University of Pittsburgh Clinical Trials Unit

描述（由申请人提供）：这份来自匹兹堡大学的申请提出了一个艾滋病毒/艾滋病临床试验单位（皮特CTU），由两个临床研究地点（CRS）组成，一个在匹兹堡大学，隶属于艾滋病临床试验组（ACTG）和杀微生物剂试验网络（MTN），一个在乔治城大学，隶属于ACTG。两个电视网都选择了皮特CTU作为联盟。皮特CTU于1986年开始进行艾滋病毒/艾滋病临床试验，并在I-IV期研究中获得了广泛的经验。在j·梅勒斯（PI）的领导下，皮特CTU于2000年成为艾滋病规划署资助的ACTG单位。乔治城大学的CRS于2001年加入皮特CTU，并且仍然是唯一一个在华盛顿特区获得艾滋病赞助治疗试验的机构。皮特CTU在过去三年中一直是ACTG中表现最好的网站，在34个网站的成本效率（加权应计成本）中排名第五，在34个网站的加权应计成本中排名第九，在数据管理方面一直表现出色。在目前的评估期间（2004年7月至2005年6月），这种强劲的表现仍在继续，皮特CTU在34个地点中排名第三，在成本效率方面排名第五，在妇女方面排名第八，在数据表现方面排名第四。乔治敦大学和皮特大学都对这一优异的成绩负有责任。此外，皮特CTU的研究人员通过制定协议、加入科学委员会和发表研究成果，为ACT G的科学成就做出了重要贡献。皮特CTU的具体目标是：1)为华盛顿特区以及宾夕法尼亚州西部和西弗吉尼亚州的农村和城市地区受到艾滋病毒/艾滋病流行严重影响的难以接触的人群提供艾滋病赞助的临床试验，这些地区没有其他途径；2)在项目期间招募、筛选和招募至少420名参与者，参与涉及转化研究和药物开发、优化临床管理、治疗性疫苗研发和杀微生物剂等优先领域的试验；3)通过制定研究方案、在科学委员会和领导委员会任职以及指导病毒学和免疫学专业实验室，推进两个网络的科学议程；4)让新的研究者参与并指导艾滋病临床研究；5)在这些努力中与社区合作。皮特CTU的研究人员和工作人员致力于通过转化研究，确定治疗和预防艾滋病毒-1感染及其并发症的最佳战略，减少全球艾滋病毒/艾滋病流行病的影响。

DESCRIPTION (provided by applicant): This application from the University of Pittsburgh proposes an HIV/AIDS Clinical Trials Unit (Pitt CTU)consisting of two Clinical Research Sites (CRS), one at the University of Pittsburgh affiliated with the AIDS Clinical Trials Group (ACTG) and the Microbicide Trials Network (MTN), and one at Georgetown University affiliated with the ACTG. Both Networks have selected the Pitt CTU for affiliation. The Pitt CTU began conducting HIV/AIDS clinical trials in 1986 and has since acquired broad experience in Phase I-IV studies. Under the leadership of J. Mellors (PI), the Pitt CTU became a DAIDS-funded ACTG Unit in 2000. The Georgetown University CRS joined the Pitt CTU in 2001 and remains the only access to DAIDS-sponsored treatment trials in Washington, DC. The Pitt CTU has been a top performing site in the ACTG over the past three years, ranking 5th out of 34 sites in cost efficiency (cost per weighted accrual) and9th of 34 sites in weighted accrual, with consistently outstanding scores for data management. This strong performance has continued during the current evaluation period (July 2004 - June 2005), with the Pitt CTU ranking 3rd of 34 sites in total accrual, 5th in cost efficiency, 8th in accrual of women, and 4th in data performance. Both the Georgetown and Pitt sites are responsible for this excellent performance. In addition, Pitt CTU investigators have made important contributions to the scientific accomplishments of the ACT G through protocol development, membership on scientific committees, and publication of research findings. The specific aims of the Pitt CTU for this application are: 1) to provide access to DAIDS-sponsored clinical trials for difficult-to-reach populations heavily impacted by the HIV/AIDS epidemic in Washington, DC, and in rural and urban areas of western Pennsylvania and West Virginia, where no other access exists; 2) to recruit, screen, and enroll a minimum of 420 participants during the project period in trials addressing the priority areas of translational research and drug development, optimization of clinical management, therapeutic vaccine research and development, and microbicides; 3) to advance the scientific agenda of both Networks by developing research protocols, serving on scientific and leadership committees, and directing virology and immunology specialty laboratories; 4) to involve and mentor new investigators in HIV/AIDS clinical research; and 5) to partner with the community throughout these endeavors. The investigators and staff of the Pitt CTU are committed to the goal of reducing the impact of the HIV/AIDS epidemic worldwide through translational research to define optimal strategies for treatment and prevention of HIV-1 infection and its complications. ADMINISTRATIVE COMPONENT: