NCT01139905已完成2 期
Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children
The HIV Netherlands Australia Thailand Research Collaboration2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年4月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)
研究概览
简要总结
To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.
详细描述
This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection
- •Age < 18 years old
- •BW > 25 kg
- •HIV RNA viral load < 50 copies within 6 months
- •Written informed consent
排除标准
- •Active opportunistic infection
- •Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- •Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir
结局指标
主要结局
assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)
时间窗: 4 months
study drug Aluvia (lopinavir/ritonavir 100/25 mg)
次要结局
未报告次要终点
研究者
研究点 (2)
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