PEDIATRICS AIDS CLINICAL TRIALS GROUP

描述(由申请人提供)：本申请是为延续 哥伦比亚大学儿童艾滋病临床试验中心(PACTU)。本单位 有3个组成部分，哥伦比亚大学妇女和儿童保育部的主要单位 中心(WCCC)，一个亚单位化身儿童中心(ICC)，以及一个新的 纽约长老会医院康奈尔分部。主 PACTU的小分队位于纽约市的上西区 艾滋病毒高流行率的地理位置，特别是在妇女中 还有孩子。康奈尔大学的网站关注着大量感染艾滋病毒的人 青少年。首席调查员(PI)和其他研究人员 在所有地点都有艾滋病临床试验的经验丰富的研究人员，每个地点都是 哥伦比亚大学医学院全职教员 外科医生或康奈尔大学。有一家经艾滋病毒认证的儿科ACTG 哥伦比亚大学现场病毒学实验室。在WCCC，员工的相互交织 参与美国国立卫生研究院支持的艾滋病毒从妇女传播的艾滋病毒研究 对其后代(WITS)和ACTG的临床试验提供了一种独特的 患者从一项艾滋病毒研究转到另一项研究的机会，因此 因此，在PACTG议定书中接触妇女和儿童的机会很高。 所有站点服务的具有代表性的患者人群主要是 贫困、来自少数群体和社会弱势群体。为了过去 12年来，我们招募了大量患者参加ACTG方案， 在过去的5年里，平均每年有50名受试者加入到方案中。在过去的时间里 12年来，我们的患者累计登记人数已超过450人。与 WITS研究的本地存在，我们预计会有大量的艾滋病毒感染者登记 妇女进入围产期研究。基于我们过去的表现， 关于应计费用、数据管理、遵守法规要求、 和对ACTG研究议程的重大贡献，我们是 敬请为我们单位未来的研究提供资金。我们有 称职、杰出的员工，他们的目标不仅是提供富有同情心的 对艾滋病毒感染者的医疗护理，也是有意义的和 在预防和治疗艾滋病毒感染方面的有益研究。

DESCRIPTION (provided by applicant): This application is for continuation of a Pediatric AIDS Clinical Trials Unit (PACTU) at Columbia University. This Unit has 3 components, the main unit at Columbia in the Women and Children's Care Center (WCCC), a subunit Incarnation Children's Center (ICC), and a new subunit at the Cornell facility of New York-Presbyterian Hospital. The main unit of this PACTU is located in the Upper West Side of New York City in a geographic location of high prevalence of HIV infection, especially in women and children. The Cornell site is following a significant number of HIV-infected adolescents. The principal investigators (PIs) and other researchers at all sites are seasoned investigators in AIDS clinical trials and each is a full time member of the faculty at Columbia University College of Physicians and Surgeons or Cornell University. There is a Pediatric HIV-certified ACTG virology laboratory on site at Columbia. At WCCC the interweaving of staff involved in NIH-supported HIV studies of viral transmission of HIV from women to their offspring (WITS) and ACTG clinical trials provides a unique opportunity for rollover of patients from one HIV study into another, thus resulting in a high level of access to women and children in PACTG protocols. The representative patient population served by all sites are largely impoverished, from minority groups, and socially disadvantaged. For the past 12 years, we have enrolled a large number of patients into ACTG protocols, on average 50 subjects annually into protocols in the past 5 years. Over the past 12 years our patient accrual has been more than 450 enrollments. With the local presence of the WITS study, we anticipate significant enrollment of HIV-infected women into perinatal studies. Based on our past performance with regard to accrual, data management, compliance with regulatory requirements, and significant contributions to the research agenda of the ACTG, we are respectfully requesting that our unit be funded for future studies. We have competent, outstanding staff whose aim is not only to provide compassionate medical care to HIV-infected patients but also to perform meaningful and useful research on prevention and treatment of HIV infection.