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

描述（由申请人提供）： 位于印度浦那的Byramjee Jeejeebhoy医学院（BJMC）的印美合作研究小组目前正在进行唯一一项由NIH赞助的第三期随机临床试验，以预防印度母婴艾滋病毒传播（MTCT）。为应对这一RFA，我们建议设立一个临床试验部门（CTU），并设立一个临床研究中心（CRS），该中心将建立在我们现有的领导层、组织、临床试验管理程序以及经验丰富的研究者和工作人员的成功基础上。我们的CTU提议参与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）将是主要的受赠方，并将通过两个分包合同（BJMC和艾德学校）支持CTU的领导、行政、社群活动和浦那的单一CRS。BJMC将为CTU提供科学和行政领导，以及为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。艾德基金会是一家注册的印度非营利性信托基金会，将提供科学和行政领导，以及CRS、监管要求和良好临床实践的日常管理。艾德还将管理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市政公司经营的21个社区诊所的试验招募计划。我们的申请反映了一个功能齐全，经验丰富，积极注册的CTU，拥有三年多的经验，在印度进行了唯一的III期艾滋病毒预防临床试验。我们还拥有重要的基础设施，经过验证的GCP跟踪记录，以及登记和保留母婴的记录能力。自2003年8月以来，我们的天主教救济会在浦那为54 000多名孕妇提供了艾滋病毒自愿咨询和检测。我们在目前的母婴传播试验中招募了593名感染艾滋病毒的母亲（20名/月）。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随访和支持性社区转诊计划的支持。全球艾滋病毒流行病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，可以为全球预防婴儿艾滋病毒感染和优化受感染儿童治疗的努力做出贡献。 行政部门：

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: