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中文摘要
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描述(由申请人提供):西雅图-洛桑-坎帕拉临床试验单位(SLK CTU)在未来七年内有一个共同的目标,即努力建立一个没有艾滋病的世界。拟议中的CTU由Fred Hutchinson癌症研究中心(FHCRC)管理,将整合目前三个高性能的CTU,并在撒哈拉以南非洲增加一个新的经验丰富的高容量CRS。SLK CTU将利用过去二、三十年来为改进艾滋病毒-1疫苗开发、预防和护理作出重大贡献的六名国际艾滋病毒-1领导人的集体不同专业知识。四个综合临床研究站点(CRSs)将处理NIAID艾滋病毒网络的四个领导议程:西雅图VMP(疫苗、杀微生物剂和预防)、西雅图UW ACTU(成人治疗)、洛桑VIC (Vaudois大学医院中心)(疫苗)和坎帕拉kasangati -传染病研究所(IDI)(预防和成人治疗)。为了实现CTU的共同目标和网络议程,临床研究和活动将针对以下四个具体目标:
英文摘要
DESCRIPTION (provided by applicant): The Seattle-Lausanne-Kampala Clinical Trials Unit (SLK CTU) shares a common goal over the next seven years to work toward a world free of AIDS. The proposed CTU, administered through Fred Hutchinson Cancer Research Center (FHCRC), will consolidate three current high-performing CTUs and add one new experienced, high-capacity CRS in sub-Saharan Africa. The SLK CTU will harness the collective diverse expertise of six international HIV-1 leaders who have made significant contributions to improve HIV-1 vaccine development, prevention and care over the past 2-3 decades. The four integrated Clinical Research Sites (CRSs) will address four NIAID HIV network leadership agendas: Seattle VMP (vaccine, microbicide, and prevention), UW ACTU in Seattle (adult therapeutic), Lausanne VIC (Centre Hospitaller Universitaire Vaudois) (vaccine), and Kasangati-lnfectious Diseases Institute (IDI) in Kampala (prevention and adult therapeutic). To accomplish the CTU's common goal and the networks' agendas, clinical research studies and activities will be directed toward the following four specific aims: Specific Aim 1: Contribute leadership and expertise to address current and new scientific priorities related to HIV-1 vaccination, prevention, microbicides and therapeutics. Specific Aim 2: Provide centralized administrative oversight through consolidation of the current infrastructure and operations of our existing CTUs and clinical trials programs, to integrate and expand the CRS activities within the four networks. Specific Aim 3: Conduct phase 1-3 clinical trials under the direction of the four NIAID- sponsored HIV networks and provide the trial support necessary to ensure the highest quality standards of clinical research. Specific Aim 4: Continue and extend partnerships with the CRS communities and stakeholders to enlist their support and guarantee successful enrollment and participation of relevant study populations that are impacted by the HIV epidemic. Our CTU recognizes the challenges moving forward. Inherent characteristics of our structure, expertise, and ability to leverage related activities in our rich environment offer innovation to the clinical trials networks.
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