CORE--CLINICAL FACILITY

核心——临床设施

• 批准号: 6649912
• 负责人: William G. Powderly
• 金额: $ 28.97万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6649912
• 关键词: AIDS; Actinomycetales infection; HIV infections; Mycobacterium avium; biomedical facility; clinical research; human subject; opportunistic infections; patient /disease registry; tissue resource /registry

We will maintain a clinical core to provide specimens from patients with mycobacterial infection and from appropriate controls for the experimental protocols outlined in the research projects. The core will be located at the Washington University AIDS Clinical Trials Unit (ACTU) which is a component unit of part of the NIAID-supported AIDS Clinical Trials Group (ACTG). Currently, approximately 400 patients are followed at the unit on a regular basis and approximately 20 new patients are referred each month about half of whom are enrolled on studies on antiretroviral therapy or of new agents for the treatment of AIDS-associated opportunistic infections of malignancies. In addition the Division of Infectious Diseases provide primary HIV core for 600 HIV infected patients (250 of whom are women) which can act as an additional source of patient material. This patient population will serve as the source of clinical material. All HIV+ patients are staged clinically and by measured of the CD4 lymphocyte count and HIV plasma RNA. A confidential registry is maintained using a specific identifying number as the sole identifier. This registry comprises basic demographic data as well as the HIV-specific staging data. In addition, baseline serum samples are obtained on all patients at the time of initial visit to the ACTU and stored at (-70 degrees Celsius) for possible future testing. The clinical core will contribute to the program project in two ways: (i) Samples of serum, plasma and cells from patients infected with mycobacterial infections, at risk for mycobacterial infections, and relevant control patients with HIV infection and AIDS will be collected; (ii) the confidential patient database will be maintained to allow program investigators to obtain clinical and other laboratory correlates when needed. This should allow investigators to correlate results with the stage of HIV infection and to carefully match controls for stage of disease, competing illnesses and therapy.

我们将维持临床核心，以提供患者的标本 分枝杆菌感染和实验的适当控制 研究项目中概述的协议。核心将位于 华盛顿大学艾滋病临床试验部（ACTU）是 NIAID支持的AIDS临床试验组的一部分组件单位 （ACTG）。目前，该单位约有400名患者 定期和大约20名新患者被转介 大约一半正在参加抗逆转录病毒疗法的研究或 用于治疗艾滋病相关的机会感染的新代理 恶性肿瘤。此外，传染病的分裂提供 600例HIV感染患者的原发性HIV核心（其中250名是女性） 可以充当患者材料的其他来源。这个病人 人口将作为临床材料的来源。所有艾滋病毒+ 患者在临床上进行分期，并测量CD4淋巴细胞计数 和HIV血浆RNA。使用特定的 将数字识别为唯一标识符。该注册表包括基本 人口统计数据以及HIV特定的分期数据。此外， 初始患者获得所有患者的基线血清样品 访问Actu，并存储在（-70摄氏度）中，以了解未来 测试。临床核心将在两个方面为计划项目做出贡献 方法：（i）感染患者的血清，血浆和细胞样本 分枝杆菌感染，有分枝杆菌感染的风险， 将收集有关HIV感染和艾滋病的相关对照患者； （ii）将保留机密的患者数据库以允许程序 研究人员获得临床和其他实验室的研究 需要。这应该允许研究人员将结果与 艾滋病毒感染的阶段，并仔细匹配控制阶段 疾病，竞争疾病和治疗。