International Clinical Trials Unit

国际临床试验单位

• 批准号: 6845476
• 负责人: John A Bartlett
• 金额: $ 99.67万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6845476
• 关键词: AIDS; Africa; clinical research; comorbidity; cooperative study; female reproductive system; human papillomavirus; human subject; international cooperation; malaria; microorganism interaction; mycosis; patient oriented research; pediatrics; protozoal infection; reproductive system infection; training; tuberculosis; virus cytopathogenic effect

DESCRIPTION (provided by applicant): The four partners in this ISAAC Unit application, Kilimanjaro Christian Medical Centre (KCMC), Kibongoto National Tuberculosis Hospital (KNTH), KIWAKKUKI and Duke University Medical Center wish to expand their studies of AIDS-associated co-infections. Tanzania is an area with extraordinary need for HIV/AIDS-related care, and is listed among the 14 countries in the President's Emergency Plan for AIDS Relief. These partners have existing research collaborations investigating AIDS-associated co-infections that have generated the preliminary data in this application. A broad spectrum of co-infections will be studied, including MTB, malaria, bacterial and non-malarial protozoa, fungi, and human papillomavirus involving the female genital tract, reflecting the diverse research expertise of the ISAAC Unit partners. Expertise in HIV viral and immune pathogenesis will offer outstanding insights into HIV/Co-Pathogen interactions. A Pediatric Scientific Program will ensure the opportunity to study age-specific co-infections, and community participation will be solicited through the Community Relations/Education Administrative Program. During year 1 of the ISAAC Unit, our goal will focus on expanding research infrastructure through training and the purchase of key laboratory equipment. Research training will be provided through didactic presentations and site monitoring by Pharmaceutical Product Development, and twinning between U.S. and Tanzanian personnel will provide ongoing support. During years 2-4 the ISAAC Unit Scientific Programs will generate concept proposals for specific research projects, and 24 concept proposals are included with this application as examples of the research creativity and capabilities of ISAAC Unit investigators. These concept proposals will be reviewed by the Principal Investigators, and with the guidance of the ISAAC Unit Scientific Advisory Committee, select proposals will be funded. Logistic assistance to ensure the efficient conduct of ISAAC Unit research will be provided by the Administrative Programs, and the Principal Investigators will hold research projects to a timeline, leading to the publication of research results. In summary, substantial research infrastructure, experience and collaboration among the four partners is currently available. Award of an ISAAC Unit will allow these partners to dramatically expand research by providing a scientific and administrative support organization, well-trained personnel for the conduct of research, laboratory equipment and research funding.

描述（由申请人提供）：ISAAC单位申请中的四个合作伙伴，乞力马扎罗基督教医疗中心（KCMC），Kibongoto国家结核病医院（KNTH），Kiwakkuki和Duke University Medical Center希望扩大他们与艾滋病相关的共同感染的研究。坦桑尼亚是一个对与艾滋病毒/艾滋病相关的护理非常需要的地区，在总统艾滋病救济紧急计划中被列为14个国家。这些合作伙伴进行了现有的研究合作，调查了与艾滋病相关的共同感染，这些共同感染已在本应用程序中产生了初步数据。将研究各种各样的共同感染，包括MTB，疟疾，细菌和非疟疾原生动物，真菌以及涉及女性生殖道的人乳头瘤病毒，反映了以撒单位伴侣的多样化研究专家。 HIV病毒和免疫发病机理方面的专业知识将为艾滋病毒/副病原体相互作用提供出色的见解。一项小儿科学计划将确保有机会研究特定年龄的共同感染，并通过社区关系/教育行政计划征求社区参与。 在ISAAC部门的第一年中，我们的目标将集中在通过培训和购买主要实验室设备来扩展研究基础设施。研究培训将通过药物开发的教学演示和现场监控提供，美国和坦桑尼亚人员之间的双胞胎将提供持续的支持。在2 - 4年期间，ISAAC单位科学计划将为特定的研究项目生成概念建议，本应用程序中包括24个概念建议，作为ISAAC单位研究者的研究创造力和能力的示例。这些概念建议将由首席研究人员审查，并在ISAAC单位科学咨询委员会的指导下，将资助某些建议。行政计划将提供以确保艾萨克单位研究有效进行的逻辑援助，主要研究人员将向时间表持有研究项目，从而导致研究结果发布。总而言之，目前可以提供四个合作伙伴之间的大量研究基础设施，经验和协作。以撒单位的奖励将使这些合作伙伴通过提供科学和行政支持组织，训练有素的研究，实验室设备和研究资金来大大扩展研究。