ACTG 274--PHASE I STUDY OF COMBINATION THERAPY WITH DDI AND RIBAVIRIN IN CHILD

ACTG 274——儿童 DDI 和利巴韦林联合治疗的 I 期研究

• 批准号: 6282242
• 负责人: RUSSELL B. VAN DYKE
• 金额: $ 1.97万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1999-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6282242
• 关键词: 2'3' dideoxyinosine; AIDS therapy; child (0-11); clinical research; clinical trial phase I; combination chemotherapy; drug screening /evaluation; human subject; human therapy evaluation; pediatric AIDS; pediatric pharmacology; pharmacokinetics; ribavirin

ACTG 274: When used as initial monotherapy, as well as following initial therapy with ZDV, ddI has been shown to be an effective anti-HIV agent. The addition of ribavirin, while possessing only limited anti-HIV activity on its own, potentiates the antiretroviral activity of DDI by enhancing the intracellular metabolism of ddI. While the active form of DDI is increased in the body through this mechanism, DDI related toxicities do not appear to increase, and the pharmacokinetic profile of ddI remains basically unchanged. The primary objectives of this two cohort protocol are to determine the safety, tolerance and pharmacokinetics of ddI when administered with ribavirin in HIV infected children ages three months to 12 years.

ACTG 274：用作初始单一治疗时，以及以下初始治疗 用ZDV治疗，DDI已被证明是一种有效的抗HIV药物。 添加利巴韦林，同时仅具有有限的抗艾滋病毒 自身的活性，通过以下方式增强DDI的抗逆转录病毒活性 增强DDI的细胞内代谢。而主动形式的 DDI是通过这种机制在体内增加的，与DDI相关 毒性似乎没有增加，而且 DDI基本保持不变。这两个项目的主要目标是 队列方案是为了确定安全性、耐受性和 利巴韦林治疗HIV时DDI的药代动力学 受感染的儿童年龄在3个月到12岁之间。