EXPANSION OF THE PEDIATRIC AIDS CLINICAL TRIAL UNIT

扩大儿科艾滋病临床试验中心

• 批准号: 3548005
• 负责人: WALTER T HUGHES
• 金额: $ 69.51万
• 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/3548005
• 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.

儿童艾滋病的流行率在中南地区迅速上升; 1988年至1990年期间，围产期艾滋病的流行率达到了 与加州、德克萨斯州、伊利诺斯州和密歇根州的情况相当。 两 这些因素导致了中期围产期艾滋病发病率相对较高， 南方：年轻非洲裔美国妇女艾滋病毒的高流行率和 南方有大量该风险群体。 艾滋病毒流行率 非洲裔美国育龄妇女的感染率约为 高于相应的白色妇女，无论是在全国还是在地方。 孟菲斯拥有美国第九大城市黑人人口， 毗邻的密西西比、田纳西和阿肯色州分别排在第1、第10和 第11位，分别是非洲裔美国居民在 states. 圣裘德儿童研究医院是一个主要的儿科癌症中心。 三年前，一项儿科艾滋病研究计划启动， 成功完成了抗艾滋病毒的I期和II期研究， 抗卡氏肺孢子虫药物。 其中一些研究涉及与 地区医疗中心（The Med）和Le Bonheur儿童医疗中心 中心 目前的建议是在现有的多方面基础上， 学科计划，并建立一个儿科ACTU为中心的圣裘德 在地中海和博纳尔的研究小组工作 这个中心将 参加全国儿科ACTU网络。 患者将 参加母婴传播研究和I、II、III期研究的 艾滋病毒和机会性感染的协议。 I期研究将有 最高优先级 集水区将为半径 距离孟菲斯约300英里，否则无法进入该地区 艾滋病毒感染的实验性药物。 在拟议的儿科ACTU的独特优势是它的位置 在一个领先的和世界上最大的儿科癌症研究中心; 庞大的儿科传染病专家队伍高度重视 设计和开展临床试验的经验， 免疫功能低下的儿童;一个环境，促进互动 医生科学家和基础科学家;非常低的流失率 临床试验，包括艾滋病患者试验;辅助支持 以St. Jude的资源和经验丰富的人员为基础，The Med 和Le Bonheur;以及获得大量服务不足的少数民族人口， 中南。