NCT00056641已完成2 期
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.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 109
- 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
- •Signed informed consent prior to trial participation.
- •Human Immunodeficiency Virus type 1 (HIV-1) infected males or females ≥18 years of age.
- •Acceptable laboratory screening values in Trial 1182.12 (RESIST 1) or 1182.48 (RESIST 2), excluding genotype.
- •Genotypic resistance report from screening visit of study RESIST 1 or RESIST 2 indicating at least three mutations at protease codons 33, 82, 84, and
- •At least 3 consecutive months experience taking ARVs from each of the classes of Nucleoside reverse transcriptase inhibitors (NRTI), Non-nucleoside reverse transcriptase inhibitor 1 (NNRTI), and Protease Inhibitor (PI) at some point in treatment history, with at least 2 PI-based regimens, one of which must be part of the current regimen, and current PI-based Anti-retroviral (ARV) medication regimen for at least 3 months prior to randomization.
- •HIV-1 viral load ≥1000 copies/mL at screening.
- •Further inclusion criteria apply.
排除标准
- •Anti-retroviral (ARV) medication naïve.
- •Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months.
- •Female patients of child-bearing potential who:
- •have a positive serum pregnancy test at screening or during the study,
- •are breast feeding,
- •are planning to become pregnant,
- •are not willing to a use barrier method of contraception, or
- •require ethinyl estradiol administration.
- •Prior tipranavir use.
- •Use of investigational medications within 30 days before study entry or during the trial.
- •Further exclusion criteria apply.
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)
研究者
研究点 (109)
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