Laboratory Center, AIDS Clinical Trials Group (ACTG); LC 2 / 3

描述（由申请人提供）：25年来，艾滋病临床试验小组（ACTG）一直处于临床研究的前沿，以推进艾滋病毒治疗和改善艾滋病毒/艾滋病患者的健康。ACTG进行的严谨科学研究为目前的艾滋病毒治疗指南奠定了基础。在这个ACTG网络实验室中心竞争性更新的申请中，我们提出了一个变革性的实验室研究议程，利用一个由杰出的临床和实验室研究人员组成的国际联盟，与世界一流的统计和数据管理中心合作，进行前沿的实验室研究、测试、分析开发和实验室培训，以支持创新的介入性临床试验。ACTG网络实验室中心的组成部分将通过在美国国立卫生研究院/艾滋病防治战略的四个优先领域提供最先进的实验室支持，提高科学知识和技术能力；改善结核病的诊断和治疗；确定治疗传染性病毒性肝炎的战略；改善与艾滋病毒感染相关的非传染性合并症的治疗和预防，并评估针对艾滋病毒感染的新干预措施。此外，实验室中心将为艾滋病毒/艾滋病的口腔表现和病毒介导的癌症的治疗性研究提供实验室支持。在国内和国际站点继续扩大有效的、有质量保证的实验室规划，以采取安全措施，进行最先进的病毒学和分枝杆菌学分子分析；免疫学和生物标志物；药理学;基因组学;以及与HIV-1感染相关的口腔病原体，将为推进ACTG网络的科学议程提供基本框架。实验室中心将继续为ACTG网络提供对已建立的标本和人类DNA库的监督，在可行的情况下与其他网络协调具体的实验室测试和标准化操作程序，并继续支持对国内外技术人员和调查人员进行实验室培训。

DESCRIPTION (provided by applicant): The AIDS Clinical Trials Group (ACTG) has been at the forefront of clinical research to advance HIV therapeutics and improve the health of patients living with HIV/AIDS for 25 years. Rigorous scientific research conducted by the ACTG has laid the cornerstones for current HIV treatment guidelines. In this application for the competitive renewal of the ACTG Network Laboratory Center, we propose a transformative laboratory research agenda that draws on an international consortium of prominent clinical and laboratory investigators in collaboration with a world-class Statistical and Data Management Center to conduct leading edge laboratory research, testing, assay development and laboratory training for the support of innovative interventional clinical trials. The component ACTG Network Laboratory Center will improve scientific knowledge and technical capability by providing state-of-the-art laboratory support in the four NIH/DAIDS priority areas of strategies to cure HIV; improve the diagnosis and treatment of tuberculosis; identify strategies to cure infectious viral hepatitis; improve the treatment and prevention of non-infectious co-morbidities associated with HIV infection and evaluate novel interventions targeting HIV infection. In addition, the Laboratory Center will provide laboratory support for therapeutic studies of oral manifestations of HIV/AIDS and virally mediated cancers. The continued expansion of an effective, quality-assured laboratory program at domestic and international sites for protocol safety measures, state-of-the-art molecular assays for virology and mycobacteriology; immunology and biomarkers; pharmacology; genomics; and oral pathogens associated with HIV-1 infection, will provide the essential framework for advancing the scientific agenda of the ACTG Network. The Laboratory Center will continue to provide oversight of established specimen and human DNA repositories for the ACTG Network, harmonize specific laboratory testing and standardized operating procedures with other Networks where feasible and continue to support the laboratory training of technologists and investigators domestically and internationally. RELEVANCE: The laboratory studies proposed in this application will have a direct beneficial effect on the health of millions of patients worldwide who are infected with HIV, TB and viral hepatitis, transforming the treatment of patients with these infections. The clinical research conducted by the ACTG will lead to significantly reducing morbidity and mortality, particularly among populations disproportionately affected by HIV/AIDS and tuberculosis