HIV Clinical Trials Site Planning in Northern Tanzania

描述：为了应对坦桑尼亚北部日益严重的艾滋病毒流行，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战略，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赠款。这项建议的具体目标是：(1)进一步确定最终抗逆转录病毒治疗试验的目标人群特征；(2)在乞力马扎罗地区正式建立艾滋病毒治疗和预防合作联盟，并探索与坦桑尼亚其他地区和国际上的艾滋病毒研究人员进行多地点合作；以及(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相协调，以便在产生初步数据时，将制定研究计划和合作，并培训坦桑尼亚主要的年轻调查人员。随着规划项目的进展，将在U01应用程序中确定要开发的单个项目和项目负责人。这一努力的特别优势包括乞力马扎罗基督教医学中心(KCMC)的John Shao教授在科学和行政方面的领导能力、与多名国际研究人员开展富有成效的科学合作的持续记录、KCMC发展基础设施的能力以及与杜克大学研究人员的密切合作关系，后者旨在帮助我们制定这样的计划，特别是在培训年轻研究人员方面。KCMC和乞力马扎罗地区的另外两个组织--KIWAKKUKI--一个为艾滋病毒/艾滋病患者提供家庭护理的社区组织，是该地区预防工作的领导者，以及基本戈托国立结核病医院--一个转介机构，35%的结核病患者同时感染艾滋病毒，在抗结核方案的临床试验方面拥有长期的专业知识，这进一步加强了这项建议。这项申请表明了我们在扩大现有基础设施和建立全面的多学科研究计划方面已经做出的非凡承诺和专业知识，该计划将专注于与艾滋病毒相关的临床试验，同时补充和扩大我们地区的预防工作。

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.