ADULT AIDS CLINICAL TRIALS UNIT

描述(改编自申请人的摘要)：本申请书适用于 匹兹堡的一个新的成人艾滋病临床试验单位(AACTU)作为 成人艾滋病临床试验小组(AACTG)。匹兹堡分部加入了 AACTG于1997年1月成为凯斯西部保护区的一个子单位 大学ACTU。因为作为一个子单位的表现和对 关于委员会的科学议程，执行委员会建议 匹兹堡股将在下一个供资周期(2000-2004年)成为一个新的反恐股。 匹兹堡AACTU计划招募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 完全在该股的能力范围内，该股有十多年的经验 在感染艾滋病毒的成年人身上进行NIH和行业赞助的临床试验， 包括妇女和少数族裔。 在匹兹堡建立AACTU将允许几种艾滋病毒 匹兹堡大学的研究人员为科学研究做出贡献 ACTG的议程。在首席调查员约翰的领导下 W.Mellors，M.D.，匹兹堡分部的研究计划将集中在 AACTG科学议程的下列领域：(1)艾滋病毒-- 有效的“抢救/挽救”疗法的确定和艾滋病毒的评价 抗药性检测；(2)感染性并发症--治疗和 预防机会性感染；(3)免疫学/基于免疫的治疗 -免疫重建机制和治疗性疫苗；(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)神经并发症- 中枢神经系统HIV感染的神经发病机制及治疗效果 纵向关联随机试验--预测药物的病毒学因素 失败；以及(7)药理-抗逆转录病毒药物的分布/相互作用 以及提高服药依从性的干预措施。

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.