NCT00598910终止4 期
A Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Investigate the Effect of Omacor (n-3 PUFA) on Lipid Parameters in HIV Infected Subjects Treated With HAART
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 5
- 主要终点
- Percent change in serum triglycerides from baseline to treatment endpoint versus placebo
研究概览
简要总结
Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment
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
- Double (Participant, Investigator)
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
- •Triglycerides between 200 and 800
- •diagnosed HIV infection
- •following HAART therapy
排除标准
- •other malignant disease
- •not compliant
- •allergy against fish oil
- •soy or olive oil
研究组 & 干预措施
A
Experimental
干预措施: Omacor (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo
时间窗: 12 weeks treatment
次要结局
- Absolute change in serum triglycerides(12 weeks)
- Absolute and percent change in cholesterol and cholesterol subfractions(12 weeks)
- Absolute and percent change in apolipoprotein A and B(12 weeks)
研究者
研究点 (5)
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