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)是一项新的研究合作，代表来自儿科艾滋病临床试验小组(PACTG)和艾滋病毒预防试验网络(HPTN)的围产期科学工作组的研究人员的合并。IMPAACT网络的使命将是显著降低孕妇、儿童和青少年中与艾滋病毒疾病相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)，根据事先的领导协议，该单位将作为IMPAACT网络中的优先地点加入。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站点以及德雷克塞尔大学医学院/哈内曼大学医院的一个产妇/围产期站点组成。PICTU将响应IMPAACT领导层确定的所有四个优先研究领域，包括：1)疫苗研究和开发，2)转化研究和药物开发，3)优化临床管理，包括共病，以及4)预防艾滋病毒母婴传播。PICTU将作为该网络的一个国内单位。PICTU的定位是满足IMPAACT网络的注册要求。2004年，有453名0至24岁的艾滋病毒感染儿童和青年，几乎所有人都由我们的儿科网站提供服务。费城艾滋病毒社区组织严密，积极支持该地区向新的艾滋病毒/艾滋病试验网络过渡，Pictu调查人员已与当地社区组织和行动团体建立了联系。PI、参与调查人员和高级专业人员在招募和保留孕妇、婴儿、儿童和青少年参加艾滋病毒临床试验方面拥有广泛的经验和成功，并在NIH赞助的HIWAIDS研究以及PACTG和其他艾滋病毒/艾滋病研究网络(REACH、ATN、HPTN)的领导和科学贡献方面有着良好的过去记录。拟议的临床研究地点及其人员过去作为PACTG单位进行了成功的合作，并在法规遵从性、及时提交数据、数据管理和登记方面表现出始终如一的良好记录。参与的临床研究站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了专业知识，并完全有资格实施IMPAACT方案，并为该网络的科学议程做出贡献。 管理组件：

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: