JOHNS HOPKINS ADULT AIDS CLINICAL TRIALS UNIT

约翰霍普金斯大学成人艾滋病临床试验中心

• 批准号: 6341597
• 负责人: Charles W. Flexner
• 金额: $ 153.07万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-01-01 至 2004-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6341597
• 关键词: AIDS; AIDS /HIV neuropathy; AIDS related neoplasm /cancer; AIDS therapy; HIV infections; Histoplasma; Mycobacterium avium; Mycobacterium tuberculosis; Pneumocystis pneumonia; antiAIDS agent; antiviral antibody; body composition; cardiovascular disorder; cardiovascular disorder prevention; clinical research; clinical trial phase I; cooperative study; cytomegalovirus; drug adverse effect; drug interactions; experimental designs; gender difference; glucose metabolism; hepatitis B virus group; hepatitis C virus; human immunodeficiency virus 1; human subject; human therapy evaluation; hydroxyurea; immunoregulation; immunotherapy; latent virus infection; lipid metabolism; longitudinal human study; nucleoside analog; nucleotide analog; nutrition; opportunistic infections; outcomes research; pathologic process; pharmacokinetics; prodrugs; protease inhibitor; statistics /biometry; therapy compliance

DESCRIPTION (adapted from applicant's abstract): Johns Hopkins University has had an ACTU since its inception in 1986. The Unit is administratively within the Division of Infectious Diseases as a component of the Johns Hopkins HIV Care Program, but it is configured to make maximum use of relevant institutional resources with investigators from multiple departments and divisions including Pharmacology, Neurology, Ophthalmology, Gynecology, Pathology and Internal Medicine. The Hopkins ACTU has provided leadership to the ACTG scientific agenda and has provided HIV clinical trials to Baltimore, a city that ranks ninth among metropolitan areas in AIDS rates. The performance record for the last grant cycle shows average enrollment, data performance and a rank of No. 3 in scientific contributions. Assets of this ACTU include leadership and scientific expertise in virology (B. Jackson), immunology (H. Lederman, T. Quinn, R. Bollinger), quality of life assessment (A. Wu), neurology (J. McArthur), pharmacology (C. Flexner), CMV retinitis (D. Jabs), and mycobacteriology (R. Chaisson). This unit has a subunit in the prison system, has developed an ACTG study of tuberculosis in Haiti and has high enrollment of injection drug users and African-Americans. This application proposes to continue a scientific portfolio that has depth and diversity to support the ACTG scientific agenda and a clinical trials program that includes good data performance and the enrollment of high priority participants. All current investigators will continue in their present roles as will the three advanced technology laboratories. Three new investigators, Dr. R. Siliciano (latent reservoirs of HIV), Dr. Richard Moore (HIV outcomes, cost and cost effectiveness), and Dr. David Thomas (hepatitis C co-infection) will be added. Preference will be given to protocols that reflect emphasis areas of the Hopkins ACTU, especially pharmacology, neurology, immunology, mycobacteriology, hepatitis C, long-term outcomes (quality of life and cost analyses) and simplified ART regimens (to better serve the patients). There will be emphasis on enhanced enrollment with a new peer recruiter and a new subunit to increase the catchment area.

描述（改编自申请人摘要）：约翰霍普金斯大学 自1986年成立以来一直有ACTU。 该股在行政上属于 传染病科是约翰霍普金斯艾滋病毒研究所的一个组成部分 Care Program，但它被配置为最大限度地利用 相关 机构资源，来自多个部门的调查员， 包括药理学在内的部门， 神经科，眼科， 妇科， 病理学和内科学。 霍普金斯ACTU为ACTG科学议程提供了领导， 为巴尔的摩提供了艾滋病临床试验，巴尔的摩是一个在艾滋病患者中排名第九的城市。 大都市地区的艾滋病发病率。 上一次拨款的表现记录 周期显示平均入学率，数据表现和排名第三， 科学贡献。 该ACTU的资产包括领导和 病毒学方面的科学专长（B. 杰克逊）、免疫学（H. Lederman，T. 奎因河Bollinger）、生活质量评估（A. Wu），neurology（J. 麦克阿瑟）， 药理学（C. Flexner）、CMV retinitis（D. 刺戳），以及 分枝杆菌学（R. Chaisson）。 这个小组在监狱系统里有一个小组， 在海地开展了一项关于结核病的ACTG研究， 注射吸毒者和非裔美国人的比例 本申请建议继续进行具有深度的科学投资组合 支持ACTG科学议程和临床试验 该计划包括良好的数据性能和高入学率 优先参与者。 所有现有的调查人员将继续在他们的 三个先进技术实验室也将发挥作用。 三个新 调查员R博士Siliciano（潜伏的艾滋病毒储存库），Richard摩尔博士 (HIV结果、成本和成本效益）和大卫托马斯博士（丙型肝炎 感染）。 将优先考虑以下方案： 反映重点 霍普金斯地区 ACTU，特别是药理学， 神经学、免疫学、分枝杆菌学、丙型肝炎、长期结局 （生活质量和成本分析）和简化的抗逆转录病毒疗法（以更好地 为病人服务）。 将重点放在提高入学率， 同侪招募员和一个新的子单位，以增加服务范围。