PEDIATRIC AIDS CLINICAL TRIALS GROUP

此申请是为了继续儿科艾滋病临床 试验（ACTU）在哥伦比亚大学，为10-14年的项目。 该股有两个组成部分，一个是婴儿医院的主要单位， 妇女和儿童护理中心（WCCC）和一个亚单位化身 儿童中心（ICC）是一个提供喘息机会的住宅中心， 为感染艾滋病毒的儿童提供临终关怀和临床护理， 寄养家庭这个ACTU位于上西区 纽约市的艾滋病毒高流行率地区 感染，特别是妇女和儿童。PI和其他 研究人员是经验丰富的艾滋病临床试验研究人员， 是哥伦比亚大学学院的全职教师， 内科医生和外科医生。有一个儿科艾滋病毒认证的ACTG 病毒实验室在现场。在婴儿医院， 参与NIH支持的HIV病毒传播研究的工作人员 艾滋病毒从妇女传给后代（WITS）和ACTG临床试验 提供了一个独特的机会，病人从一个艾滋病毒 一项研究进入另一项研究，从而使妇女有更多的机会接触 和儿童在ACTG协议。代表性患者人群 这两个机构所服务的人大多是贫困的， 社会弱势群体。在过去的五年里， 婴儿医院和ICC协同合作， 将大量患者纳入ACTG方案。我们平均 每年有18名新感染艾滋病毒的儿童参加方案， 过去我们还让许多儿童参加了多项方案 因此，在过去的9年里，我们的病人增加了超过 250例登记。今年我们已经招收了更多的 患者超出了最初计划的累积。在当地的存在 以及与哈莱姆医院建立的新关系 产科，我们预计大大增加 将感染艾滋病毒的妇女纳入围产期研究。基于我们 过去的表现，我们认为已经是一个杰出的水平， 关于应计、数据管理、遵守监管 的要求，并对研究议程作出重大贡献， 在ACTG，我们恭敬地要求我们的单位得到资助， 以便进行未来的研究。我们对未来的计划是 集中精力进行围产期研究和1期初级 妇女、婴儿和儿童的抗逆转录病毒研究。我们进一步希望 为青少年建立一个项目。我们还将参加 我们应充分利用我们的资源，制定关于预防和 治疗机会性感染，并记录有关长期 HIV感染者的长期结局。我们相信我们的ACTU 为患者提供了重要的途径， 杰出的，杰出的 工作人员的目标不仅是提供富有同情心的医疗服务， 而且对艾滋病病毒感染者进行有意义和有益的 艾滋病防治研究。

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.