NCT00466180已完成4 期
Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- MEMS adherence by electronic devices
研究概览
简要总结
Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day.
We hypothesized that once-daily dosing improves adherence.
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
- •HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months
- •plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions
- •accept adherence electronic monitoring
- •written informed consent signed
排除标准
- •asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
- •AST or ALT>1.25N if hepatitis virus B or C were positive
结局指标
主要结局
MEMS adherence by electronic devices
时间窗: 28-week period (randomized phase)
次要结局
- Virologic efficacy (RNA HIV<400cp/ml)
- Immunologic efficacy (CD4 count cells)
- Tolerance (hepatic, cutaneous, ANRS safety grade scale)
- Pharmacokinetics (nevirapine dosages)
研究者
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