Comparison of two indinavir/ritonavir regimens in the treatment of HIV-infected individuals
Comparison of two indinavir/ritonavir regimens in the treatment of HIV-infected individuals
复制标题
DOI：
10.1097/00126334-200411010-00004
复制
发表时间：
2004-11-01
影响因子：
3.6
通讯作者：
Gerber, JG
中科院分区：
文献类型：
--
作者：
Acosta, EP;Wu, HL;Gerber, JG
背景：低剂量利托那韦（RTV）用于挽救治疗的蛋白酶抑制剂（PI）的药代动力学增强越来越常见。本研究的目的是比较茚地那韦（IDV）/RTV的药代动力学，安全性和耐受性，在800/200毫克（A组）和400/400毫克（臂B），每天两次给药的HIV感染的受试者失败的第一PI为基础的regiments.Methods：一个阶段I/II，随机，开放标签，24周的研究进行。进行正式的12小时药代动力学评价，并在基线时、第1、2和4周以及此后每4周一次进行研究访视，持续24周。收集临床症状和实验室评估。受试者被允许切换武器，因为toxicity.Results：44例受试者入组（每组22）。A组的IDV给药前浓度、最大血浆浓度和曲线下面积显著较高。A组和B组分别有55%和45%的受试者有应答（
Background: Pharmacokinetic enhancement of protease inhibitors (PIs) with low-dose ritonavir (RTV) for salvage therapy is increasingly common. The purpose of this study was to compare the pharmacokinetics, safety, and tolerability of indinavir (IDV)/RTV at 800/200 mg (arm A) and 400/400 mg (arm B) administered twice daily in HIV-infected subjects failing their first PI-based regimen.Methods: A phase I/II, randomized, open-label, 24-week study was conducted. Formal 12-hour pharmacokinetic evaluations were performed, and study visits occurred at baseline; at weeks 1, 2, and 4; and every 4 week thereafter for 24 weeks. Clinical symptoms and laboratory assessments were collected. Subjects were allowed to switch arms because of toxicity.Results: Forty-four subjects were enrolled (22 per arm). IDV predose concentration, maximum plasma concentration and area under the curve were significantly higher in arm A. Fifty-five percent and 45% of subjects in arms A and B responded (