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

ACTG 274：当用作初始单药治疗时，以及在初始 在ZDV治疗中，ddI已被证明是一种有效的抗HIV药物。 而加入利巴韦林后，仅具有有限的抗艾滋病病毒作用 活性本身，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。 虽然积极形式的 DDI通过这种机制在体内增加，DDI相关 毒性似乎没有增加， ddI基本保持不变。这两个主要目标 队列方案旨在确定安全性、耐受性和 在HIV患者中，当与利巴韦林联合给药时，ddI的药代动力学 受感染的儿童年龄在3个月到12岁之间。

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.