NCT02191332已完成不适用
Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 主要终点
- Change in viral load (HIV-RNA)
研究概览
简要总结
Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult male or female patients with HIV type 1 infection
排除标准
- •Counter-indications according to summary of product characteristics (SPC) for Viramune tablets
- •No persons under 18
- •Pregnancy and breast-feeding
- •Use of oral contraceptives
- •Use of drugs affecting CYP450 3A metabolism
研究组 & 干预措施
Viramune
干预措施: Viramune (Drug)
结局指标
主要结局
Change in viral load (HIV-RNA)
时间窗: Baseline, after 26 and 52 weeks
Change in CD4 cell count
时间窗: Baseline, after 26 and 52 weeks
Change in glucose tolerance
时间窗: Baseline, after 26 and 52 weeks
verbal rating scale
Change in lipid status (lipodystrophy, triglycerides, cholesterol)
时间窗: Baseline, after 26 and 52 weeks
verbal rating scale
次要结局
- Assessment of tolerability by physician and patient(after 26 and 52 weeks)
- Number of patients with adverse events(up to 52 weeks)
- Assessment of subjective well-being(up to 52 weeks)
研究者
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