NCT00365612已完成4 期
Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on Their HAART Regimen
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 56
- 主要终点
- Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48
研究概览
简要总结
To compare the effectiveness (efficacy, safety & tolerability) of a Single Tablet Regimen of efavirenz/emtricitabine/tenofovir DF to subjects continuing on unmodified HAART as measured by the proportion of patients who maintain viral load (HIV-1 RNA) <200 copies/mL at Week 48.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 positive patients who have maintained an HIV-1 viral load <200 copies/mL, for at least 3 months.
- •Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
- •HAART must consist of either:
- •A PI (with or without ritonavir) + at least 2 NRTIs or
- •An NNRTI + at least 2 NRTIs.
- •Negative serum pregnancy test.
排除标准
- •Patients who have taken any NNRTI prior to their current therapy.
- •Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.
- •Patients who are currently taking EFV+FTC+TDF.
- •Patients who have a creatinine clearance of <60 mL/min by Cockcroft-Gault estimation.
- •Patients who have experienced virologic failure with any previous ARV therapy.
- •Patients who have documented resistance to any of the study agents at any time in the past.
结局指标
主要结局
Primary: Proportion of patients with HIV-1 RNA levels <200 copies/mL at Week 48
Safety Outcome Measures: Adverse Events, Laboratory Tests
Outcomes Research Measures: Quality of life, adherence, preference of medication, perceived ease of regimen, HIV symptoms
次要结局
未报告次要终点
研究者
研究点 (56)
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