PEDIATRIC AIDS TREATMENT GROUP

儿科艾滋病治疗小组

• 批准号: 3547260
• 负责人: CATHERINE M WILFERT
• 金额: $ 91.78万
• 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 1993-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3547260
• 关键词: AIDS; AIDS therapy; newborn human (0-6 weeks); pediatric AIDS; zidovudine

The Duke University Medical Center proposes to continue as the treatment and therapeutic evaluation center for children with human immunodeficiency virus Infection in North Carolina and adjacent referral areas. An increasing number of infected children are being recognized and effective therapeutic modalities for children are being developed and tested in Phase I, II & III protocols. The pharmacokinetics of zidovudine has been studied in children at Duke and the appropriate dosage will be utilized in a multi-institutional, open label trial to demonstrate efficacy in comparison to historical controls. Pharmacokinetics of ZDV and ultimately of other compounds will be determined in newborns. A placebo versus ZDV trial in infants born to seropositive women is planned as attempted intervention. Sequential evaluation of babies will provide data concerning prospective rate of acquisition of infection. Comparisons will be made of infected babies and uninfected infants who have been randomized to receive ZDV. Development, cardiomyopathy, neurological function, pulmonary function and development of HIV associated infections will be monitored. A specific research project is being designed to delineate the human B cell repertoire in neonate born to seropositive mothers. An established limiting dilution culture system of EBV infected B cells will be utilized to study the ontogeny and diversity of B cell repertoire. Several prototype antibody systems will be used to determine if the B cell repertoire of an infant with exposure to HIV develops normally. Recognition of cells secreting of HIV specific antibodies may provide a means of early neonatal diagnosis. Another means of early diagnosis will be an evaluation of specific HIV directed cytotoxicity. addition, careful observations will be made of the phenotypic appearance, and functional behavior of the immune system in treated and untreated newborns during their first year of life.

杜克大学医学中心建议继续治疗 人类免疫缺陷儿童治疗评估中心 北卡罗来纳州和邻近转诊地区的病毒感染。一个 越来越多的受感染儿童正在得到认识和有效 儿童治疗方式正在阶段性开发和测试 I、II 和 III 协议。齐多夫定的药代动力学已被研究 杜克大学的儿童中，适当的剂量将用于 多机构、开放标签试验以证明比较疗效 到历史控制。 ZDV 以及其他药物的药代动力学 化合物将在新生儿中进行测定。安慰剂与 ZDV 试验 计划对血清反应呈阳性的妇女所生的婴儿进行尝试干预。 对婴儿的连续评估将提供有关前瞻性的数据 获得感染率。将对感染者进行比较 随机接受 ZDV 的婴儿和未感染婴儿。 发育、心肌病、神经功能、肺功能和 将监测艾滋病毒相关感染的发展。具体的 研究项目旨在描绘人类 B 细胞库 血清反应呈阳性的母亲所生的新生儿。既定的有限稀释 EBV感染的B细胞培养系统将用于研究 B 细胞库的个体发育和多样性。几种原型抗体 系统将用于确定婴儿的 B 细胞库是否 接触 HIV 后发育正常。识别细胞分泌 HIV特异性抗体可能提供新生儿早期诊断的一种手段。 早期诊断的另一种方法是评估特定的艾滋病毒 定向细胞毒性。 此外，将对表型外观进行仔细观察， 以及治疗和未治疗的免疫系统的功能行为 新生儿在生命的第一年。