Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 30
- 主要终点
- Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule.
The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, 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
研究组 & 干预措施
TPV/r 290/115 mg/m^2
TPV and RTV oral solution low dose
干预措施: TPV oral solution (Drug)
TPV/r 290/115 mg/m^2
TPV and RTV oral solution low dose
干预措施: RTV oral solution (Drug)
TPV/r 375/150 mg/m^2
TPV and RTV oral solution high dose
干预措施: TPV oral solution (Drug)
TPV/r 375/150 mg/m^2
TPV and RTV oral solution high dose
干预措施: RTV oral solution (Drug)
结局指标
主要结局
Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation
时间窗: up to 288 weeks
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation
时间窗: up to 288 weeks
Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.
次要结局
- Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)(baseline, week 24)
- Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)(baseline, week 48)
- Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)(baseline, week 100)
- Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)(baseline, week 24)
- Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)(baseline, week 48)
- Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)(baseline, week 100)
- Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)(baseline, week 48)
- Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)(baseline, week 100)
- Baseline Median CD4+ Cell Count (Cells/mm3)(baseline)
- Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)(baseline, week 24)
- Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)(baseline, week 48)
- Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)(baseline, week 24)
- Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)(baseline, week 48)
- Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)(baseline, week 100)
- Baseline Median Viral Load log10 Copies/mL(baseline)
- Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)(baseline, week 24)
- Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)(baseline, week 100)
- Median Baseline CD4 Percent(baseline)
- Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)(baseline, week 24)
- Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)(baseline, week 48)
- Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)(baseline, week 100)
- Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8(week 8)
- Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16(week 16)
- Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24(week 24)
- Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48(week 48)