PEDIATRICS AIDS CLINICAL TRIALS GROUP

描述（由申请人提供）：本申请是为了延续 哥伦比亚大学儿科艾滋病临床试验单位（PACTU）。这个单位 有三个组成部分，哥伦比亚的妇女和儿童护理中心的主要单位 中心（WCCC），一个亚单位化身儿童中心（ICC），和一个新的 纽约长老会医院康奈尔设施的亚单位。主要 该PACTU的单位位于纽约市的上西区， 艾滋病毒感染率高的地理位置，特别是妇女 和儿童康奈尔大学的网站正在跟踪大量的艾滋病毒感染者， 青少年。主要研究者（PI）和其他研究人员 所有研究中心都是经验丰富的艾滋病临床试验研究人员， 哥伦比亚大学内科医学院的全职教员 外科医生或康奈尔大学有一个儿科艾滋病毒认证的ACTG 哥伦比亚的病毒学实验室在WCCC，工作人员的交织 参与了NIH支持的关于女性艾滋病毒传播的艾滋病毒研究 他们的后代（WITS）和ACTG临床试验提供了一个独特的 将患者从一项HIV研究转入另一项研究的机会， 因此，在PACTG协议中，妇女和儿童获得的机会很高。 所有研究中心服务的代表性患者人群主要是 贫困、来自少数群体和社会弱势群体。过去 12年来，我们已经招募了大量患者进入ACTG方案， 在过去5年中，平均每年有50例受试者进入方案。过去 12年来，我们的患者累计入组人数超过450例。与 由于WITS研究在当地的存在，我们预计将有大量的HIV感染者入组， 妇女进入围产期研究。根据我们过去的表现， 关于应计、数据管理、遵守监管要求， 并对ACTG的研究议程作出重大贡献，我们是 恳请资助我们单位今后的研究。我们有 他们的目标不仅是提供富有同情心的 艾滋病毒感染者的医疗护理，而且还进行有意义的， 对预防和治疗艾滋病毒感染的有益研究。

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.