HIV Clinical Trials Site Planning in Northern Tanzania

坦桑尼亚北部艾滋病毒临床试验场地规划

• 批准号: 6666664
• 负责人: JOHN F SHAO
• 金额: $ 5.4万
• 依托单位: KILIMANJARO CHRISTIAN MEDICAL COLLEGE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6666664
• 关键词: AIDS; AIDS therapy; Africa; African; HIV infections; clinical research; clinical trials; comorbidity; experimental designs; health care service planning; human subject; international cooperation; opportunistic infections; training

DESCRIPTION: In response to the growing HIV epidemic in Northern Tanzania and recognizing the critical need for clinical research to address best uses of antiretrovirals and appropriate management strategies for comorbidities, we seek to develop an HIV clinical trials research unit and prepare for the submission of a CIPRA U01 grant in two years. The specific aims of this proposal are: (1) to further define characteristics of target populations for eventual antiretroviral therapy trials; (2) to formalize a collaborative HIV treatment and prevention consortium in the Kilimanjaro region and explore multi-site collaborations with HIV-investigators elsewhere in Tanzania and internationally; and (3) to train Tanzanian investigators for clinical trials design and monitoring. Each objective will be coordinated with the others so that as preliminary data are generated, research plans and collaborations will be formulated, and key young Tanzanian investigators will be trained. As this planning project progresses, individual projects and project leaders will be identified for development in the U01 application. The particular strengths of this effort include the scientific and administrative leadership of Professor John Shao at Kilimanjaro Christian Medical Centre (KCMC), a sustained track record of collegial and productive scientific collaborations with multiple international investigators, the capacity to develop infrastructure at KCMC, and a strong collaborative relationship with investigators at Duke University who have purposed to assist us in developing such a program, and in particular, in training young investigators. This proposal is further enhanced by strong complementary affiliations among KCMC and two other organizations in the Kilimanjaro Region --KIWAKKUKI, a community-based organization that provides home-based care to persons living with HIV/AIDS and is a leader in preventive efforts in the region and Kibongoto National Tuberculosis Hospital, a referral facility in which 35% of tuberculosis patients are co-infected with HIV and which has a long history of expertise in clinical trials with anti-tuberculosis regimens. This application demonstrates the extraordinary commitment and expertise already in place to expand existing infrastructure and to establish a comprehensive, multidisciplinary research program that will focus on HIV-related clinical trials, while complementing and expanding prevention efforts in our region.

描述：为了应对坦桑尼亚北部日益增长的艾滋病毒流行，并认识到临床研究的迫切需要，以解决抗逆转录病毒药物的最佳使用和合并症的适当管理策略，我们寻求建立一个艾滋病毒临床试验研究单位，并准备在两年内提交CIPRA U01拨款。该提案的具体目的是：(1)进一步确定最终抗逆转录病毒治疗试验的目标人群的特征；(2)在乞力马扎罗山地区正式建立一个艾滋病治疗和预防合作联盟，并探索与坦桑尼亚其他地方和国际艾滋病研究人员的多地点合作；(3)培训坦桑尼亚研究人员进行临床试验设计和监测。每个目标将与其他目标协调，以便在产生初步数据后，制定研究计划和合作，并培训坦桑尼亚关键的年轻调查人员。随着该计划项目的进展，将在U01应用程序中确定单个项目和项目负责人进行开发。这项工作的特别优势包括：乞力马扎罗山基督教医学中心（KCMC）的John Shao教授在科学和行政方面的领导，与多名国际研究人员的持续的大学和富有成效的科学合作记录，KCMC开发基础设施的能力，以及与杜克大学研究人员的牢固合作关系，他们旨在帮助我们开发这样一个项目，特别是，培训年轻的调查人员。KCMC与乞力马扎罗州的另外两个组织——KIWAKKUKI（一个为艾滋病毒/艾滋病感染者提供家庭护理的社区组织，是该地区预防工作的领导者）和Kibongoto国立结核病医院——之间强有力的互补关系进一步加强了这一建议。一个转诊机构，其中35%的结核病患者合并感染艾滋病毒，在抗结核方案临床试验方面具有悠久的专业经验。这一申请表明，在扩大现有基础设施和建立一个全面的、多学科的研究项目方面，已经有了非凡的承诺和专业知识，该项目将重点放在与艾滋病毒相关的临床试验上，同时补充和扩大我们地区的预防工作。