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: 9188522
• 负责人: Grace M Aldrovandi
• 金额: $ 331.27万
• 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/9188522
• 关键词: Adolescent; Anti-Retroviral Agents; Biological Assay; Blood Volume; Caring; Child; Clinical Trials; Consultations; Development; Diagnosis; Drug resistance; Evaluation; Genetic; HIV; Immune response; Infant; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Interruption; 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.

描述（由申请人提供）：国际孕产妇青少年艾滋病临床试验（Impaact）网络的指定实验室在确定艾滋病毒感染的孕妇，儿童和青少年的护理标准方面是不可或缺的。不可思议的实验室研究阐明了艾滋病毒传播的发病机理，改进了旨在中断母亲到孩子传播（MTCT）的策略，即使在多药耐药性的情况下也优化了HIV治疗，并增强了与HIV相关并发症的诊断，预防和管理。这些实验室一直是婴儿诊断，病毒负荷监测，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婴儿诊断，耐药性，耐药性，耐药性，耐药性，耐药性，耐药性，抗药性，抗药性和评估的领导者。这些研究是在我们的研究人群中可获得的小血量的限制下进行的，并在资源有限的环境中进行了国际。通常开发了新的方法和新方法，以适应婴儿，儿童和孕妇可获得的有限标本。此外，所有实验室研究均在一项全面的全质量管理计划下进行，该计划确保了实验室测试的最高标准。 Indaact网络实验室中心（LC）由CM的Grace Aldrovandi MD领导，他将与Inmact Leaderslion Group，实验室指导委员会和外部咨询委员会紧密合作，以支持，协同和增强不可思议的科学议程。 LC具有2个总体特定目的：（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测定和协议，以增强Impaact的研究议程和七个科学目标。 （2）为所有用于支持Inbaact临床试验的实验室测试提供技术，监管和行政基础设施和监督。