AIDS Clinical Trials Group for Research on Therapeutics for HIV and Related Infections

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/艾滋病感染者的健康30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 竞争性更新的ACTG，我们提出了一个变革性的研究议程，借鉴了 国际领先的临床和实验室HIV研究者联盟与世界一流的 统计和数据管理中心设计和开展创新的干预性临床试验， 显著减少艾滋病毒、结核病和B型肝炎造成的全球疾病负担。 领导与运营中心（Leadership and Operations Center，简称ENC）提供科学的领导力， ACTG的管理。ACTG执行委员会（AEC）将作为 网络的主体。非洲经济共同体由一个执行管理委员会指导， 主席、首席质量官和实验室主席以及统计和数据管理中心。 变革科学小组将监督ACTG研究议程的制定和执行， 该计划将由科学议程指导委员会（SASC）协调和优先考虑。议定书 开发、实施、培训和网络评估将由网络临床核心促进， 社会科学系统公司该公司的财务管理小组（管理核心）在大学的 加州、洛杉矶将在 AEC.该委员会将确保社区参与ACTG的各个方面，并将协调 网络的所有三个组件之间的通信。本提案的具体目标包括：1）确定 在没有抗逆转录病毒疗法的情况下，采取干预措施减少艾滋病毒储存库并控制艾滋病毒复制; 2）检测新的和 针对艾滋病毒感染的持久干预措施; 3）改善药物敏感和药物滥用的治疗和预防 4）预防或改善艾滋病毒相关的非感染性合并症的治疗， 评估治疗HIV感染者和非HIV感染者的B型肝炎病毒感染的策略。

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 people living with HIV/AIDS for 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 we propose a transformative research agenda that draws on an international consortium of leading clinical and laboratory HIV investigators in collaboration with a world-class Statistics and Data Management Center to design and conduct innovative interventional clinical trials that will significantly reduce the global burden of disease due to HIV, TB and hepatitis B. The Leadership and Operations Center (LOC) provides scientific leadership and fiscal and organizational management of the ACTG. The ACTG Executive Committee (AEC) will serve as the overarching governing body of the network. The AEC is guided by an Executive Management Committee that includes the Network Chairs, Chief Quality Officer and the Chairs of the Laboratory and Statistical and Data Management Centers. Transformative Science Groups will oversee the development and execution of the ACTG research agenda, which will be coordinated and prioritized by the Scientific Agenda Steering Committee (SASC). Protocol development, implementation, training and network evaluation will be facilitated by the Network Clinical Core at Social & Scientific Systems, Inc. The LOC financial management group (Admin Core) at the University of California, Los Angeles will oversee resource management and protocol fund distribution at the direction of the AEC. The LOC will assure the engagement of Community in all aspects of the ACTG, and will coordinate communication between all three components of the network. Specific aims of this proposal include: 1) Identify interventions to reduce HIV reservoirs and control HIV replication in the absence of ART; 2) Test novel and durable interventions targeting HIV infection; 3) Improve the treatment and prevention of drug sensitive and drug resistant tuberculosis; 4) Prevent or improve the treatment of HIV-related non-infectious co-morbidities and evaluate strategies to cure hepatitis B virus infection in people with and without HIV.