ADULT AIDS CLINICAL TRIALS UNIT

西奈山/贝斯以色列成人艾滋病临床试验中心(ACTU) 正在申请竞争性更新其多家医院 艾滋病临床试验小组(ACTG)成员 计划自1987年起实施。我们的部队在这方面表现出了领导力 能够生成协议并促进多学科合作 科学议程，招募不同的艾滋病毒患者群体 感染，协调数据和样本收集，执行 病毒学和免疫学评价以及药代动力学 研究、收集和报告高质量的临床和实验室 数据，并与NIAID和其他参与 成人和儿科试验。这个单位已经招收了1000多人 患者使用了60多种不同的方案，并一直在 在招收女性、少数民族和 静脉注射吸毒者。基于ACTG全国范围内的数据 数据库截至1994年12月16日，我单位招生第一 有静脉注射吸毒史的患者，在 拉美裔，在女性入学总人数中排名第三，在 全国所有Actus的黑人招生人数。我们 在纽约州的每个类别中都是第一名，除了 女人。 通过将临床试验的访问与 获得临床护理，尽管我们的总预算有所减少 要求，我们建议：(1)增加和保留至少75个新的 每年在不同的多中心新疗法试验中的患者 人类免疫缺陷病毒1型(HIV-1)感染和 相关的机会性感染和恶性肿瘤。这些研究 将在一些艾滋病患者最多的医院进行 在该国的流行地区，并可以提供试验机会 大量艾滋病毒感染者来自已经被 传统上在艾滋病试验中的代表性不足。 通过利用我们的调查力量 多学科研究团队，从内部和外部招聘 我们的机构，我们还建议：(2)为设计做出贡献 并进行将探索HIV-1致病机理的试验 感染和进一步ACTG科学委员会的研究议程 委员会。

The Mount Sinai/Beth Israel Adult AIDS Clinical Trials Unit (ACTU) is applying for competitive renewal of its multi-hospital consortium, a member of the AIDS Clinical Trials Group (ACTG) program since 1987. Our unit has demonstrated leadership in its ability to generate protocols and contribute to a multidisciplinary scientific agenda, to recruit a diverse patient population with HIV infection, coordinate data and specimen collection, perform virologic and immunologic evaluations as well as pharmacokinetic studies, collect and report high quality clinical and laboratory data, and collaborate with NIAID and other institutions involved in adult and pediatric trials. This unit has enrolled more than 1,000 patients on over 60 different protocols, and has consistently been among the leaders in enrollment of women, minorities, and intravenous drug users. Based on data in the ACTG nationwide database as of 12/16/94, our unit was first in enrollment of patients with a history of IV drug use, second in the number of Hispanics, third in total number of women enrolled, and fourth in the number of Blacks enrolled of all ACTUs across the country. We were first in each of these categories in New York State, except women. By integrating and coordinating access to clinical trials with access to clinical care, despite a decrease in our total budget request, we propose: (1) to accrue and retain a minimum of 75 new patients per year in diverse multicenter trials of new treatments for human immunodeficiency virus type 1 (HIV-1) infection and the associated opportunistic infections and malignancies. The studies will be conducted at hospitals which serve some of the highest AIDS prevalence areas in the country and can offer access to trials to large numbers of HIV-infected persons from groups which have been traditionally underrepresented in AIDS trials. By capitalizing on the investigative strengths of our multidisciplinary research team, recruited from within and outside our institutions, we also propose: (2) to contribute to the design and conduct of trials that will explore the pathogenesis of HIV-1 infection and further the research agendas of the ACTG Scientific Committees.