CORE--CLINICAL FACILITY

核心——临床设施

• 批准号: 6201154
• 负责人: William G. Powderly
• 金额: $ 11.18万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 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/6201154
• 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.

我们将维持一个临床核心，以提供患有以下疾病的患者的样本 分枝杆菌感染和实验的适当对照 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中心 (ACTU) NIAID 支持的艾滋病临床试验小组的组成单位 （ACTG）。目前，该科室约有 400 名患者接受随访 定期转诊，每月约有 20 名新患者转诊 其中大约一半参加了抗逆转录病毒治疗或 治疗艾滋病相关机会性感染的新药 的恶性肿瘤。此外，传染病科还提供 600 名艾滋病毒感染者的主要艾滋病毒核心（其中 250 名是女性） 它可以作为患者材料的额外来源。这位患者 人群将作为临床材料的来源。所有艾滋病毒+ 通过测量 CD4 淋巴细胞计数对患者进行临床分期 和 HIV 血浆 RNA。机密注册表是使用特定的 识别号码作为唯一标识符。该注册表包含基本的 人口统计数据以及艾滋病毒特定分期数据。此外， 在初始治疗时获得所有患者的基线血清样本 访问 ACTU 并存储在（-70 摄氏度）以备将来使用 测试。临床核心将在两个方面为该计划项目做出贡献 方法： (i) 感染者的血清、血浆和细胞样本 分枝杆菌感染，有分枝杆菌感染的风险，以及 收集HIV感染者和艾滋病相关对照患者； (ii) 将维护机密患者数据库以允许计划 研究人员在以下情况下获得临床和其他实验室相关信息 需要。这应该允许研究人员将结果与 HIV 感染阶段并仔细匹配该阶段的对照 疾病、竞争性疾病和治疗。