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: 6021497
• 负责人: JOHN G BARTLETT
• 金额: $ 130.45万
• 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/6021497
• 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(改编自申请者摘要)：约翰霍普金斯大学 自1986年成立以来一直是ACTU的成员。该股在行政上属于 作为约翰·霍普金斯大学艾滋病毒组成部分的传染病部门 关怀计划，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人员和 包括药理学、神经病学、眼科、妇科、 病理学和内科。 霍普金斯ACTU为ACTG的科学议程提供了领导，并 向巴尔的摩提供艾滋病毒临床试验，巴尔的摩在 大都市地区的艾滋病发病率。最后一次拨款的绩效记录 周期显示平均招生人数、数据表现和排名第三 科学贡献。这个ACTU的资产包括领导力和 病毒学(B.Jackson)、免疫学(H.Lederman，T. 生活质量评估(A.Wu)，神经病学(J. McArthur)、药理学(C.Flexner)、CMV视网膜炎(D.jabs)和 分枝杆菌细菌学(R.Chaisson)。这个单位在监狱系统中有一个亚单位， 已经制定了一项关于海地结核病的ACTG研究，并有很高的入学率 注射吸毒者和非裔美国人。 这个应用程序建议继续一个有深度的科学文件夹 和多样性，以支持ACTG科学议程和临床试验 该计划包括良好的数据性能和高的招生 优先参与者。所有现任调查人员将继续他们的 三个先进技术实验室将发挥作用。三个新的 调查人员，R.Siliciano博士(艾滋病毒潜伏宿主)，Richard Moore博士 (艾滋病毒结果、成本和成本效益)和David Thomas博士(丙型肝炎 共同感染)将被添加。优先考虑符合以下条件的协议 反映霍普金斯ACTU的重点领域，特别是药理学， 神经学、免疫学、分枝杆菌学、丙型肝炎、长期疗效 (生活质量和成本分析)和简化的抗逆转录病毒治疗方案(为了更好地 为病人服务)。将重点放在通过一个新的 同行招募者和一个新的子单位，以增加集水区。