Johns Hopkins University Baltimore India Clinical Trail Unit (JHUBI CTU)

JHUBI项目总结 拟议的约翰霍普金斯大学巴尔的摩-印度临床试验单位(JHUBI CTU)将结合三项 高效临床研究站点(CRSS)：约翰霍普金斯大学(JHU)JHU学院的CRS 巴尔的摩拜拉姆吉·杰杰布霍伊政府医学院-约翰·霍普金斯大学 (BJGMC-JHU)印度浦那的CRS和Y.R.盖通德艾滋病研究和教育中心(YRG) CARE)在印度金奈的CRS，致力于结束艾滋病毒、结核病和共病的流行。这些网站 包括巴尔的摩最大的艾滋病毒护理提供者，巴尔的摩最大的艾滋病毒和结核病护理和临床研究提供商 印度浦那，以及印度金奈最大的艾滋病毒预防和治疗护理及临床研究中心。 其中两个站点目前隶属于现有的NIAID网络(JHU站点201和BJGMC-JHU站点 31441)，而YRG CARE正在申请成为一个新网站，但其大部分员工和基础设施都是 以前是网络站点11701的一部分。这三个网站都有由NIH资助的广泛的、正在进行的研究 ，隶属于JHU医学院传染病学部。 巴尔的摩，这将是CTU的家。在过去的25年里，这三个网站做出了贡献 对所有现有的DAIDS赞助的研究的科学、人口和管理都有重要意义 网络：1)艾滋病临床试验小组(ACTG)；2)国际母婴青少年艾滋病 临床试验小组(IMPAACT)；3)艾滋病毒预防试验网络(HPTN)；4)杀菌剂试验 网络(MTN)；和5)艾滋病毒疫苗试验网络(HVTN)。自2013年12月以来，JHUBI CTU 调查人员领导了10个ACTG、7个IMPAACT和2个HPTN科学和行政委员会；领导了27个 ACTG、11个IMPAACT、7个HPTN和1个HVTN方案；编写了2,167个艾滋病毒、结核病、肝炎和相关疾病 科学出版物，包括150份与网络有关的出版物。此外，JHUBI CTU已经招收和 跟踪2702名参与者，90%的保留率进入ACTG、IMPAACT和HPTN试验，以及&gt；30000 参与与DAIDS网络科学未来7年相关的非网络研究。JUBI CTU 建议加入所有四个艾滋病网络：艾滋病毒成人治疗网络、青少年母亲网络和儿童网络 治疗学、艾滋病毒预防和艾滋病毒疫苗。JHUBI CTU将雇佣最高素质的人 根据我们使命宣言的执行情况进行的主题研究：“为巴尔的摩社区服务 和印度，约翰霍普金斯大学巴尔的摩-印度临床试验单位(JHUBI CTU)将开发和 提供最优先的艾滋病毒预防和治疗研究。为了支持NIAID网络， JHUBI CTU将提供科学领导，接触关键人群，以及最高效和负责任的 管理我们的临床试验活动。“

JHUBI PROJECT SUMMARY The proposed Johns Hopkins University Baltimore-India Clinical Trials Unit (JHUBI CTU) will combine three highly productive Clinical Research Sites (CRSs): the Johns Hopkins University (JHU) CRS at the JHU School of Medicine in Baltimore, the Byramji Jeejeebhoy Government Medical College-Johns Hopkins University (BJGMC-JHU) CRS in Pune, India, and the Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE) CRS in Chennai, India, committed to ending the HIV, TB and comorbidities epidemics. These sites include the largest HIV care provider in Baltimore, the largest HIV and TB care and clinical research provider in Pune, India, and the largest HIV prevention and treatment care and clinical research center in Chennai, India. Two of these sites are currently affiliated with existing NIAID Networks (JHU site 201 and BJGMC-JHU site 31441), while YRG CARE is applying as a new site but has most of its staff and infrastructure that was previously part of Network site 11701. All three of these sites have extensive, ongoing NIH-funded research portfolios, and are affiliated with the Division of Infectious Diseases at the JHU School of Medicine in Baltimore, which will serve as the CTU home. Over the past 25 years, these three sites have contributed significantly to the science, populations, and management of studies sponsored by all of the existing DAIDS Networks: 1) the AIDS Clinical Trials Group (ACTG); 2) the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT); 3) the HIV Prevention Trials Network (HPTN); 4) the Microbicides Trials Network (MTN); and 5) the HIV Vaccine Trials Network (HVTN). Since December 2013, JHUBI CTU investigators have led 10 ACTG, 7 IMPAACT, and 2 HPTN scientific and administrative committees; led 27 ACTG, 11 IMPAACT, 7 HPTN and 1 HVTN protocols; and authored 2,167 HIV, TB, hepatitis, and related scientific publications, including 150 Network-related publications. In addition, the JHUBI CTU has enrolled and followed 2,702 participants with >90% retention into ACTG, IMPAACT, and HPTN trials, and >30,000 participants into non-Network studies relevant to the next 7 years of DAIDS Network science. The JHUBI CTU proposes to affiliate with all four DAIDS Networks: HIV Adult Therapeutics, Maternal Adolescent and Pediatric Therapeutics, HIV Prevention, and HIV Vaccine. The JHUBI CTU will engage in the highest quality human subjects research based on implementation of our Mission Statement: "To serve our communities in Baltimore and India, the Johns Hopkins University Baltimore-India Clinical Trials Unit (JHUBI CTU) will develop and provide access to the highest priority HIV prevention and treatment research. To support NIAID networks, the JHUBI CTU will provide scientific leadership, access to key populations, and the most efficient and responsible management of our clinical trials activities."