Preliminary Study of Safety and Efficacy of Policosanol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- LDL Cholesterol
研究概览
简要总结
Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that policosanol will lower levels of LDL cholesterol ("bad" cholesterol) and raise levels of HDL cholesterol ("good" cholesterol).
详细描述
As per Brief Summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD4 count > 250 Plasma HIV RNA < 50,000 Currently receiving HAART age 18-60 total cholesterol between 200-240 or triglycerides between 150-400 or LDL cholesterol > 160
排除标准
- •kidney or liver disease current use of lipid-lowering drugs pregnancy lactation
研究组 & 干预措施
Policosanol
20 mg daily of policosanol
干预措施: Policosanol (Drug)
Placebo
20 mg of microcrystalline cellulose daily
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
LDL Cholesterol
时间窗: 12 weeks
Low density lipoprotein cholesterol
次要结局
- Triglycerides(12 weeks)
研究者
Barbara Swanson
Assistant Professor
Rush University Medical Center