Philadelphia IMPAACT Clinical Trials Unit

描述（由申请人提供）：国际母婴青少年艾滋病临床试验网络（IMPAACT）是一个新的研究合作，代表了儿科艾滋病临床试验组（PACTG）和艾滋病预防试验网络（HPTN）围产期科学工作组的研究人员的合并。影响行动网络的任务将是大幅度降低孕妇、儿童和青少年中与艾滋病毒疾病有关的死亡率和发病率。我们建议建立一个费城IMPAACT临床试验单位（PICTU），通过事先的领导协议，作为IMPAACT网络的优先站点。这个CTU将由一个行政部门、费城儿童医院和圣克里斯托弗儿童医院的两个儿科临床研究中心，以及德雷塞尔大学医学院/哈内曼大学医院的一个产妇/围产期中心组成。PICTU将响应IMPAACT领导层确定的所有四个优先研究领域，包括：1)疫苗研究与开发；2)转化研究和药物开发；3)优化临床管理，包括合并发病；4)预防艾滋病毒母婴传播。职工大会将作为该网络的一个国内单位。PICTU的定位是满足IMPAACT网络的入学要求。2004年，有453名0至24岁的感染艾滋病毒的儿童和青年，他们几乎都在我们的儿科诊所接受治疗。费城艾滋病社区组织良好，积极支持该地区向新的艾滋病毒/艾滋病试验网络过渡，PICTU调查人员与当地社区组织和行动团体建立了联系。PI、参与的研究人员和高级专业人员在HIV临床试验中招募和保留孕妇、婴儿、儿童和青少年方面具有广泛的经验和成功，并且在nih赞助的HIV研究以及PACTG和其他HIV/AIDS研究网络（REACH、ATN、HPTN）中具有强大的领导和科学贡献记录。拟议的临床研究地点及其人员在过去作为PACTG单位成功合作，并在法规遵从、及时提交数据、数据管理和登记方面表现出一贯的优异记录。参与的临床研究点在设计随机对照临床治疗试验、药代动力学、免疫学、病毒学和药理学研究方面表现出专业知识，完全有资格执行IMPAACT协议并为网络的科学议程作出贡献。

DESCRIPTION (provided by applicant): The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a new research collaboration representing a merger of investigators from the Pediatric AIDS Clinical Trials Group (PACTG) and the Perinatal Scientific Working Group of the HIV Prevention Trials Network (HPTN). The mission of the IMPAACT Network will be to significantly decrease the mortality and morbidity associated with HIV disease in pregnant women, children, and adolescents. We propose to establish a Philadelphia IMPAACT Clinical Trials Unit (PICTU) that will affiliate, by prior leadership agreement, as a priority site within the IMPAACT Network. This CTU will be comprised of an Administrative Component, two pediatric clinical research sites at the Children's Hospital of Philadelphia and St. Christopher's Hospital for Children, and a maternal/perinatal site at the Drexel University College of Medicine/Hahnemann University Hospital. The PICTU will respond to all four priority research areas identified by the IMPAACT leadership including: 1) Vaccine Research and Development, 2) Translational Research and Drug Development, 3) Optimization of Clinical Management including Co-Morbidity, and, 4) Prevention of Mother-to-Child Transmission of HIV. The PICTU will serve as a domestic unit within the Network. The PICTU is positioned to meet the enrollment requirements for the IMPAACT network. In 2004, there were 453 HIV-infected children and youth between 0 and 24 years of age, nearly all of whom are served by our pediatric sites. The Philadelphia HIV community is well-organized and highly-motivated to support the transition to new HIV/AIDS trial networks in the region and PICTU investigators have established ties with local community organizations and action groups. The PI, participating investigators, and senior professional staff have broad experience and success in the enrollment and retention of pregnant women, infants, children, and adolescents in HIV clinical trials, as well as a strong past record of leadership and scientific contributions in NIH-sponsored HIWAIDS research and within the PACTG and other HIV/AIDS research networks (REACH, ATN, HPTN). The proposed clinical research sites and their personnel have collaborated successfully as a PACTG unit in the past and have demonstrated a consistently excellent record of regulatory compliance, timely data submission, data management, and enrollment. The participating clinical research sites have demonstrated expertise in design of randomized controlled clinical treatment trials, pharmacokinetic, immunologic, virologic, and pharmacologic studies and are well-qualified to conduct IMPAACT protocols and contribute to the Network's scientific agenda. ADMINISTRATIVE COMPONENT: