A Multicenter Randomized Study to Compare the Safety and Efficacy of Low-dose Versus Standard Dose Lopinavir/Ritonavir Containing HAART Regimen in Virological Suppressed HIV-infected Thai Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 10
- 主要终点
- To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week
研究概览
简要总结
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection children age < 18 years old
- •Currently on PI regimens
- •HIV RNA viral load < 50 copies/ml at screening
- •BW 25-50 kg
- •Written informed consent
排除标准
- •Relevant history or current condition of PI resistance, plasma HIV RNA > 1000 copies/ml after received the PI regimens for at least 6 months
- •On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir
- •On double boosted protease inhibitors
研究组 & 干预措施
standard dose
Arm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW >35-50 kg 400/100 mg
干预措施: kaletra (Drug)
low dose
Arm 2:Low dose BW 25-35 kg 200/50 mg BW >35-50 kg 300/75 mg
干预措施: kaletra (Drug)
结局指标
主要结局
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week
时间窗: 48 week
proportion of patient who had HIV RNA \< 50 copies/ml Safety issue: patient who had HIV RNA \> 50 copies/ml during the study period will be checked for LPV blood level, if the LPV Cmin \< 1 ug/ml. The dose of LPV/r will be adjusted to appropriate dose.
次要结局
未报告次要终点