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

描述(申请人提供)：赞比亚有1020万人口，是世界上最贫穷和受艾滋病毒影响最严重的国家之一。位于伯明翰的阿拉巴马大学附属赞比亚传染病研究中心(CIDRZ)是赞比亚政府应对艾滋病毒流行病的重要合作伙伴，其途径是：(1)与当地相关的预防和治疗研究；(2)向公共部门提供重大支持，以提供预防母婴艾滋病毒传播和艾滋病毒治疗服务；(3)通过培训和教育，持续投资于发展当地进行研究和服务公共卫生的能力。在这项申请中，我们建议成立一个艾滋病毒/艾滋病临床试验单位(CTU)，由卢萨卡的6个临床研究地点(CRSS)组成。其中五个CRSS将设在卢萨卡区的初级医疗设施内；所有五个都在进行由DAIDS赞助的预防、杀微生物剂或治疗的临床试验。第六个地点将位于赞比亚最有前途的科学家所在的大学教学医院，也是赞比亚唯一的医学院。在卢萨卡全境和每个拟议的CRSS，CIDRZ支持的项目目前正在为预防母婴传播和抗逆转录病毒治疗(ART)提供免费服务。在NIAID和其他机构的支持下，UAB已经在每个CRS创建了大量的临床研究空间，这些空间将专门用于CTU活动。我们建议加入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“首选附属网站”。在这些网络所代表的每个科学领域，我们都有以已完成试验(HPTN 024)和正在进行的试验(HPTN 055,039,035；ACTG 5208)的形式开展由DAIDS赞助的临床试验的经验。我们很高兴地报告，IMPAACT网络在对潜在的CTU进行竞争性审查后，将CIDRZ列为其领导层申请的第一附属网站。在上一个DAIDS供资周期中，CIDRZ专注于通过基础设施投资和培训HPTN内的运营人员来发展开展多中心研究的当地能力。在第二个资金周期中，我们的目标是通过发展赞比亚健全的科学领导，在我们良好的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作为当地网络领导人，带头加入我们的4个网络领导小组。这些当地的PI将与UAB和Vanderbilt的资深科学家配对，以帮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和实施艾滋病毒预防和治疗战略，通过真正的赞比亚-美国合作，使赞比亚人民的艾滋病毒疾病负担大大减少。这份CTU申请就是为了追求这一目标而提交的。 管理组件：

DESCRIPTION (provided by applicant): 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. ADMINISTRATIVE COMPONENT: