AIDS CLINICAL TRIALS

艾滋病临床试验

• 批准号: 2067811
• 负责人: WALTER T HUGHES
• 金额: $ 91.58万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-03-01 至 1997-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2067811
• 关键词: AIDS; Pneumocystis carinii; adolescence (12-20); child (0-11); clinical trials; congenital infection; cooperative study; flow cytometry; human immunodeficiency virus 1; human subject; opportunistic infections; pediatric AIDS; social service

The prevalence of pediatric AIDS is rapidly escalating in the Mid-South; during 1988 to 1990 the prevalence of perinatal AIDS reached rates comparable to those in California, Texas, Illinois and Michigan. Two factors account for the relatively high rate of perinatal AIDS in the Mid- South: the high prevalence of HIV in young African-American women and the large population of this risk group in the South. The prevalence of HIV infection in African-American women of childbearing age is about tenfold higher than in corresponding white women, both nationally and locally. Memphis has the 9th largest urban black population in the U.S. and the adjoining states of Mississippi, Tennessee and Arkansas rank 1st, 10th and 11th, respectively, in proportion of African-American residents among the states. St. Jude Children's Research Hospital is a major pediatric cancer center. Three years ago a research program in pediatric AIDS was started and has been successful in completion of phase I and II studies of anti-HIV and anti-P. carinii agents. Some of these studies involved collaboration with The Regional Medical Center (The Med) and Le Bonheur Children's Medical Center. The current proposal is to build upon the existing ongoing multi- disciplinary program and to establish a pediatric ACTU centered at St. Jude with research subunits at The Med and Le Bonheur. This center will participate in the national pediatric ACTU network. Patients will be enrolled in maternal-infant transmission studies and phase I, II and III protocols for HIV and opportunistic infections. Phase I studies will have high priority. The catchment area will serve patients within a radius of about 300 miles from Memphis, a region otherwise without access to experimental drugs for HIV infection. Among the unique strengths of the proposed pediatric ACTU are its location at a leading and the world's largest pediatric cancer research center; a large contingent of pediatric infectious disease specialists highly experienced in designing and conducting clinical trials in immunocompromised children; an environment fostering interaction of physician-scientists and basic scientists; remarkably low attrition rates for clinical trials, including trials in AIDS patients; ancillary support anchored by the resources and experienced personnel at St. Jude, The Med and Le Bonheur; and access to a large, underserved minority population in the Mid-South.

儿童艾滋病的流行在中南部地区迅速上升； 1988年至1990年期间，围产期艾滋病的流行率达到了 与加利福尼亚州、德克萨斯州、伊利诺伊州和密歇根州的情况不相上下。二 中老年人围产期艾滋病发病率较高的原因 南方：年轻的非裔美国妇女中艾滋病毒的高流行率和 这一风险群体在南方有大量的人口。艾滋病毒的流行 非裔美国育龄妇女的感染率约为10倍 无论是在全国还是在当地，这一比例都高于相应的白人女性。 孟菲斯拥有美国第九大城市黑人人口， 毗邻的密西西比州、田纳西州和阿肯色州分别位居第一、第十和 在非洲裔美国人居民中分别占第11位 各州。 圣犹大儿童研究医院是一家主要的儿科癌症中心。 三年前，启动了一项关于儿童艾滋病的研究计划，并 成功地完成了第一和第二阶段的抗艾滋病毒和 抗P。卡里尼特工。其中一些研究涉及与 地区医疗中心(地中海)和Le Bonheur儿童医疗中心 中心。目前的建议是在现有的正在进行的多- 纪律方案，并建立以圣犹大为中心的儿科ACTU 在地中海和Le Bonheur设有研究分部。这个中心将 参加全国儿科ACTU网络。病人将会是 参加母婴传播研究和第一、第二和第三阶段 艾滋病毒和机会性感染的方案。第一阶段研究将有 高优先级。集水区将为方圆范围内的病人服务 距离孟菲斯约300英里，这是一个原本无法进入的地区 治疗艾滋病毒感染的实验药物。 拟议的儿科ACTU的独特优势之一是它的地理位置 在一家领先的、世界上最大的儿科癌症研究中心； 一大批儿科传染病专家 有设计和实施临床试验的经验 免疫功能低下的儿童；促进互动的环境 内科科学家和基础科学家；极低的流失率 临床试验，包括对艾滋病患者的试验；辅助支持 依靠圣犹大的资源和经验丰富的人员，地中海 和Le Bonheur；以及获得大量未得到充分服务的少数族裔人口 中南部。