Byramee Jeejeebhoy Medical College (BJMC), Pune, India: Clinical Trials Unit

描述(由申请人提供)： 印度浦那Byramjee Jeejeebhoy医学院(BJMC)的印度-美国合作研究小组目前正在进行印度唯一由NIH赞助的预防母婴传播艾滋病毒(MTCT)的第三阶段随机临床试验。为了回应这一RFA，我们建议成立一个拥有单一临床研究站点(CRS)的临床试验单位(CTU)，该单位将建立在我们现有的领导、组织、临床试验管理程序以及我们经验丰富的研究人员和员工的成功基础上。我们的CTU提议参与将涉及两个研究优先领域的试验：1)预防母婴传播和2)优化艾滋病毒感染儿童的临床管理。约翰霍普金斯大学(JHU)将是主要受赠人，并将通过两个分包合同(BJMC和ED Search)支持反恐联盟的领导、行政、社区活动和浦那的一个社区研究中心。BJMC将为CTU提供科学和行政领导，并为CRS提供临床/实验室基础设施和临床护理支持。BJMC还将利用国家艾滋病研究所的帮助，提供专门的实验室支持。ED Search是一家注册的印度非营利性信托公司，将提供科学和行政领导，以及CRS的日常管理、监管要求和良好的临床实践。Ed Search还将管理对我们的社区咨询委员会的支持，以及我们在浦那市政公司和Pimpri Chinchwad市政公司运营的21个社区诊所的试招计划。我们的申请反映了一个功能齐全、经验丰富、积极招募的CTU，它拥有三年多在印度进行唯一的第三阶段艾滋病毒预防临床试验的经验。我们还拥有重要的基础设施，经过验证的GCP跟踪记录，以及登记和保留母亲和婴儿的能力。自2003年8月以来，我们的CRS已经为浦那54,000多名孕妇提供了艾滋病毒自愿咨询和检测。在我们目前的母婴传播试验中，我们招募了593名艾滋病毒感染母亲(每月20人)。我们的儿科治疗试验能力得到了我们对160名艾滋病毒感染儿童的积极跟踪和基于社区的支持性转诊计划的支持。全球艾滋病毒流行的轨迹和影响正在向亚洲和印度转移。因此，我们在浦那的CTU处于独特的地位，可以为预防婴儿艾滋病毒感染和优化受感染儿童的治疗的全球努力做出贡献。 管理组件：

DESCRIPTION (provided by applicant): The Indo-US collaborative research group, at the Byramjee Jeejeebhoy Medical College (BJMC) in Pune, India, is currently conducting the only NIH-sponsored; Phase III randomized clinical trial for prevention of mother-to-child HIV transmission (MTCT) in India. In response to this RFA, we propose a Clinical Trials Unit (CTU) with a single Clinical Research Site (CRS) that will build upon the success of our existing leadership, organization, clinical trials management procedures, as well as our experienced investigators and staff. Our CTU proposes to participate in trials that will address two research priority areas: 1) Prevention of MTCT and 2) Optimization of Clinical Management of HIV-infected Children. Johns Hopkins University (JHU) will be the primary grantee and will support the CTU leadership, administration, community activities and a single CRS in Pune, through two subcontracts (BJMC and ED SEARCH). BJMC will provide scientific and administrative leadership to the CTU, as well as clinical/laboratory infrastructure and clinical care support for the CRS. BJMC will also utilize the help of the National AIDS Research Institute for specialized laboratory support. ED SEARCH, a registered, Indian, non-profit Trust will provide scientific and administrative leadership, as well as day-to-day management of the CRS, regulatory requirements and good clinical practices. ED SEARCH will also manage support of our Community Advisory Board, as well as our trial recruitment program in 21 community-based clinics run by the Pune Municipal Corporation and the Pimpri Chinchwad Municipal Corporation. Our application reflects a fully-functional, experienced, actively-enrolling CTU that has more than three years of experience conducting the only Phase III HIV prevention clinical trial in India. We also have significant infrastructure, a proven GCP track record, and documented capacity for enrollment and retention of mothers and infants. Since August 2003, our CRS has provided HIV voluntary counseling and testing to more than 54,000 pregnant women in Pune. We have enrolled 593 HIV-infected mothers (20/month) in our current MTCT trial. Our capacity for pediatric treatment trials is supported by our active follow-up of 160 HIV-infected children and a supportive community-based referral program. The trajectory and impact of the global HIV epidemic is shifting to Asia and to India. Therefore, our CTU in Pune is uniquely positioned to contribute to the global efforts to prevent infant HIV infection and to optimize treatment of infected children. ADMINISTRATIVE COMPONENT: