AIDS Clinical Trials Group Network

描述(由申请人提供)：艾滋病临床试验小组(ACTG)的使命是开发和进行科学严格的翻译研究和治疗临床试验，以：1)调查HIV-1感染及其并发症的病毒和免疫发病机制；2)评估新的治疗药物以及使用现有药物治疗HIV-1感染的最有效方法和策略；3)评价治疗和预防艾滋病毒相关机会性感染、合并感染、治疗并发症和其他艾滋病毒-1相关并发症的干预措施和战略；4)出版和传播这些研究的结果，以改善临床护理，预防或延缓艾滋病毒疾病的发展，减少或消除与艾滋病毒-1感染及其相关并发症有关的发病率和死亡率。在这项申请中，ACTG提出了一个全面、综合的临床和转化性研究计划，涉及本RFA概述的六个科学领域中的五个：1)转化性研究和药物开发；2)优化临床管理，包括联合感染；3)疫苗研发；4)预防母婴传播；5)预防艾滋病毒感染。一项口腔健康计划将与国家牙科和颅面研究所支持的研究人员合作进行。该方案将与艾滋病毒预防试验网络(HPTN)、艾滋病毒疫苗试验网络(HPTN)、IMPAACT网络和杀微生物剂试验网络(MTN)合作实施。拟议的研究议程以及小组领导和组织结构反映了艾滋病毒流行病在世界范围内的影响。我们建议利用美国和非洲、亚洲、拉丁美洲和加勒比地区12个国家的72个临床研究地点网络进行这项工作。该网络得到核心实验室综合网络的积极支持，该网络在病毒学、药理学、免疫学和基因组学方面具有广泛的专业知识。位于马里兰州银泉市的ACTG运营中心提供关键的运营、行政和财务支持。统计专业知识和数据管理资源由位于马萨诸塞州波士顿和纽约州布法罗的统计和数据管理中心提供。 核心(P.I.本森，康斯坦斯) 核心：转化研究/药物开发

DESCRIPTION (provided by applicant): The mission of the AIDS Clinical Trials Group (ACTG) is to develop and conduct scientifically rigorous translational research and therapeutic clinical trials to: 1) investigate the viral and immune pathogenesis of HIV-1 infection and its complications; 2) evaluate novel therapeutic agents and the most effective approaches and strategies for the use of existing agents to treat HIV-1 infection; 3) evaluate interventions and strategies to treat and prevent HIV-related opportunistic infections, co-infections, complications of therapies, and other HIV-1-related co-morbidities, and 4) publish and disseminate the findings from these studies for the purpose of improving clinical care, preventing or delaying HIV disease progression, and reducing or eliminating the morbidity and mortality associated with HIV-1 infection and its associated complications. In this application the ACTG proposes a comprehensive, integrated clinical and translational research program that addresses five of the six scientific areas outlined under this RFA: 1) Translational Research and Drug Development; 2) Optimization of Clinical Management, including Co-Infection; 3) Vaccine Research and Development; 4) Prevention of Mother to Child Transmission, and 5) Prevention of HIV Infection. An Oral Health program will be undertaken in collaboration with investigators supported by the National Institute of Dental and Craniofacial Research. This program will be conducted in collaboration with the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HPTN), the IMPAACT network and the Microbicide Trials Network (MTN). The proposed research agenda as well as the Group Leadership and organizational structure reflect the worldwide impact of the HIV epidemic. We propose to conduct the work using a network of 72 clinical research sites in the United States and 12 countries in Africa, Asia, Latin America and the Caribbean. The network is actively supported by an integrated network of Core Laboratories with broad expertise in virology, pharmacology, immunology, and genomics. The ACTG Operations Center, located in Silver Spring, MD, provides key operational, administrative, and fiscal support. Statistical expertise and data management resources are provided by the Statistics and Data Management Center in Boston, MA and Buffalo, NY. CORE (P.I. Benson, Constance) CORE: Translational Research/Drug Development