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

艾滋病临床试验组（ACTG）实验室中心；

• 批准号: 8554612
• 负责人: Robert W. Coombs
• 金额: $ 636.69万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8554612
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Affect; Area; Biological Assay; Biological Markers; Clinical; Clinical Research; Clinical Trials; Collaborations; Comorbidity; DNA Repository; Diagnosis; Genomics; Guidelines; HIV; HIV Infections; HIV-1; Health; Immunology; Infection; International; Intervention; Knowledge; Laboratories; Laboratory Research; Laboratory Study; Lead; Life; Malignant Neoplasms; Measures; Mediating; Molecular; Morbidity - disease rate; Oral Manifestations; Patients; Pharmacology; Population; Prevention; Procedures; Protocols documentation; Research; Research Personnel; Safety; Scientific Advances and Accomplishments; Site; Specimen; Testing; Therapeutic; Therapeutic Studies; Training; Training Support; Tuberculosis; United States National Institutes of Health; Viral hepatitis; assay development; data management; human DNA; improved; innovation; mortality; novel; oral pathogen; programs; tuberculosis treatment; virology

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

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，致力于推进艾滋病毒治疗并改善艾滋病毒/艾滋病患者的健康。 ACTG 进行的严格科学研究为当前的艾滋病毒治疗指南奠定了基石。在 ACTG 网络实验室中心竞争性更新的申请中，我们提出了一项变革性实验室研究议程，该议程利用由著名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，开展前沿实验室支持创新介入临床试验的研究、测试、分析开发和实验室培训。 ACTG 网络实验室中心的组成部分将通过在 NIH/DAIDS 治疗艾滋病毒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；改进结核病的诊断和治疗；确定治疗传染性病毒性肝炎的策略；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/艾滋病口腔表现和病毒介导的癌症的治疗研究提供实验室支持。在国内和国际地点继续扩大有效、有质量保证的实验室计划，以实施方案安全措施、最先进的病毒学和分枝杆菌学分子测定；免疫学和生物标志物；药理;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。实验室中心将继续对 ACTG 网络已建立的样本和人类 DNA 存储库进行监督，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，并继续支持国内外技术人员和研究人员的实验室培训。 相关性：本申请中提出的实验室研究将对全球数百万感染艾滋病毒、结核病和病毒性肝炎的患者的健康产生直接有益的影响，从而改变这些感染患者的治疗方法。 ACTG 进行的临床研究将显着降低发病率和死亡率，特别是在受艾滋病毒/艾滋病和结核病影响较大的人群中