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.

我们将维持一个临床中心，提供来自以下患者的样本： 分枝杆菌感染和适当的控制， 研究项目中列出的协议。核心将位于 华盛顿大学艾滋病临床试验单位（ACTU）是一个 美国国家艾滋病研究所支持的艾滋病临床试验小组的组成部分 （ACTG）。目前，大约有400名患者在该单位接受随访， 每月约有20名新病人转诊 其中约一半参加了抗逆转录病毒治疗研究， 治疗艾滋病相关机会性感染的新药 恶性肿瘤此外，传染病科还提供 为600名艾滋病毒感染者（其中250名为妇女）提供艾滋病毒初级核心服务 其可以作为患者材料的附加来源。该患者 人群将作为临床材料的来源。所有艾滋病毒阳性 患者临床分期和通过测量CD 4淋巴细胞计数 和HIV血浆RNA。使用特定的 识别号码作为唯一的标识符。该注册表包括基本的 人口统计学数据以及HIV特异性分期数据。此外，本发明还提供了一种方法， 在初始给药时获得所有患者的基线血清样品。 访问ACTU并储存在（-70摄氏度）下，以备将来使用 试验.临床核心将有助于该计划项目在两个 方法：（一）血清，血浆和细胞的样品从患者感染 分枝杆菌感染，有分枝杆菌感染的风险，以及 收集相关的HIV感染者和艾滋病对照患者; (ii)将维护保密的患者数据库， 研究者获得临床和其他实验室相关信息， needed.这将使研究人员能够将结果与 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。