CORE--CLINICAL RESEARCH

核心--临床研究

• 批准号: 6203475
• 负责人: John P Phair
• 金额: $ 17.33万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-01 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6203475
• 关键词: AIDS; AIDS therapy; HIV infections; antiAIDS agent; biomedical facility; clinical research; combination chemotherapy; dosage; human therapy evaluation; human tissue; outcomes research; patient /disease registry; pharmacokinetics; sample collection; tissue resource /registry

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.

临床研究核心将支持采集标本， 通过招募和 管理HIV-1感染者， 在NIH申办的自然史中登记的实验室资料， 治疗试验：密集的、系统的血液采样，脑 脊髓液、生殖器分泌物和淋巴组织;细致的标本 处理;以及这些样本的储存库储存和库存 在适当的条件下。临床研究核心的资源 不会与艾滋病诊所的支助重叠或取代艾滋病诊所的支助。 试验组（ACTG）或多中心AIDS队列研究（MACS）相关 治疗试验或方案，或所需的常规血液采样 在这些或其他研究过程中从入组受试者中获得 赞助的研究。临床研究核心将支持新的 抗逆转录病毒联合疗法和基因治疗试验 辅以密集、系统的血液和组织取样的治疗 来自这些NIH赞助的研究中高度选择的参与者， 明确定义的临床和实验室数据的历史以及存储库 临床标本的特征。所有样本采集和 院校内部及院校之间的转校将按照 遵守所有适用的条例和规定，以确保基本健康， 安全标准西北大学的John Phair博士将担任 临床研究中心主任，并将监督所有临床 研究活动，目标是协同协调 CFAR调查人员的活动和需求。亨利贝尔福博士和 Robert Murphy将担任临床研究核心的联合主任， 分别是西北大学和明尼苏达大学。的 临床研究中心将设计、开发和实施抗逆转录病毒药物 和基因治疗方案与发起中心合作 研究人员、生物统计学核心和药理学资源单位， 后者由考特尼弗莱彻和莱斯特·德鲁维斯博士指导 明尼苏达大学的教授西北大学的查尔斯班尼特博士 大学将负责确定结果测量。