University of Pittsburgh Clinical Trials Unit

匹兹堡大学的这份申请书建议成立一个艾滋病毒/艾滋病临床试验股(PITT CTU)，由两个临床研究站点(CRS)组成，一个在匹兹堡大学，隶属于艾滋病临床试验小组(ACTG)和杀微生物剂试验网络(MTN)，另一个在乔治敦大学，与ACTG有关联。这两家电视网都选择了皮特CTU作为从属关系。 皮特CTU于1986年开始进行艾滋病毒/艾滋病临床试验，此后在I-IV阶段研究中获得了广泛的经验。在J.Mellors(PI)的领导下，皮特CTU于2000年成为由DAIDS资助的ACTG单位。乔治城大学CRS于2001年加入PIT CTU，目前仍是华盛顿特区唯一获得DAIDS赞助的治疗试验的机构。过去三年，PITT CTU一直是ACTG中表现最好的网站，在34个网站的成本效率(每加权应计成本)中排名第5，在34个网站的加权应计成本中排名第9，在数据管理方面的得分一直很高。这一强劲表现在本评估期(2004年7月至2005年6月)期间继续保持，皮特技术合作联盟在34个地点的总应计费用中排名第三，在成本效益方面排名第五，在妇女应计费用方面排名第八，在数据业绩方面排名第四。乔治敦大学和皮特大学的网站都对这一出色的表现负责。此外，PITT CTU调查人员通过制定方案、成为科学委员会成员和发表研究成果，为ACTG的科学成就做出了重要贡献。 PIT CTU针对这一应用程序的具体目标是：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艾滋病毒/艾滋病疫情严重影响的难以接触到的人群提供DAIDS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名参与者参加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、在科学和领导委员会任职以及指导病毒学和免疫学专业实验室来推进两个网络的科学议程；4)让新的研究人员参与并指导艾滋病毒/艾滋病临床研究；以及5)在这些工作中与社区合作。皮特CTU的调查人员和工作人员致力于通过翻译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，以实现减少艾滋病毒/艾滋病在全世界流行的影响的目标。

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 affliliated 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) and 9th 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 ACTG 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 minumum 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 speciality 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.