ADULT AIDS CLINICAL TRIALS UNIT

成人艾滋病临床试验单位

• 批准号: 7035476
• 负责人: MITCHELL GOLDMAN
• 金额: $ 188.14万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7035476
• 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 application's abstract): The Indiana University proposes to build upon the following in the renewal application: (1) scientific and administrative contributions. The Indiana ACTU ranks among the top 20 percent of ACTUs scientifically; (2) cost efficient accrual into AACTG trials. Indiana ranked third in cost weighed accrual; and (3) recruitment of women and minorities. The ACTU ranked second in recruitment of African- Americans and third in women. The long-term objectives of this site are to: expand scientific and administrative contributions through recruitment of additional investigators; increase accrual potential for women and minorities by expansion of the Wishard Hospital subunit; and increase the patient base by establishing a subunit at Community Hospital of Indianapolis. The first specific aim of the Indiana University ACTU is to contribute scientifically through submission of concept proposals and memberships on AACTG protocol teams and committees. Currently, Indiana investigators hold 32 positions on protocol teams. Concepts are proposed for: (a) salvage therapy for efavirenz failures; (b) evolution of anal dysplasia and the role of HPV in patients on HAART; (c) the role of gp 120 in HIV induced apoptosis of neurological cells in pathogenesis of dementia; (d) the role of GM-CSF and CD4 ligand on immunity to H. Capsulatum and HIV-1; (e) use of in vitro assays for drug interactions with protease inhibitors; and (f) the role of intestinal metabolism and bioavailability of antiretroviral drugs. The second specific aim is to expand the patient base, including women and minorities, though increased support for subunits at Wishard Hospital and Community Hospital. The work proposed in this application will be implemented through conduct of clinical trials as a member the AACTG, using an infrastructure that has been refined during 12 years as an ACTU. Specialized immunology, virology, and pharmacology laboratories will support this work.

描述(改编自申请摘要)：印第安纳大学 建议在续期申请中建立在以下基础上：(1) 科学和行政方面的贡献。印第安纳州ACTU是世界上 前20%的ACTUS科学；(2)AACTG的成本效益收益 审判。印第安纳州的成本加权应计利润排名第三；以及(3)招聘 妇女和少数民族。ACTU在招聘非洲人方面排名第二- 美国人排名第三，女性排名第三。该网站的长期目标是： 通过招聘以下人员来扩大科学和行政贡献 增加调查人员；增加妇女和少数群体的应计潜力 通过扩大Wishard医院附属单位；并增加病人基础# 在印第安纳波利斯社区医院建立一个小组。第一 印第安纳大学ACTU的具体目标是科学地做出贡献 通过提交关于AACTG议定书的概念提案和成员资格 团队和委员会。目前，印第安纳州调查人员在 礼宾小组。提出了以下概念：(A)法那韦仑的抢救疗法 失败；(B)肛门发育不良的演变和HPV在患者中的作用 (C)GP 120在HIV诱导神经细胞凋亡中的作用 在痴呆发病机制中的作用；(D)GM-CSF和CD4配体对免疫的作用 (E)使用体外药物相互作用试验 和(F)肠道新陈代谢和 抗逆转录病毒药物的生物利用度。第二个具体目标是扩大 患者基础，包括妇女和少数群体，尽管增加了对 Wishard医院和社区医院的附属单位。 本申请书中建议的工作将通过开展 临床试验作为AACTG的成员，使用已经 在担任ACTU的12年里得到了完善。专业免疫学、病毒学和 药理实验室将支持这项工作。