究议程和七个科学目标。(2)为支持IMPAACT临床试验而进行的所有实验室检测提供技术、监管和行政基础设施和监督。 相关性：实验室中心将提供以实验室为基础的科学领导、咨询和实验室能力，以加强IMPAACT的研究议程并实现其科学目标。它还将为支持IMPAACT临床试验的所有实验室测试提供技术、监管和行政基础设施和监督。 组成部分1-领导班子概述