COLUMBIA PRESBYTERIAN ACTU

哥伦比亚长老会法案

• 批准号: 3547991
• 负责人: JAY DOBKIN
• 金额: $ 191.96万
• 依托单位: COLUMBIA UNIV NEW YORK MORNINGSIDE
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-02-01 至 1996-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3547991
• 关键词: AIDS; AIDS therapy; African American; HIV infections; Hispanic Americans; antitubercular agents; cell sorting; cervix neoplasms; clinical trials; cooperative study; drug resistance; drug screening /evaluation; female; human subject; human therapy evaluation; neurologic manifestations; neuropsychology; opportunistic infections; tuberculosis; urban poverty area

We propose to establish the Columbia-Presbyterian AIDS Clinical Trials Unit which will include a subunit site at Harlem Hospital Center. The upper Manhattan region of New York City served by these two institutions and their satellite ambulatory care facilities is densely populated by black and Hispanic populations afflicted by poverty, drug abuse and extraordinarily high rates of HIV infection and AIDS. The Columbia- Presbyterian ACTU will be based within the established AIDS treatment and research units of the component institutions to assure maximum access to trials especially for their minority poor and female patients. The overall goal is to provide coordinated and comprehensive social, psychological and medical services simultaneously with research activities so that our patients do not have to make a choice between access to advanced AIDS treatments and everyday basic needs such as housing, food and child care. The current AIDS inpatient, ambulatory care and research programs at the Columbia-Presbyterian Medical Center and Harlem Hospital serve a combined population eligible for clinical trials which has the following characteristics: approximately 1500 active patients, one third each with AIDS, AIDS-related complex and asymptomatic HIV infection; 90% of black or Hispanic ethnic origin; and 40% women. The Columbia-Presbyterian ACTU will draw together an extensive array of clinical and research resources at the College of Physicians and Surgeons of Columbia University and its affiliates Presbyterian and Harlem Hospitals. Close collaboration with Columbia's Pediatric ACTU and Women-Infants Transmission Study (WITS) will facilitate access to treatment trials for the HIV infected women involved in these programs. The existing core laboratories for flow cytometry and virology which were established for these programs will be incorporated into the proposed adult ACTU to maximize efficiency and enhance scientific productivity of all the AIDS programs involved. Neurology will be a special area of concentration for the Columbia- Presbyterian ACTU. Neurologists at Columbia who will play a central role in ACTU activities have developed expertise and resources related to neurobehavioral features of HIV infection in several demographic subgroups including Hispanics, blacks, women and Iv drug users through the NIMH-sponsored HIV Center for Clinical and Behavioral Studies. A Core Pharmacology laboratory is proposed which will be based in a Columbia facility experienced in large volume multi-center trials as well as innovative methodologic development. Developmental research proposals are closely linked to major clinical concerns and are based on strong current research efforts in each area: Developmental virology will focus on the molecular pathogenesis of HIV reverse transcriptase resistance to dideoxynucleosides; Developmental Immunology will evaluate in vitro immune functional assays as surrogate markers for antiretroviral drug efficacy; Developmental Pharmacology will examine the cellular pharmacology and therapeutics of intracellular infections in AIDS, especially M. Tuberculosis; and Developmental Research in Endocrinology will evaluate the contribution of endocrine factors in the HIV wasting syndrome.

我们建议建立哥伦比亚总理艾滋病临床试验 单位将包括哈林医院中心的亚基网站。 这 纽约市的曼哈顿上游地区由这两个机构服务 他们的卫星门诊护理设施密集 黑人和西班牙裔人口受到贫困，药物滥用和 艾滋病毒感染和艾滋病的速度非常高。 哥伦比亚 - 长老会ACTU将基于既定的艾滋病治疗 和组件机构的研究单位，以确保最大 尤其是针对少数贫困和女性患者的试验。 总体目标是提供协调和全面的社交 与研究同时心理和医疗服务 活动，以便我们的患者不必在 访问高级艾滋病治疗和日常基本需求，例如 住房，食物和儿童保育。 当前的辅助住院，门诊护理和研究计划 哥伦比亚 - 普里斯林医学中心和哈林医院服务 有资格参加临床试验的总人群，该试验具有以下 特征：大约1500名活跃患者，每人三分之一 使用艾滋病，与艾滋病相关的复合物和无症状的艾滋病毒感染； 90％ 黑人或西班牙族人；和40％的女性。 哥伦比亚长主角Actu将汇集一系列 医师学院的临床和研究资源 哥伦比亚大学外科医生及其会员长老会和 哈林医院。 与哥伦比亚的小儿Actu密切合作 和女性传播研究（WITS）将有助于进入 涉及这些计划的艾滋病毒感染妇女的治疗试验。 现有的流式细胞仪和病毒学核心实验室 为这些程序建立了 拟议的成人Actu提高效率并增强科学的效率 涉及的所有艾滋病计划的生产力。 神经病学将是哥伦比亚 - 长老会Actu。 哥伦比亚的神经科医生将扮演中央 ACTU活动中的作用已开发出与专业知识和资源相关的作用 在几种人群中，艾滋病毒感染的神经行为特征 通过包括西班牙裔，黑人，妇女和IV吸毒者在内的亚组 NIMH赞助的HIV临床和行为研究中心。 提出了核心药理学实验室，该实验室将基于 哥伦比亚设施在大型多中心试验中经历了 以及创新的方法论发展。 发展研究 建议与主要临床问题密切相关，并基于 目前在每个领域的强大研究工作：发展病毒学 将专注于HIV逆转录酶的分子发病机理 对二乙氧基核苷的抗性；发育免疫学将评估 体外免疫功能测定作为替代标记 抗逆转录病毒药物疗效；发育药理学将检查 细胞内感染的细胞药理学和疗法 在艾滋病中，尤其是结核分枝杆菌；和发展 内分泌学将评估内分泌因素在 艾滋病毒浪费综合症。