See Detailed Description.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24
研究概览
简要总结
This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.
详细描述
A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD)
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
FPV/r200
Fosamprenavir/ritonavir (either 700/100mg BID or 1400/200mg QD)
干预措施: Full Boosted Fosamprenavir (Drug)
FPV/r100
Fosamprenavir/ritonavir 1400/100mg QD
干预措施: Half-boosted Fosamprenavir (Drug)
结局指标
主要结局
Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24
时间窗: Week 24
Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.
次要结局
- Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis(Week 24)
- Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis(Week 24)
- Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis(Baseline and Week 24)
- Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis(Baseline and Week 24)
- Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24(Baseline through Week 24)
- Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24(Baseline through Week 24)
- Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24(Baseline and Week 24)
- Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24(Baseline and Week 24)
- Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline(Baseline through Week 24)
- Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24(Weeks 12 and 24)