ADULT AIDS CLINICAL TRIALS UNIT

成人艾滋病临床试验单位

• 批准号: 6702265
• 负责人: John W Mellors
• 金额: $ 158.81万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6702265
• 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 the applicant's abstract): This application is for a new Adult AIDS Clinical Trials Unit (AACTU) in Pittsburgh as part of the Adult AIDS Clinical Trials Group (AACTG). The Pittsburgh Unit joined the AACTG in January 1997, by becoming a subunit of the Case Western Reserve University AACTU. Because of performance as a subunit and contributions to the scientific agenda of the AACTG, the Executive Committee recommended that the Pittsburgh Unit become a new AACTU in the next funding cycle (2000-2004). The Pittsburgh AACTU plans to enroll 360 patients into AACTG trials between 2000-2004 (60 patients year 1; 75 patients per year for years 2-5). This is well within the capacity of the Unit, which has over ten years of experience conducting NIH- and industry sponsored clinical trials in HIV-infected adults, including women and minorities. The establishment of an AACTU in Pittsburgh will permit several HIV researchers at the University of Pittsburgh to contribute to the scientific agenda of the AACTG. Under the leadership of the Principal Investigator, John W. Mellors, M.D., the research plan of the Pittsburgh Unit will concentrate on the following areas of the AACTG scientific agenda: (1) HIV Disease - identification of effective "rescue/salvage" therapies and evaluation of HIV drug resistance testing; (2) Infectious Complications - treatment and prophylaxis of opportunistic infections; (3) Immunology/immune-based Therapies - mechanisms of immune reconstitution and therapeutic vaccines; (4) Metabolic Complications - the effects of antiretroviral therapy on glucose metabolism, insulin sensitivity and body composition; (5) Neurologic Complications - neuropathogenesis of CNS HIV infection and the effects of treatment; (6) Longitudinal Linked Randomized Trials - virologic factors that predict drug failure; and (7) Pharmacology - distribution/interaction of antiretrovirals and interventions to enhance medication adherence.

描述（改编自申请人的摘要）：本申请适用于 作为匹兹堡新的成人艾滋病临床试验中心 (AACTU) 的一部分 成人艾滋病临床试验组 (AACTG)。 匹兹堡单位加入 1997 年 1 月，AACTG 成为凯斯西储的一个子单位 大学 AACTU。 由于作为子单位的表现和贡献 AACTG 的科学议程，执行委员会建议 匹兹堡单位在下一个资助周期（2000-2004）成为一个新的 AACTU。 匹兹堡 AACTU 计划在 2017 年期间招募 360 名患者参加 AACTG 试验 2000-2004 年（第 1 年 60 名患者；第 2-5 年每年 75 名患者）。 这是 完全符合该单位的能力范围，该单位拥有十多年的经验 对感染艾滋病毒的成年人进行 NIH 和行业赞助的临床试验， 包括妇女和少数民族。 匹兹堡 AACTU 的建立将允许若干艾滋病毒 匹兹堡大学的研究人员为科学做出贡献 AACTG 的议程。 在首席研究员约翰的带领下 W. Mellors，医学博士，匹兹堡中心的研究计划将集中于 AACTG 科学议程的以下领域： (1) HIV 疾病 - 确定有效的“救援/抢救”疗法并评估艾滋病毒 耐药性检测； (2) 感染性并发症——治疗和 预防机会性感染； (3) 免疫学/免疫疗法 - 免疫重建和治疗性疫苗的机制； (4) 新陈代谢 并发症 - 抗逆转录病毒治疗对葡萄糖代谢的影响， 胰岛素敏感性和身体成分； (5) 神经系统并发症 - 中枢神经系统HIV感染的神经发病机制及治疗效果； (6) 纵向连锁随机试验 - 预测药物的病毒学因素 失败; (7) 药理学 - 抗逆转录病毒药物的分布/相互作用 以及提高药物依从性的干预措施。