Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Flow Mediated Dilation (FMD) of the Brachial Artery
研究概览
简要总结
Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-70
- •HIV-1 RNA <400 copies/ml.
- •On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos.
排除标准
- •Active infection
- •Inflammation or malignancy
- •Uncontrolled diabetes or hypothyroidism
- •LDL (low density lipoprotein) cholesterol >160 and triglyceride levels >750
- •Framingham risk score <6.
研究组 & 干预措施
Lovaza
Lovaza 1 gram by mouth twice a day for 24 weeks.
干预措施: Lovaza (Drug)
Placebo
Placebo capsule by mouth twice a day x 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Flow Mediated Dilation (FMD) of the Brachial Artery
时间窗: baseline and week 24
Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.
次要结局
未报告次要终点
研究者
Grace McComsey
Principal Investigator
University Hospitals Cleveland Medical Center