Johns Hopkins AIDS Clinical Trials Unit

描述（由申请人提供）： 约翰霍普金斯大学是艾滋病临床研究的国家和国际领导者。拟议中的约翰霍普金斯大学艾滋病临床试验单位（CTU）将汇集三个独立资助的艾滋病临床研究小组，进行（1）成人和（2）儿科治疗试验，以及（3）艾滋病预防研究。这三个小组将组成一个统一的CTU，为位于东巴尔的摩的约翰霍普金斯医疗机构的一个临床研究中心（CRS）的三个DAIDS临床研究网络提供服务。该研究中心将隶属于拟议的（1）艾滋病临床试验组（ACTG）网络，（2）国际孕产妇儿童青少年艾滋病临床泰国（IMPAACT）网络，（3）艾滋病毒预防试验网络（HPTN）。 我们长期以来一直为DAIDS科学议程做出实质性贡献，特别是在预防和治疗试验、早期药物开发和实验治疗、神经病学、肝炎病毒和HIV合并感染以及儿科、青少年和母胎研究等领域。这个拟议中的CTU的研究人员已经撰写了1,000多篇与艾滋病毒感染有关的论文，其中300多篇是在过去五年中发表的。同样的研究人员持有21个与艾滋病毒相关的NIH资助的赠款作为主要研究者或共同主要研究者，每年的直接费用超过700万美元。我们现有的成人ACTG单位在招募非洲裔美国人和妇女方面在全国排名第一，其中许多人有药物滥用史。数据管理被评为优秀，受试者保留是模范。CRS将从为3万多名艾滋病毒感染者和高危人群提供服务的附属诊所招募人员。这个新的CTU将汇集一大群有着良好合作历史的有成就的研究者，并将整合监管事务、数据管理、外联和招聘的行政资源。 在保留我们目前艾滋病毒临床试验结构的成功方面的同时，这种重组将通过提供一个集中的、共享的行政核心使该机构受益，这将使约翰霍普金斯以前不可能实现的规模经济成为可能。最重要的是，这三个团体的联合将使从出生到青春期到成年和衰老的各个年龄段的人都能获得艾滋病毒预防和治疗研究。该CTU有能力继续为国家和国际艾滋病毒临床研究做出广泛和实质性的贡献，同时也为社区服务。 行政部门：

DESCRIPTION (provided by applicant): The Johns Hopkins University is a national and international leader in HIV clinical research. The proposed Johns Hopkins University AIDS Clinical Trials Unit (CTU) will bring together three independently funded HIV clinical research groups that perform (1) adult and (2) pediatric treatment trials, and (3) HIV prevention research. These three groups will form a unified CTU serving three DAIDS clinical research networks at one Clinical Research Site (CRS), The Johns Hopkins Medical Institutions in East Baltimore. The Site will be affiliated with the proposed (1) AIDS Clinical Trials Group (ACTG) Network, (2) International Maternal Pediatric Adolescent AIDS Clinical Thais (IMPAACT) Network, (3) HIV Prevention Trials Network (HPTN). We have a long history of substantive contribution to the DAIDS scientific agenda, especially in the areas of prevention and treatment trials, early phase drug development and experimental therapeutics, neurology, hepatitis virus and HIV co-infection, and pediatric, adolescent, and maternal-fetal research. The investigators in this proposed CTU have authored over 1,000 published papers related to HIV infection, >300 of these in the past five years. The same investigators hold 21 HIV-related NIH-funded grants as Principal Investigator or Co-Principal Investigator for over $7,000,000 in annual direct costs. Our existing Adult ACTG Unit ranks first nationally in recruitment of African-Americans and women, many of whom have a history of substance abuse. Data management is rated outstanding, and subject retention is exemplary. The CRS will recruit from affiliated clinics serving more than 30,000 HIV-infected and at-risk persons. This new CTU will bring together a large group of accomplished investigators with a strong history of collaboration, and will allow consolidation of administrative resources for regulatory affairs, data management, outreach, and recruitment. While preserving the successful aspects of our current HIV clinical trials structure, this reorganization will benefit the institution by providing a centralized, shared administrative core, which will allow an economy of scale that has not previously been possible at Johns Hopkins. Above all, the joining together of these three groups will provide access to HIV prevention and treatment research across the age spectrum, from birth to adolescence to adulthood and senescence. This CTU is well-positioned to continue its broad and substantial contributions to national and international HIV clinical research, while also serving its community. ADMINISTRATIVE COMPONENT: