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

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。阿拉巴马大学伯明翰分校附属的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的一个重要合作伙伴，通过我们的(1)与当地相关的预防和治疗研究，(2)为公共部门提供预防母婴艾滋病毒传播（PMTCT）和艾滋病毒治疗服务的主要支持，以及(3)通过培训和教育进行持续投资。发展当地开展研究和服务公共卫生的能力。在这个申请中，我们建议在卢萨卡建立一个由6个临床研究站点（CRSs）组成的艾滋病毒/艾滋病临床试验单元（CTU）。其中5个急救中心将设在卢萨卡区的初级保健设施内；这五个国家正在进行艾滋病基金会资助的预防、杀微生物剂或治疗方面的临床试验。第六个地点将设在大学教学医院，这里是赞比亚最有前途的科学家和唯一的医学院的所在地。在整个卢萨卡和每一个拟议的crs， CIDRZ支持的项目目前正在提供预防母婴传播和抗逆转录病毒治疗（ART）的免费服务。UAB在NIAID和其他机构的支持下，在每个CRS创建了大量的临床研究空间，用于CTU的活动。我们建议加入4个网络领导小组：ACTG、IMPAACT、HPTN和MTN。这些网络都在其领导小组申请中将CIDRZ列为“首选附属站点”。在这些网络所代表的每个科学领域，我们都有完成（HPTN 024）和正在进行（HPTN 055, 039, 035; ACTG 5208）的daids赞助的临床试验的经验。我们很高兴地报告说，在对潜在申请ctu进行竞争性审查后，IMPAACT网络将CIDRZ列为其领导小组申请的第一附属网站。

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.