NCT02191202已完成不适用
Observational Study of the Impact on Quality-of-life of a Switch From a Virologically Effective Regimen to a Regimen Containing a Non-Nucleoside Reverse Transcriptase Inhibitor (QUALVI) Nevirapine (Viramune®) Clinical Phase IV
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
- 283
- 主要终点
- Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score
研究概览
简要总结
Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NNRTI-naive patients with positive HIV serology, treated with at least triple combination therapy, with a viral load < 500 copies/ml, in whom a new treatment comprising an NNRTI is initiated for a reason other than inefficacy of treatment will be included
- •Patients must read and write French
排除标准
- •Patients in whom a new treatment is initiated because of treatment failure
- •new treatment does not comprise an NNRTI
研究组 & 干预措施
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
干预措施: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) (Drug)
结局指标
主要结局
Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score
时间窗: Baseline, month 1, 6 and 12
次要结局
- Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population(Baseline, 12 months)
- Changes in liver function tests(Baseline and month 3, 6, 9, 12)
- Changes in total cholesterol(Baseline, month 6 and 12)
- Changes in triglycerides(Baseline, month 6 and 12)
- Changes in fasting blood glucose(Baseline, month 6 and 12)
- Changes in haemoglobin(Baseline, month 6 and 12)
- Changes from baseline in plasma urea(Baseline, month 12)
- Changes from baseline in creatinine(Baseline, month 12)
- Changes in symptom scale score(Baseline, month 1, 6 and 12)
- Changes in Hospital Anxiety and Depression scale (HADS)(Baseline, month 1, 6 and 12)
- Changes in cluster of differentiation 4 (CD4) cell count(Baseline and month 3, 6, 9, 12)
- Changes in viral load(Baseline and month 3, 6, 9, 12)
研究者
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