Centre for Infectious Diseases Research in Zambia HIV/AIDS Clinical Trials Unit

赞比亚传染病研究中心艾滋病毒/艾滋病临床试验单位

• 批准号: 8197844
• 负责人: JEFFREY Samuel Allen STRINGER
• 金额: $ 156.88万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-10 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8197844
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Affect; Alabama; American; Area; Child; Clinical; Clinical Research; Clinical Trials; Clinical Trials Unit; Collaborations; Development; Epidemic; Funding; Government; HIV; Health care facility; Home environment; IMPAACT; Infectious Diseases Research; Investments; Laboratories; Leadership; Mothers; National Institute of Allergy and Infectious Disease; Persons; Population; Prevention; Prevention strategy; Primary Health Care; Public Health; Public Sector; Reporting; Research; Research Infrastructure; Role; Scientist; Services; Site; Teaching Hospitals; Training; Training and Education; Universities; Zambia; antiretroviral therapy; burden of illness; clinical research site; experience; medical schools; microbicide; operation; prevention service; programs; response; sound; success; transmission process; treatment strategy

Zambia's population of 10.2 million persons is among the world's poorest and most severely affected by HIV. The University of Alabama at Birmingham-affiliated Centre for Infectious Disease Research in Zambia (CIDRZ) is a key partner to the Zambian government in its response to the HIV epidemic through our (1) locally-relevant prevention and treatment research, (2) major support to the public sector for provision of prevention of mother-to-child HIV transmission (PMTCT) and HIV treatment services, and (3) sustained investment, through training and education, in development of local capacity to perform research and serve the public health. In this application, we propose an HIV/AIDS Clinical Trials Unit (CTU) comprising 6 Clinical Research Sites (CRSs) in Lusaka. Five of these CRSs will be co-located within primary healthcare facilities of the Lusaka District; all five have ongoing DAIDS-sponsored clinical trials in prevention, microbicides, or treatment. The 6th site will be located at the University Teaching Hospital, home to Zambia's most promising scientists and its only medical school. Throughout Lusaka, and at each of the proposed CRSs, CIDRZ supported programs are currently providing free services for PMTCT and antiretroviral therapy (ART). UAB, with support from NIAID and others, has created substantial clinical research space at each CRS that will be dedicated to CTU activities. We are proposing affiliation with 4 network leadership groups: ACTG, IMPAACT, HPTN, and MTN. Each of these networks has listed CIDRZ in its leadership group application as a "preferred affiliated site." We have experience with DAIDS-sponsored clinical trials in each of the scientific areas represented by these networks in the form of completed (HPTN 024) and ongoing trials (HPTN 055, 039, 035; ACTG 5208.) We are pleased to report that the IMPAACT network ranked CIDRZ as its #1 affiliated site in its leadership group application after a competitive review of potential applicant CTUs. In the previous DAIDS funding cycle, CIDRZ focused on developing local capacity to conduct multi-center research through infrastructure investment and training of operations staff within the HPTN. In this second funding cycle, we aim to build upon our successes in Good Clinical and Laboratory Practice by developing sound Zambian scientific leadership. Toward that end, we propose a Zambian scientist as local network leader to spearhead our affiliation with each of the 4 network leadership groups. These local PIs will be paired with senior UAB and Vanderbilt scientists to assist them in their leadership role and nurture their professional development. Our long-term objective is to discover and implement HIV prevention and treatment strategies that will bring meaningful reductions in the HIV disease burden to the people of Zambia through a genuine Zambian-American collaboration. This CTU application is submitted in pursuit of this objective.

赞比亚有 1,020 万人口，是世界上最贫穷和受艾滋病毒影响最严重的国家之一。阿拉巴马大学伯明翰分校附属赞比亚传染病研究中心 (CIDRZ) 是赞比亚政府通过 (1) 当地相关预防和治疗研究、(2) 主要合作伙伴应对艾滋病毒流行的重要合作伙伴。支持公共部门提供预防艾滋病毒母婴传播（PMTCT）和艾滋病毒治疗服务，以及（3）通过培训和教育持续投资，发展当地开展研究和服务的能力公共卫生。在此申请中，我们提议在卢萨卡建立一个由 6 个临床研究中心 (CRS) 组成的 HIV/艾滋病临床试验单位 (CTU)。其中五个 CRS 将位于卢萨卡区的初级医疗机构内；所有五个项目均正在进行由 DAIDS 赞助的预防、杀菌剂或治疗方面的临床试验。第六个站点将位于大学教学医院，这里是赞比亚最有前途的科学家的所在地，也是赞比亚​​唯一的医学院。在整个卢萨卡以及每个拟议的 CRS 中，CIDRZ 支持的项目目前正在为 PMTCT 和抗逆转录病毒治疗 (ART) 提供免费服务。 UAB 在 NIAID 和其他机构的支持下，在每个 CRS 中创建了大量临床研究空间，专门用于 CTU 活动。我们提议加入 4 个网络领导小组：ACTG、IMPAACT、HPTN 和 MTN。这些网络中的每一个都在其领导小组申请中将 CIDRZ 列为“首选附属站点”。我们在这些网络代表的每个科学领域都有 DAIDS 赞助的临床试验经验，包括已完成的试验 (HPTN 024) 和正在进行的试验 (HPTN 055、039、035；ACTG 5208)。我们很高兴地报告，经过对潜在申请者 CTU 的竞争性审查后，IMPAACT 网络将 CIDRZ 列为其领导小组申请中排名第一的附属网站。 在上一个 DAIDS 资助周期中，CIDRZ 重点关注通过 HPTN 内的基础设施投资和运营人员培训来发展当地开展多中心研究的能力。在第二个资助周期中，我们的目标是通过发展赞比亚良好的科学领导力，在良好临床和实验室实践方面取得成功。为此，我们提议一名赞比亚科学家担任当地网络领导者，以带头领导我们与 4 个网络领导小组的联系。这些当地 PI 将与 UAB 和范德堡大学的高级科学家配对，协助他们发挥领导作用并培养他们的专业发展。我们的长期目标是发现并实施艾滋病毒预防和治疗战略，通过真正的赞比亚与美国合作，切实减轻赞比亚人民的艾滋病毒疾病负担。本 CTU 申请是为了实现这一目标而提交的。