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: 6582724
• 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/6582724
• 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.

产品说明：为了应对坦桑尼亚北方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适当的合并症管理策略，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 U 01赠款。 这项建议的具体目标是：（1）进一步确定最终进行抗逆转录病毒疗法试验的目标人群的特点;（2）在基利曼哈罗地区正式建立一个艾滋病毒治疗和预防协作联合体，并探讨与坦桑尼亚其他地方和国际上的艾滋病毒调查人员进行多地点合作;（3）培训坦桑尼亚调查人员进行临床试验设计和监测。每个目标都将与其他目标协调，以便在产生初步数据时，制定研究计划和合作，并培训坦桑尼亚的主要年轻调查人员。随着该规划项目的进展，将确定在U 01应用程序中开发的各个项目和项目负责人。这一努力的特殊优势包括基利曼哈罗基督教医学中心（KCMC）的John Shao教授的科学和行政领导，与多个国际研究人员的合议和富有成效的科学合作的持续记录，在KCMC开发基础设施的能力，以及与杜克大学的研究人员的强有力的合作关系，他们旨在帮助我们开发这样一个项目，特别是培养年轻的调查人员。KCMC与基利曼哈罗地区的另外两个组织-KIWAKKUKI，一个向艾滋病毒/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，以及Kibongoto国家结核病医院，一个转诊机构，其中35%的结核病患者同时感染艾滋病毒，并且在抗结核治疗方案的临床试验方面具有悠久的专业历史。这一申请表明了已经到位的非凡承诺和专业知识，以扩大现有的基础设施，并建立一个全面的，多学科的研究计划，将重点放在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。