CORE--CLINICAL FACILITY

我们将维持一个临床核心，以提供来自 分枝杆菌感染和来自适当对照的实验 研究项目中概述的方案。核心将位于 华盛顿大学艾滋病临床试验中心(ACTU)是一个 NIAID支持的艾滋病临床试验小组的一部分组成单位 (ACTG)。目前，约有400名患者在该单位接受随访 定期转介，每月约有20名新病人获转介 其中约一半人参加了抗逆转录病毒疗法的研究或 治疗艾滋病相关机会性感染的新药物 关于恶性肿瘤的。此外，传染病司还提供 600名艾滋病毒感染者(其中250人为妇女)的初级艾滋病毒核心 它可以作为患者材料的额外来源。这位病人 人口将成为临床材料的来源。所有艾滋病病毒 对患者进行临床分期，并通过检测外周血中CD_4淋巴细胞计数 和HIV血浆RNA。机密注册表使用特定的 作为唯一标识符的识别号。该注册表包括基本 人口统计数据以及艾滋病毒特定分期数据。此外, 所有患者的基线血清样本都是在初始时间获得的。 访问ACTU并将其储存在(零下70摄氏度)以备将来使用 测试。临床核心将在两年内为该计划项目做出贡献 方法：(一)患者的血清、血浆和细胞样本 分枝杆菌感染，分枝杆菌感染的风险，以及 收集相关对照艾滋病病毒感染者和艾滋病患者； (2)将维护保密的患者数据库，以允许程序 调查人员何时获得临床和其他实验室相关信息 需要的。这应该允许调查人员将结果与 艾滋病毒感染阶段，并仔细匹配阶段的控制 疾病、相互竞争的疾病和治疗。

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.