PEDIATRIC AIDS CLINICAL TRIALS GROUP

此申请是为了延续儿科艾滋病诊所 在哥伦比亚大学试验(ACTU)，为期10-14年的项目。 该股有两个组成部分，主要设在婴儿医院，在 妇女儿童护理中心(WCCC)和一个亚单位的化身 儿童中心(ICC)提供喘息机会的居住中心， 为感染艾滋病毒的儿童提供临终关怀和临床护理，其中许多儿童 在寄养中心。这个ACTU位于上西区 位于艾滋病毒高发区的纽约市 感染，特别是在妇女和儿童中。私人侦查员和其他 研究人员是艾滋病临床试验的经验丰富的调查人员，每个人 是哥伦比亚大学学院的全职教员 内科医生和外科医生。有一家经艾滋病毒认证的儿科ACTG 现场的病毒学实验室。在婴儿医院交织在一起的 参与美国国立卫生研究院支持的艾滋病毒病毒传播研究的工作人员 从妇女进入子代的艾滋病毒(WITS)和ACTG临床试验 为患者从一种HIV病毒中转移提供了独特的机会 学习另一种，从而导致接触妇女的机会很高 以及ACTG方案中的儿童。有代表性的患者群体 这两个机构所服务的人大多是贫困的，从少数人 群体和社会弱势群体。在过去的五年中， 婴儿医院和国际刑事法院协同合作， 将大量患者纳入ACTG方案。平均而言，我们 每年都有18名新的艾滋病毒感染儿童加入方案 过去的事。我们还让许多儿童参加了多种方案 因此，在过去的9年里，我们的患者收益超过了 招生人数250人。今年我们已经招收了更多的学生 以上患者按原计划计提。与当地的存在 WITS研究和与哈莱姆医院新建立的关系 产科，我们预计会有更大的 将感染艾滋病毒的妇女纳入围产期研究。基于我们的 我们认为，过去的表现一直是出色的 关于应计、数据管理、法规遵从性 要求，以及对研究议程的重大贡献 ACTG，我们恭敬地请求为我们的部队 以便进行未来的研究。我们对未来的计划是 将我们的精力集中在围产期研究和第一阶段小学 妇女、婴儿和儿童的抗逆转录病毒研究。我们进一步希望 建立一项针对青少年的计划。我们还将参加 在协议中充分利用我们的资源，以解决防止和 治疗机会性感染并记录有关Long的信息 艾滋病毒感染者的长期结局。我们相信我们的反恐小组 为患者提供了重要的途径，进而提供了 杰出的医疗水平，杰出的 他们的目标不仅是为 艾滋病毒感染者也要做有意义和有用的事情 艾滋病病毒的防治研究。

This application is for continuation of a Pediatric AIDS Clinical Trials (ACTU) at Columbia University, for years 10-14 of the project. The Unit has two components, the main unit at Babies Hospital, in the Women and Children's Care Center (WCCC) and a subunit Incarnation Children's Center (ICC) a residential center that provides respite, hospice and clinical care for HIV infected children many of whom are in foster care. This ACTU is located 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 PIs and other researchers 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. There is a Pediatric HIV-certified ACTG virology laboratory on site. At Babies Hospital the interweaving of staff involved in NIH-supported HIV studies of viral transmission of HIV from women into 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 ACTG protocols. The representative patient population served by the two institutions are largely impoverished, from minority groups, and socially disadvantaged. For the past five years, staff at the Babies Hospital and ICC have worked together synergistically to enroll a large number of patients into ACTG protocols. On average, we have enrolled 18 new HIV-infected children into protocols annually in the past. We have also enrolled many children into multiple protocols so that over the past 9 years our patient accrual has been more than 250 enrollments. In the current year we have already enrolled have more patients above out originally planned accrual. With the local presence of the WITS study and a newly forged relationship with Harlem Hospital Department of Obstetrics, we anticipate significantly greater enrollment of HIV-infected women into perinatal studies. Based on our past performance at what we believe has been an outstanding level of regarding 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 in order to perform future research studies. Our plans for the future are to concentrate our efforts on perinatal studies and Phase 1 primary antiretroviral studies in women, infants and children. We further hope to establish a program for adolescents. We will also participate to the fullest of our resources in protocols that address means to prevent and treat opportunistic infections and to record information regarding long term outcomes of HIV-infected patients. We believe that our ACTU provides significant access to patients and in turn offers an outstanding an outstanding level of medical competence, an 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.