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。亚拉巴马大学伯明翰分校附属赞比亚传染病研究中心（CIDRZ）是赞比亚政府通过我们（1）当地相关的预防和治疗研究应对艾滋病毒流行病的关键合作伙伴，（2）主要支持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，以及（3）持续投资，通过培训和教育，发展当地开展研究和为公共卫生服务的能力。在这项申请中，我们提议在卢萨卡设立一个艾滋病毒/艾滋病临床试验股，由6个临床研究中心组成。其中五个社区服务中心将设在卢萨卡区的初级保健设施内;所有五个中心都在进行由艾滋病防治司赞助的预防、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。在整个卢萨卡和每个拟议的社区康复服务中心，CIDRZ支持的方案目前正在提供预防母婴传播和抗逆转录病毒治疗的免费服务。UAB在NIAID和其他机构的支持下，在每个CRS都创造了大量的临床研究空间，专门用于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“首选附属网站”。“我们在这些网络所代表的每个科学领域都有DAIDS赞助的临床试验的经验，这些临床试验以已完成（HPTN 024）和正在进行的试验（HPTN 055，039，035; ACTG 5208）的形式进行。我们很高兴地报告，IMPAACT网络在对潜在申请人CTU进行竞争性审查后，将CIDRZ列为其领导小组申请中的第一附属网站。 在上一个DAIDS资助周期中，CIDRZ侧重于通过基础设施投资和HPTN内业务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，我们的目标是通过发展健全的赞比亚科学领导力，在良好临床和实验室规范方面取得成功。为此，我们提议由一名赞比亚科学家担任当地网络领导人，领导我们与4个网络领导小组的联系。这些本地PI将与UAB和范德比尔特的高级科学家配对，以协助他们发挥领导作用，并培养他们的专业发展。我们的长期目标是通过赞比亚-美国的真正合作，发现和执行艾滋病毒预防和治疗战略，从而切实减轻赞比亚人民的艾滋病毒疾病负担。这份反恐组的申请就是为了实现这一目标而提交的。