PEDIATRIC AIDS CLINICAL TRIALS UNIT

儿科艾滋病临床试验单位

• 批准号: 2063896
• 负责人: CATHERINE M WILFERT
• 金额: $ 135.01万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-06-01 至 1997-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2063896
• 关键词: AIDS therapy; HIV infections; clinical trials; cooperative study; human subject; human therapy evaluation; pediatric AIDS

The state of North Carolina currently has two pediatric AIDS Clinical Trials Units. A complete pediatric ACTU has been at Duke since January 1987, with funding provided as part of a mixed adult/pediatric AIDS Treatment Evaluation Unit until 1989. The University of North Carolina at Chapel Hill has been seeing children at a pediatric component of an Adult ACTU since 1990. Affiliated with the UNC subunit is a small perinatal program at the Carolinas Medical Center in Charlotte, NC. We propose to merge these three sites and two other units, at Brenner Children's Hospital in Winston-Salem and East Carolina University Medical School in Greenville, into a single unified program, the North Carolina Children's AIDS Network (NC-CAN). All five sites will be capable of enrolling children into ACTG pediatric protocols, and 4 of the 5 will enroll children onto perinatal studies (ECU will not). The unification of these programs will serve several purposes: 1) Access to ACTG protocols will be improved. North Carolina is the tenth largest state in population, but its citizens and its HIV infected children are evenly divided between urban and rural settings. The 5 sites are geographically distributed and are near the highest HIV seroprevalence regions of the state. 2) All of the state's medical schools will be working together in a unified manner, decreasing competition and allowing for more efficient utilization of resources. In addition, medical students and residents from across the state will be exposed to the growing problem of pediatric HIV and trained to provide care for these difficult patients. 3) The research skills of the 5 institutions can be pooled and applied to the critical mass of patients who will enroll in the NC-CAN system. 4) The NC-CAN will provide a model for the provision of research based care in a rural setting. The Southeast has the largest number of heterosexually transmitted AIDS cases in the United States, and in North Carolina the HIV seroprevalence among women is rapidly escalating. The NC-CAN will demonstrate methods to perform clinical research in this type of population which will then be applicable as the epidemic spreads to other non-urban sectors of the country. As an example of the current success of the programs, despite the fact that patients travel a median of more than 90 minutes each way to get to Duke and UNC, the clinic show rate is 88% for protocol patients. This is primarily attributable to social workers and volunteers focusing on the issue of transportation, to the respect given the patients and families, and to the families' involvement in the clinical care and research program.

北卡罗来纳州目前有两个儿科艾滋病临床 试验单位。 自一月份起，杜克大学就已设立了完整的儿科 ACTU 1987 年，作为成人/儿童混合艾滋病项目的一部分提供资金 治疗评估单位直至 1989 年。北卡罗来纳大学 教堂山医院的儿科部门一直在给孩子们看病 自 1990 年以来成人 ACTU。附属于 UNC 亚单位是一个小型 北卡罗来纳州夏洛特卡罗莱纳医疗中心的围产期计划。 我们 建议合并这三个地点和布伦纳的另外两个单位 温斯顿塞勒姆儿童医院和东卡罗来纳大学 格林维尔医学院，纳入一个统一的项目，北部 卡罗莱纳州儿童艾滋病网络 (NC-CAN)。 所有五个站点都将 能够将儿童纳入 ACTG 儿科方案，并且 4 这 5 个机构将让儿童参加围产期研究（ECU 不会）。 这 这些计划的统一将达到以下几个目的： 1) 访问 ACTG 协议将得到改进。 北卡罗来纳州排名第十 国家的人口，但其公民和感染艾滋病毒的儿童 城市和农村地区平均分配。 这5个站点分别是 地理分布且接近 HIV 血清流行率最高的地区 该州的地区。 2) 该州所有医学院都将 统一工作，减少竞争 允许更有效地利用资源。 此外， 来自全州的医学生和居民将接触到 儿童艾滋病毒问题日益严重，并接受培训以提供护理 这些困难的病人。 3）5个机构的研究能力 可以汇集并应用于临界数量的患者 注册 NC-CAN 系统。 4) NC-CAN 将为 在农村环境中提供基于研究的护理。 东南部有 世界上异性性传播艾滋病病例最多的国家 美国和北卡罗来纳州女性中的艾滋病毒血清流行率 正在迅速升级。 NC-CAN 将演示执行方法 此类人群的临床研究随后将 适用于疫情蔓延至其他非城市地区的情况 国家。 作为该计划当前成功的一个例子，尽管 事实上，患者单程平均旅行时间超过 90 分钟 前往杜克大学和北卡罗来纳大学，诊所的协议显示率为 88% 患者。 这主要归功于社会工作者和 志愿者关注交通问题，给予尊重 患者和家属以及家属参与治疗的情况 临床护理和研究计划。