NCT00643968已完成4 期
Randomized Multicenter Open-Label, Pilot Trial to Evaluate the Efficacy and Safety of Switching HIV-1 Stable Infected Patients Under HAART to a New Once Daily Triple Therapy Combination Including EFV+3TC+TDF Versus a Dual QD Therapy Containing EFV+TDF
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)
研究概览
简要总结
Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)
Main Secondary objectives:
Comparison of the two arms for genotypic resistance profile in case of virological failure
CD4 changes from baseline
Evolution of the lipid profile and morphological changes in fat distribution, and safety
Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable HAART ≥ 3 months
- •HIV-1 RNA < 50 c/mL ≥ 6 months
- •No HAART failure history
排除标准
- •Weight > 45 kg
- •No CD4+ cell count criteria
- •No significant laboratory or clinical abnormalities
- •Creatinine Clearance > 60 mL/min
研究组 & 干预措施
1
Active Comparator
TDF+EFV
干预措施: EFV+TDF (Drug)
2
Experimental
TDF+3TC+EFV
干预措施: EFV+3TC+TDF (Drug)
结局指标
主要结局
Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)
时间窗: 48 wks
次要结局
- Comparison of the two arms for genotypic resistance profile in case of virological failure(48 wks)
- CD4 changes from baseline(48 wks)
- Evolution of the lipid profile and morphological changes in fat distribution, and safety(48 wks)
研究者
研究点 (1)
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