BALTIMORE PEDIATRIC AIDS CLINICAL TRIALS GROUP

该应用程序是对NIH-NIAID RFA扩展的回应 儿科艾滋病临床试验组（ACT）通过资助 与多家儿科中心达成合作协议。 我们提出 建立一个单一的、协作的儿科ACT中心， 约翰霍普金斯大学医学院和 马里兰州，这两个机构遵循的绝大多数 接触人类免疫缺陷病毒（艾滋病毒）感染的儿童 在巴尔的摩市。 合并后的机构 约132名感染艾滋病毒的儿童， 感染艾滋病毒的母亲所生的孩子。 活动计划存在于 每个为接触艾滋病毒的儿童提供初级保健的机构 感染和每个程序都致力于临床调查 儿科艾滋病感染的几个方面。 此外，阶段 齐多夫定用于有症状的艾滋病毒感染儿童的II期试验 感染正在约翰霍普金斯医院进行， 研究齐多夫定的药代动力学和安全性的方案 新生儿开始了。 这项合作将临床研究人员与 儿科感染性疾病，儿科免疫学， 初级保健儿科、产科、艾滋病毒实验室诊断 感染和临床药理学。 其中一些调查员 在研究设计、项目管理、 协调、数据管理和生物统计。 额外工作人员 将包括儿科医生，社会工作者， 实验室人员。 巴尔的摩儿科法案希望参与这些 由协作儿科ACT生成的协议， 可以为整体努力做出贡献， 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剂，免疫调节剂， 治疗和药物管理的机会性感染 与小儿艾滋病有关。 我们还预计， 艾滋病临床试验组的领导作用， 领域，特别是抗病毒药物和其他 可能改变或预防HIV感染的治疗方式 在新生儿中。 这一目标补充了我们正在进行的 研究了垂直运输的机理和风险因素 艾滋病毒的传播。

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.