St. Jude/Memphis IMPAACT Clinical Trials Unit (Composite)

描述（由申请人提供）：临床研究，其中大部分由NIAID资助，显着提高了HIV/AIDS患者的生存率。然而，这一流行病在发达世界和发展中世界都在继续增长。在美国，少数群体，特别是非洲裔美国人，在全国范围内受到不成比例的影响。在全国范围内，非洲裔美国人占艾滋病病例的40%，但只占美国人口的12.3%。这种差异在儿童和青少年（13至19岁）中更大，其中非洲裔美国人占艾滋病病例的60%，但只占美国人口的15%。在孟菲斯，大约46%的人口是非裔美国人，但90%的艾滋病毒和艾滋病病例发生在非裔美国人身上。此外，美国疾病控制与预防中心的数据显示，累计报告的所有艾滋病病例中有36%发生在南方，但2003年南方占新发艾滋病病例的45%。这些数据证实了该流行病在该区域的不成比例的增长。由于美国HIV感染流行病学的不断发展，孟菲斯是国内HIV/AIDS临床试验单位（CTU）的理想地点。孟菲斯是美国南部的一个大城市，为田纳西州、密西西比州、密苏里州和阿肯色州方圆约200英里的居民提供三级医疗服务。这个地区被认定为全国最贫穷的地区之一。在这里，拟议的CTU设在：圣犹达儿童研究医院，将为受该流行病影响最严重的代表性不足的人群提供临床试验机会；，包括妇女、青少年和非裔美国人。拟议中的CTU目前是一个儿科艾滋病临床试验小组，隶属于国际孕产妇儿科青少年临床试验小组（IMPAACT）。该单位将与田纳西大学健康科学中心签订财团协议，在St. Jude拥有一个单一的站点。该股将处理影响行动的所有四个科学目标：预防艾滋病毒母婴传播；转化研究/药物开发；包括合并症在内的临床管理优化以及疫苗研发。基于严重受影响人群的可用性、经验丰富的工作人员、临床试验行为的悠久历史和对PACTG的科学贡献，圣裘德CTU将成为impact act的一个有价值的国内单位。

DESCRIPTION (provided by applicant): Clinical research, much of it sponsored by NIAID, has markedly improved survival of patients with HIV/AIDS. However, the epidemic continues to grow both in both developed and the developing world. In the U.S., minority groups, especially African-Americans, are disproportionately affected throughout the country. Nationally, African-Americans make up 40% of AIDS cases but only 12.3% of the U.S. population. This disparity is even greater among children and adolescents (ages 13 to 19 years), among whom African Americans make up 60% of AIDS cases but only 15% of the U.S. population. In Memphis, approximately 46% of the population is African-Americans but 90% of the HIV and AIDS cases occur n African-Americans. In addition, data from the CDC show that cumulatively, 36% of all reported AIDS cases have been in the South, but the South accounted for 45% of new AIDS cases in 2003. These data confirm the disproportionate growth of the epidemic in this region. Because of the evolving epidemiology of HIV infection in the U.S., Memphis is an ideal location for a domestic HIV/AIDS Clinical Trial Unit (CTU). Memphis is a large Southern urban area that provides tertiary health care for individuals in an approximately 200-mile radius in the states of Tennessee, Mississippi, Missouri, and Arkansas. This area has been identified as one of the poorest in the nation. Here, the proposed CTU, located at: St. Jude Children's Research Hospital, will provide clinical trial access for to underrepresented populations that are most severely affected by the epidemic;, including women, adolescents, and African-Americans. The proposed CTU is currently a Pediatric AIDS Clinical Trials Group Unit and is affiliated with the International Maternal Pediatric Adolescent Clinical Trials (IMPAACT) Group. The unit will have a single site located at St. Jude with a consortium agreement with the University of Tennessee Health Science Center. The unit will address all four scientific aims of IMPAACT: Prevention of Maternal to Child Transmission of HIV; Translational Research/Drug Development; Optimization of Clinical Management including Co- Morbidities; and Vaccine Research and Development. Based on the availability of severely affected populations, the experienced staff, and the strong history of clinical trial conduct and scientific contributions to the PACTG, the St Jude CTU will be a valued domestic unit for IMPAACT. ADMINISTRATIVE COMPONENT: