NCT00648999已完成4 期
Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
AbbVie (prior sponsor, Abbott)13 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2003年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 13
- 主要终点
- Quality of Life
研究概览
简要总结
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV Infected subjects
- •Subjects failing in current HIV treatment, or
- •Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.
排除标准
- •Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
- •Subject is pregnant
研究组 & 干预措施
1
Active Comparator
干预措施: lopinavir/ritonavir (Drug)
2
Active Comparator
干预措施: lopinavir/ritonavir (Drug)
结局指标
主要结局
Quality of Life
时间窗: Baseline, Week 4, Week 24 and Week 48
CD4
时间窗: Baseline, Week 24 and Week 48
次要结局
- Adverse Event Monitoring(Baseline, Week 4, Week 24 and Week 48)
研究者
研究点 (13)
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