Cape Town Clinical Trials Unit (CT-CTU) for HIV/AIDS Prevention & Treatment

开普敦艾滋病毒/艾滋病预防临床试验中心 (CT-CTU)

• 批准号: 8416277
• 负责人: Robin Wood
• 金额: $ 193.19万
• 依托单位: UNIVERSITY OF CAPE TOWN
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2013-12-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8416277
• 关键词: AIDS prevention; AIDS/HIV problem; Adolescent; Area; Award; Caring; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Unit; Collaborations; Communities; Comorbidity; Complement; Conduct Clinical Trials; Funding; Grant; HIV; HIV Vaccine Trials Network; HIV vaccine; Infectious Disease Epidemiology; Laboratories; Leadership; Link; Location; Mentors; Office of Administrative Management; Perinatal; Phase; Prevention; Preventive Intervention; Psychiatry; Recording of previous events; Research; Research Activity; Robin bird; Site; South Africa; Structure; System; Training; United States National Institutes of Health; Universities; Vaccine Research; Wood material; antiretroviral therapy; base; clinical research site; data management; microbicide; operation; professor; vaccine development; virology

DESCRIPTION (provided by applicant): The Cape Town Clinical Trials Unit (CT-CTU) is applying to become a DAIDS Unit for HIV/AIDS Clinical Trials. The administrative unit for the CT-CTU is based in the Desmond Tutu HIV Centre (DTHC) at the University of Cape Town (UCT) under the leadership of Professor Robin Wood, one of South Africa's leading experts in HIV care and treatment. The CT-CTU also includes expertise from the Infectious Diseases Epidemiology Unit and the Departments of Virology and Psychiatry at UCT. The CT-CTU is comprised of three Clinical Research Sites (CRSs) located within 10 miles of the DTHC, each applying within a single DAIDS Network priority area. The Nyanga CRS is led by Dr. Linda-Gail Bekker and is focused on Vaccine Research and Development with special emphasis on adolescents. The Gugulethu CRS specializes in Phase II and III clinical trials of Microbicides and other HIV Prevention interventions and is led by Dr. David Coetzee. The DTHC CRS, led by Professor Wood, has a long history of successful trials of antiretroviral therapy and is focused on the optimization of clinical management including co-morbidities. Each of these sites has a strong track-record in multisite HIV clinical trials, including a staff complement already in place to initiate research activities within 6 months of the grant award and maintains active Community Advisory Boards, which drive community involvement in clinical research. These Clinical Research Sites will be supported by a centralized Administrative & Scientific Core providing technical support in administration and finance, laboratory systems, data management, and training and regulatory requirements. This core, based at the DTHC, will maximize efficiency in the set-up and conduct of clinical trials at each CRS. The operations of the CT-CTU are greatly simplified by the location of all administrative and management structures within the University of Cape Town. In addition, this application features a Mentoring Partnership application linking the Nyanga CRS with the HVTN CRS of the Perinatal HIV Research Unit in Johannesburg, South Africa. This partnership will strengthen the capacity of the Nyanga CRS to conduct Phase I, II and III HIV vaccine trials through training and technical support, building on the already strong relationships between these two centres developed through collaboration in the NIH-funded CIPRA-SA grant. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：开普敦临床试验单位（CT-CTU）正在申请成为艾滋病毒/艾滋病临床试验的DAIDS单位。反恐股的行政单位设在开普敦大学Desmond Tutu艾滋病毒中心，由南非艾滋病毒护理和治疗方面的主要专家之一Robin Wood教授领导。反恐小组还包括来自UCT传染病流行病学股以及病毒学和精神病学部门的专家。CT-CTU由位于DTHC 10英里范围内的三个临床研究中心（CRS）组成，每个中心都在一个DAIDS网络优先区域内申请。Nyanga CRS由Linda-Gail Bekker博士领导，专注于疫苗研究和开发，特别强调青少年。Gugulethu CRS专门从事杀微生物剂和其他艾滋病毒预防干预措施的II期和III期临床试验，由大卫库切博士领导。由Wood教授领导的DTHC CRS具有抗逆转录病毒治疗成功试验的悠久历史，并专注于优化临床管理，包括合并症。每个研究中心在多中心艾滋病毒临床试验方面都有良好的记录，包括已经到位的工作人员补充，以在获得赠款后6个月内启动研究活动，并保持活跃的社区咨询委员会，推动社区参与临床研究。这些临床研究中心将由一个集中的行政和科学核心提供支持，该核心在行政和财务、实验室系统、数据管理以及培训和监管要求方面提供技术支持。这个核心，在DTHC的基础上，将最大限度地提高效率，在设置和临床试验在每个CRS的进行。由于所有行政和管理结构都设在开普敦大学内，反恐股的运作大大简化。此外，该应用程序还具有一个指导伙伴关系应用程序，将Nyanga CRS与南非约翰内斯堡围产期艾滋病毒研究单位的HVTN CRS联系起来。这一伙伴关系将加强尼扬加CRS通过培训和技术支持进行第一、第二和第三阶段艾滋病毒疫苗试验的能力，建立在这两个中心之间通过NIH资助的CIPRA-SA赠款合作建立的牢固关系的基础上。 行政部门：