BALTIMORE PEDIATRIC AIDS CLINICAL TRIALS GROUP

巴尔的摩儿科艾滋病临床试验组

• 批准号: 3547344
• 负责人: JOHN F. MODLIN
• 金额: $ 64.73万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-09-30 至 1993-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3547344
• 关键词: AIDS; AIDS /HIV test; AIDS therapy; Retroviridae disease; antigen antibody reaction; antiviral agents; child (0-11); communicable disease transmission; disease /disorder proneness /risk; drug adverse effect; embryo /fetus; enzyme linked immunosorbent assay; gel electrophoresis; human immunodeficiency virus; human subject; human therapy evaluation; immunomodulators; infant human (0-1 year); interferons; pediatrics; secondary infection; zidovudine

This application is a response to the NIH-NIAID RFA for Expansion of the Pediatric AIDS Clinical Trials Group (ACT) via funding of cooperative agreements with several pediatric centers. We propose to develop a single, collaborative pediatric ACT center at the Johns Hopkins University School of Medicine and the University of Maryland, the two institutions that follow the great majority of children exposed to human immunodeficiency virus (HIV) infection within the City of Baltimore. The combined institutions have experience with approximately 132 children with HIV infection or children born to HIV infected mothers. Active programs exist at each institution for primary care of children exposed to HIV infection and each program is committed to clinical investigation of several aspects of pediatric HIV infection. In addition, Phase II trials of zidovudine use in children with symptomatic HIV infection are just underway at Johns Hopkins, and a Phase I protocol to study the pharmacokinetics and safety of zidovudine in newborn infants will begin soon. This collaboration brings together clinical investigators with expertise in pediatric infectious diseases, pediatric immunology, primary care pediatrics, obstetrics, laboratory diagnosis of HIV infections, and clinical pharmacology. Some of these investigators also have considerable experience in study design, project coordination, data management, and biostatistics. Additional staff will include pediatric practitioners, social workers, and laboratory personnel. The Baltimore Pediatric ACT expects to participate in those protocols generated by the Collaborative Pediatric ACT in which we can make a contribution to the overall effort and which are compatible with our own treatment and research objectives. This includes the study of specific antiviral agents, immunomodulating therapy, and drugs for management of the opportunistic infections associated with pediatric AIDS. We also expect to assume a leadership role without the AIDS Clinical Trials Group in certain areas, particularly the study of antiviral agents and other therapeutic modalities that might modify or prevent HIV infection in newborn infants. This objective complements our ongoing research into the mechanism and risk factors for vertical transmission of HIV.

此应用程序是对NIH-NIAID RFA扩展的响应 儿科艾滋病临床试验小组(ACT)通过资助 与几个儿科中心达成合作协议。我们建议 开发一个单一的、协作的儿科ACT中心 约翰霍普金斯大学医学院和华盛顿大学 马里兰州，这两个机构遵循了绝大多数 暴露于人类免疫缺陷病毒(HIV)感染的儿童 在巴尔的摩市内。合并后的机构有 约132名感染艾滋病毒或感染艾滋病毒的儿童的经验 感染艾滋病毒的母亲所生的孩子。活动计划存在于 为感染艾滋病毒的儿童提供初级保健的每个机构 感染，每个项目都致力于临床研究 儿童艾滋病毒感染的几个方面。此外，阶段 II齐多夫定用于有症状的艾滋病毒儿童的试验 约翰·霍普金斯大学的感染刚刚开始，第一阶段 齐多夫定在人体内的药代动力学和安全性研究方案 新生儿马上就要出生了。 这种协作将临床研究人员与 在儿科传染病、儿科免疫学、 初级保健儿科、产科、艾滋病毒的实验室诊断 感染和临床药理学。其中一些调查人员 在书房设计、项目等方面也有相当的经验 协调、数据管理和生物统计。增加员工人数 将包括儿科医生、社会工作者和 实验室人员。 巴尔的摩儿科ACT预计将参加这些 由协作儿科ACT生成的协议，其中我们 可以对总体努力做出贡献，这些是 符合我们自己的治疗和研究目标。这 包括研究特定的抗病毒药物、免疫调节 治疗和治疗机会性感染的药物 与儿童艾滋病有关。我们还期望假设一个 没有艾滋病临床试验小组的领导作用 领域，特别是抗病毒药物的研究和其他 可能改变或预防艾滋病毒感染的治疗方式 在新生婴儿身上。这一目标是对我们正在进行的 垂直向倾斜的机理及风险因素研究 艾滋病毒的传播。