AIDS CLINICAL TRIALS

艾滋病临床试验

• 批准号: 2064025
• 负责人: Margaret A Fischl
• 金额: $ 216.35万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 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/2064025
• 关键词: AIDS; AIDS therapy; HIV infections; clinical trials; cooperative study; human subject; human therapy evaluation

The Miami ACTG has successfully designed, implemented and participated in all aspects of clinical trials research through the ACTG; successfully enrolled a large number of patients in these trials, including women and minority patients; and helped develop and establish the research goals and priorities of the ACTG. The Miami ACTG will continue to actively participate in the design, implementation, conduct, analyses and presentation of ACTG clinical trials. 150 patients will be enrolled in the first year and 210-250 patients from previous yrs enrollment will be followed. It is anticipated that 10-20% of the patients enrolled will be women and 45-55% will be minority patients. Approximately 55% of the patients will be enrolled in primary infection studies, 30% in opportunistic infection studies, 14% in HIV-related malignancy studies and 1% in neurology studies. Thus, approximately 60% of the patients will be enrolled in phase III studies and 40% in phase I/II studies. This effort is supported by an internal computer tracking and information system; an internal research medical records system; a data management and on site quality assurance program; and a case management program designed to increase enrollment of women and minorities and to enhance adherence. All ambulatory ACTG clinical trials will be conducted in a new clinical research facility with an on site research pharmacy, phlebotomy suite, and reference laboratory with specimen storage capacity. The investigators have designed and participated in over 30 single or multicenter studies and have considerable expertise in HIV clinical trials. The Miami ACTG has two strong core resources, virology and immunology, which will add to its ability to evaluate virologic markers, quantitative viral assays, drug resistance, leukocyte markers and soluble factors with clinical outcome.

迈阿密ACTG已成功设计，实施和参与 通过ACTG进行临床试验研究的所有方面；成功地 在这些试验中招募了大量患者，包括妇女和 少数族裔患者；并帮助制定和建立研究目标和 ACTG的优先事项。 迈阿密的行为将继续积极 参与设计，实施，行为，分析和 ACTG临床试验的介绍。 150名患者将入学 第一年和以前入学率的210-250名患者将 紧随其后。 预计入选患者中有10-20％是 妇女和45-55％将是少数族裔患者。 大约55％ 患者将参加原发性感染研究，30％ 机会性感染研究，与HIV相关的恶性肿瘤研究中有14％ 1％的神经学研究。 因此，大约60％的患者将是 参加了第三阶段研究，在I/II期研究中有40％。 这项努力 由内部计算机跟踪和信息系统支持；一个 内部研究医疗记录系统；数据管理和现场 质量保证计划；以及旨在的案例管理计划 增加妇女和少数民族的入学率并提高依从性。 全部 门诊ACTG临床试验将在新的临床中进行 具有现场研究药房的研究设施，静脉切开术套件和 带有标本存储能力的参考实验室。 调查人员 已经设计并参与了30多个单一或多中心研究， 在HIV临床试验方面拥有丰富的专业知识。 迈阿密的ACTG有两个 强大的核心资源，病毒学和免疫学，这将增加 评估病毒学标记，定量病毒测定，药物的能力 具有临床结果的抗性，白细胞标记和可溶性因子。