AIDS Clinical Trial Group Laboratory Center

摘要 艾滋病临床试验小组(ACTG)一直站在临床研究的前沿，以推动 30多年来，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奠定了基石 治疗指南。在此申请竞标更新ACTG网络 实验室中心，我们提出了一项变革性的实验室研究议程，该议程借鉴了 由著名临床和实验室研究人员组成的国际联盟 世界一流的统计和数据管理中心将开展前沿实验室 研究、测试、化验开发和实验室培训，以支持创新 介入临床试验。ACTG网络实验室中心将提高科学水平 知识和技术能力，通过在四个国家提供最先进的实验室支持 NIH/DAIDS优先领域：抗逆转录病毒疗法(ART)无艾滋病毒缓解，2)新疗法 以艾滋病毒为目标，3)结核病，4)艾滋病毒共病，包括神经系统并发症和 治疗乙肝的方法。继续扩大有效的、有质量保证的实验室计划 国内和国际现场的协议安全措施，最先进的分析 病毒学和结核病、免疫学和生物标志物、药理学和基因组学将 为推进ACTG网络的科学议程提供必要的框架。这个 实验室中心将继续监督已建立的样本和人类DNA ACTG网络的储存库，统一具体的实验室测试和标准化 与其他网络的操作程序，如有可能，并支持实验室培训 国内外的技术专家和调查人员。

ABSTRACT 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 over 30 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 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: antiretroviral therapy (ART) free HIV remission, 2) novel therapeutics targeting HIV, 3) tuberculosis, and 4) HIV co-morbidities, including neurologic complications and hepatitis B cure. The continued expansion of an effective, quality-assured laboratory program at domestic and international sites for protocol safety measures, state-of-the-art assays for virology and tuberculosis, immunology and biomarkers, pharmacology, and genomics 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 support the laboratory training of technologists and investigators domestically and internationally.