AIDS CLINICAL TRIAL UNIT

艾滋病临床试验单位

• 批准号: 3547988
• 负责人: Harvey Michael Friedman
• 金额: $ 163.2万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-04-01 至 1996-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3547988
• 关键词: AIDS; AIDS therapy; HIV infections; clinical trials; cooperative study; human subject; human therapy evaluation

This application proposes to establish an adult AIDS Clinical Trials Unit in Philadelphia, combining resources from two major medical centers, the University of Pennsylvania and Thomas Jefferson University. 140 patients/year will be enrolled in clinical trials, 80 at the Hospital of the University of Pennsylvania (HUP) and 60 at Thomas Jefferson University Hospital (TJUH). These include 60-75 with primary HIV infection (enrollment at both centers), 40-60 with opportunistic infections (enrollment at both centers), 10 with HIV related malignancies (enrollment at HUP primarily), and 10 with neurologic complications of HIV disease (enrollment at HUP primarily). The addiction treatment clinic at Girard Medical Center will serve as a site for enrolling HIV infected intravenous drug users (IVDUs). The TJUH group follows a large population of pregnant women who are IVDUs, approximately 15% of whom are HIV infected. The large Hemophiliac Center at TJUH will be a major source of patients for study. Approximately 50% of HIV positive patients treated at our two centers are minorities, and 15-20% are women. We also propose to establish Core laboratories in virology at Penn and pharmacology at Jefferson. The virology lab will perform all protocol mandated viral studies, and in addition quantitative cultures, quantitative PCR, assays to detect HTLV-I or -II infection in IVDUs, and assays to monitor HSV, CMV, and VZV isolates for emergence of resistance to antivirals. The pharmacology lab will provide analytical and pharmacokinetic support for protocols of investigational agents. A developmental virology project is proposed for TJUH that evaluates a new technique, in situ PCR, for detection of HIV-1 genome within intact cells. In addition, quantitative RNA PCR will be used to evaluate changes in HIV transcription that occur in response to therapy. This application brings together experienced investigators and offers a large community of HIV infected patients an opportunity to participate in NIH sponsored clinical trials.

该申请建议建立成人艾滋病临床试验单元 在费城，结合了两个主要医疗中心的资源， 宾夕法尼亚大学和托马斯·杰斐逊大学。 140 患者/年将参加临床试验，80例在医院 宾夕法尼亚大学（HUP）和托马斯·杰斐逊大学60 医院（tjuh）。 其中包括60-75伴有原发性艾滋病毒感染 （两个中心的入学人数），40-60，有机会感染 （这两个中心的入学人数），10个患有HIV相关的恶性肿瘤（入学人数 主要是HUP），有10个患有HIV疾病的神经系统并发症 （主要在HUP入学）。 吉拉德的成瘾治疗诊所 医疗中心将作为注册艾滋病毒感染的静脉注入的地点 吸毒者（IVDUS）。 TJUH组跟随大量怀孕 IVDU的妇女，大约15％的艾滋病毒感染。 大 TJUH的血友病中心将是研究患者的主要来源。 在我们两个中心接受治疗的HIV阳性患者中，约有50％是 少数民族，15-20％是女性。 我们还建议在宾夕法尼亚州建立病毒学核心实验室 杰斐逊的药理学。 病毒学实验室将执行所有协议 授权的病毒研究，此外，定量培养 PCR，检测IVDUS中HTLV -I或-II感染的测定，并进行测定 监视HSV，CMV和VZV分离株，以表明 抗病毒药。 药理学实验室将提供分析和 对研究剂方案的药代动力学支持。 一个 为TJUH提出了发展病毒学项目，该项目评估了一个新的 原位PCR技术，用于检测完整细胞内的HIV-1基因组。 另外，定量RNA PCR将用于评估HIV的变化 响应治疗的转录。 该应用程序汇集了经验丰富的调查人员，并提供了 大型艾滋病毒感染患者有机会参加 NIH赞助的临床试验。