NCT02191293已完成不适用
Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 主要终点
- Changes in viral load (HIV-RNA)
研究概览
简要总结
Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.
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 and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)
- •Women can only be included, if a test has excluded pregnancy
- •Only women can be included, who use a reliable means of contraception during the observational study
排除标准
- •Known sensitivity to Viramune or one of its excipients
- •Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)
- •Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism
- •For females:
- •Pregnancy
- •Breast-feeding
- •Insufficient or unreliable contraception
研究组 & 干预措施
Viramune®
干预措施: Viramune® tablets (Drug)
结局指标
主要结局
Changes in viral load (HIV-RNA)
时间窗: Baseline, up to 36 months
Changes in CD4 cell count
时间窗: Baseline, up to 36 months
次要结局
- Changes in body weight(Baseline, up to 36 months)
- Changes in general well-being assessed on a 4-point scale(Baseline, up to 36 months)
- Changes in lipid parameters(Baseline, up to 36 months)
- Changes in glucose(Baseline, up to 36 months)
- Changes in liver enzymes(Baseline, up to 36 months)
- Number of patients with adverse events(up to 36 months)
研究者
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