The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir
研究概览
简要总结
The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.
详细描述
Thirty patients with HIV infection will be enrolled in this open-label, parallel arm pharmacokinetic study. Subjects receiving either lopinavir/ritonavir or atazanavir/ritonavir as part of their antiretroviral therapy will have a pharmacokinetic study performed over 12-20 days to examine whether coadministration of lopinavir and atazanavir alters the pharmacokinetics of either agent. The safety of these agents in combination will also be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-seropositive
- •Currently receiving atazanavir/ritonavir or lopinavir/ritonavir in combination with 2-3 nucleoside RT inhibitors or are antiretroviral treatment-naïve
- •If female, is not of childbearing potential or is of childbearing potential and agrees to use a barrier method of contraception throughout the study
排除标准
- •HIV-1 RNA > 400 copies/mL if currently receiving antiretroviral therapy
- •Concurrent use of CYP450 inhibitors or inducers
- •Concurrent use of P-glycoprotein substrates, inhibitors, or inducers
- •Concurrent use of medications known to interact with ritonavir or atazanavir
- •Presence of a chronic health condition deemed by the investigators to potentially impair lopinavir, ritonavir, or atazanavir pharmacokinetics
- •Presence of conduction abnormalities on electrocardiogram
- •Women who are pregnant or breastfeeding
- •Laboratory Abnormalities at baseline:
- •Aminotransferases > 3x ULN
- •Serum bilirubin > 5x ULN
- •Serum creatinine > 1.5x ULN
- •Hemoglobin concentration < 8.0 g/dL
- •Absolute neutrophil count < 800 cells/μL
- •Platelet count < 50,000 cells/μL
研究组 & 干预措施
Arm A
Subjects on atazanavir/ritonavir will add lopinavir/ritonavir.
干预措施: lopinavir/ritonavir (Drug)
Arm B
Subjects on lopinavir/ritonavir will add atazanavir.
干预措施: atazanavir (Drug)
结局指标
主要结局
Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir
时间窗: Day 6, Day 12 or 16, Day 20
次要结局
- Safety (e.g., GI tolerance, lab abnormalities, ECG changes)(Day 6, Day 12 or Day 16, Day 20)