CORE--CLINICAL RESEARCH

临床研究核心将支持为以下目的获取样本 通过招募和研究假说驱动的基于发病机制的研究 对HIV-1感染者的管理具有明确的临床和 实验室档案登记在NIH赞助的自然历史和 治疗试验：密集、系统地采集血液、大脑 脊髓液、生殖器分泌物和淋巴组织.精细标本 加工；以及这些样品的储存库存储和库存 在适当的条件下。临床研究核心资源 不会与艾滋病临床中心的支持重叠或替代 试验小组(ACTG)或多中心艾滋病队列研究(MACS)相关 治疗试验或方案，或所需的常规血液采样 在这些或其他过程中从登记的受试者获得 赞助的研究。临床研究核心将支持小说 抗逆转录病毒联合疗法和基因治疗试验 治疗辅以密集、系统的血液和组织采样 这些由美国国立卫生研究院赞助的研究中高度精选的参与者 明确定义的临床和实验室数据的历史记录以及存储库 具有良好特征的临床标本。所有标本收集和 院校内部和院校之间的转学将根据 所有适用的条例和法规，以确保基本健康和 安全标准。西北大学的约翰·费尔博士将成为 临床研究中心主任，并将监督所有临床 研究活动的目标是协同协调 CFAR调查员的活动和需求。亨利·巴尔弗博士和 罗伯特·墨菲将担任临床研究核心中心的联席主任 分别是西北大学和明尼苏达大学。这个 临床研究核心将设计、开发和实施抗逆转录病毒药物 和基因治疗方案，与启动中心合作 调查人员、生物统计核心和药理学资源股， 后者由考特尼·弗莱彻博士和莱斯特·德鲁斯博士指导 明尼苏达大学的。西北大学的查尔斯·班尼特博士 大学将负责确定结果衡量标准。

THE CLINICAL RESEARCH CORE will support the acquisition of specimens for hypothesis-driven pathogenesis-based studies through recruitment and management of HIV-1-infected individuals with well-defined clinical and laboratory profiles enrolled in NIH-sponsored natural history and therapeutic trials for: intensive, systematic sampling of blood, cerebral spinal fluid, genital secretions and lymphoid tissue; meticulous specimen processing; and the repository storage and inventory of these samples under appropriate conditions. The resources for the Clinical Research Core will not overlap with or substitute for the support of the AIDS Clinical Trials Group (ACTG) or Multicenter AIDS Cohort Study (MACS) related therapeutic trials or protocols, or the required routine sampling of blood obtained from the enrolled subjects during the course of these or other sponsored studies. The Clinical Research Core will support novel therapeutic trials for anti-retroviral combination therapies and gene therapy supplemented by intensive, systematic sampling of blood and tissue from highly selected participants in these NIH-sponsored studies who have a history of well-defined clinical and laboratory data and the repository of well-characterized clinical specimens. All specimen collection and transfer within and between institutions will be conducted in accordance with all applicable ordinance and regulations to ensure basic health and safety standards. Dr. John Phair of Northwestern University will be the director of the Clinical Research Core and will oversee al clinical research activities with the goal to synergistically coordinate the activities and needs of the CFAR investigators. Drs. Henry Balfour and Robert Murphy will be co-directors of the Clinical Research Core at Northwestern University and the University of Minnesota, respectively. The Clinical Research Core will design, develop and implement anti-retroviral and gene therapy protocols in collaboration with the initiating center investigators, the Biostatistics Core and the Pharmacology Resource Unit, the latter under the direction of Drs. Courtney Fletcher and Lester Drewes of the University of Minnesota. Dr. Charles Bennett of Northwestern University will be responsible for determining outcome measurements.