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

JHUBI项目总结 拟议中的约翰霍普金斯大学巴尔的摩-印度临床试验单位（JHUBI CTU）将联合收割机结合三个 高效临床研究中心（CRS）：约翰霍普金斯大学（JHU）CRS 在巴尔的摩的医学院，Byramji Jeejeebhoy政府医学院-约翰霍普金斯大学 （BJGMC-JHU）印度浦那的CRS和Y.R. Gaitonde艾滋病研究和教育中心（YRG CARE）CRS在印度金奈，致力于结束艾滋病毒，结核病和合并症的流行。这些网站 包括巴尔的摩最大的艾滋病毒护理提供者， 印度浦那，以及印度金奈最大的艾滋病防治护理和临床研究中心。 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正在申请作为一个新的网站，但其大部分工作人员和基础设施， 11701网络的一部分。所有这三个网站都有大量的，正在进行的NIH资助的研究 投资组合，并隶属于传染病科在医学院的JHU 巴尔的摩，将作为反恐组的总部。在过去的25年里，这三个网站贡献了 对所有现有DAIDS赞助的研究的科学、人口和管理都有重大意义 网络：1）艾滋病临床试验组（ACTG）; 2）国际妇幼青少年艾滋病 临床试验组（IMPAACT）; 3）艾滋病毒预防试验网络（HPTN）; 4）杀微生物剂试验 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 研究人员领导了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项IMPAACT、7项HPTN和1项HVTN方案;并撰写了2，167份艾滋病毒、结核病、肝炎和相关疾病 科学出版物，包括150份网络相关出版物。此外，JHUBI CTU已经招募并 在ACTG、IMPAACT和HPTN试验中随访了2，702名保留率>90%的参与者， 参与者参与与未来7年的DAIDS网络科学相关的非网络研究。JHUBI CTU 建议加入所有四个DAIDS网络：艾滋病毒成人治疗，孕产妇青少年和儿科 治疗，HIV预防和HIV疫苗。JHUBI CTU将从事最高质量的人力 主题研究的基础上实施我们的使命声明：“服务于我们的社区在巴尔的摩 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 提供获得最优先的艾滋病毒预防和治疗研究的机会。为了支持NIAID网络， JHUBI CTU将提供科学的领导，接触关键人群，以及最有效和负责任的 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."