Study of Tecovirimat for Human Monkeypox Virus (STOMP)

项目摘要 艾滋病临床试验组（ACTG）一直处于临床研究的最前沿， 治疗和改善艾滋病毒/艾滋病患者的健康25年。严谨的科学研究 ACTG进行的这项研究为目前的艾滋病治疗指南奠定了基础。本申请中为了 ACTG网络实验室中心的竞争性更新，我们提出了一个变革性的实验室 研究议程，借鉴了国际联盟的突出临床和实验室研究人员， 与世界一流的统计和数据管理中心合作， 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 审判该组件ACTG网络实验室中心将提高科学知识和技术 通过在NIH/DAIDS的四个优先战略领域提供最先进的实验室支持， 治愈艾滋病毒;改善结核病的诊断和治疗;确定治愈传染性病毒的战略 肝炎;改善与艾滋病毒感染相关的非传染性并发症的治疗和预防 并评估针对艾滋病毒感染的新干预措施。此外，实验室中心将提供 为艾滋病毒/艾滋病和病毒介导的癌症的口腔表现的治疗研究提供实验室支持。的 在国内和国际场所继续扩大有效的、有质量保证的实验室计划， 方案安全措施，病毒学和分枝杆菌学最先进的分子检测;免疫学 和生物标志物;药理学;基因组学;与HIV-1感染相关的口腔病原体，将提供 这是推进ACTG网络科学议程的基本框架。实验室中心将 继续为ACTG网络提供已建立的标本和人类DNA储存库的监督， 与其他网络协调具体的实验室检测和标准化操作程序， 可行，并继续支持国内技术人员和调查人员的实验室培训， 化国际大

PROJECT SUMMARY 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.