An Open Label, Randomized, Parallel-group Pharmacokinetics Trial of Tipranavir / Ritonavir (TPV/RTV), Alone or in Combination With RTV-boosted Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV), Plus an Optimized Background Regimen, in Multiple Antiretroviral (ARV) Experienced Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 128
- 主要终点
- Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h)
研究概览
简要总结
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.
The primary objective is to determine the safety and pharmacokinetics of:
TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h)
时间窗: Day 14 to Day 28
Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs
时间窗: week 4
次要结局
- Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group)(Week 1 and 2)
- Assessment of patient adherence(Week 1 to 4)
- Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group)(Week 3 and 4)
- Change in AUC(0-12h) of RTV from week 2; Change in Cmax of RTV from week 2; Change in C12h of RTV from week 2(week 4)
- AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV(week 2 and 4)
- Change in viral load; Proportion of virologic responders(week 2, 4, 8, 16 and 24)
- Change in AUC(0-12h) of TPV from week 2; Change in Cmax of TPV from week 2; Change in C12h of TPV from week 2(week 4)
- Area under the Curve (AUC(0-12h)) of the 2nd PI (APV, LPV. SQV); Maximum concentration (Cmax) of the 2nd PI (APV, LPV. SQV); Concentration (C12h) of the 2nd PI (APV, LPV. SQV)(week 2 and 4)