NCT00819052已完成3 期
An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 39
- 主要终点
- Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
研究概览
简要总结
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.
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
- 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
研究组 & 干预措施
NVP IR
Active Comparator
200 mg orally twice a day (po BID)
干预措施: Nevirapine XR (Drug)
NVP IR
Active Comparator
200 mg orally twice a day (po BID)
干预措施: Nevirapine IR (Drug)
NVP XR
Experimental
400 mg orally once a day (po QD)
干预措施: Nevirapine XR (Drug)
结局指标
主要结局
Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
时间窗: week 24
Primary endpoint was the number of patients with a sustained virologic response through week 24
次要结局
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population(baseline, week 2)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population(baseline, week 24)
- Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population(baseline, week 24)
- Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population(last available visit, up to 144 weeks)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population(baseline, week 48)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population(baseline, week 60)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population(baseline, week 108)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population(baseline, week 144)
- Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144(week 144)
- Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population(week 24)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population(baseline, week 4)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population(baseline, week 84)
- Trough Plasma Concentration(Day 1 to week 48)
- Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population(week 0)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population(baseline, week 96)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population(baseline, last available visit (up to 144 weeks))
- Change From Baseline in VL (HIV-1 Viral Load) at Each Visit(week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit)
- Changes in Safety Parameters Related to Treatment(until week 144)
- Occurence of Rashes(144 weeks)
- Time to Loss of Virologic Response(48 weeks)
- Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population(week 0 to 24)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population(baseline, week 12)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population(baseline, week 72)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population(baseline, week 120)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population(baseline, week 132)
- Genotypic Resistance Associated With Virologic Failure(48 weeks)
- Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population(baseline, week 8)
- Occurence of Hepatic Events(144 weeks)
- New AIDS or AIDS-related Progression Event or Death(144 weeks)
研究者
研究点 (39)
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