Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Baseline Mean Serum Triglyceride Level at Study End
研究概览
简要总结
The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.
详细描述
This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, with 12-week treatment periods separated by a 4-week washout. This study will be conducted at the Clinical Research Center at Tufts Medical Center.
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
- •HIV-infected men and women at least 18 years of age
- •On stable HAART for previous three months and without anticipated changes in their HAART regimen throughout the duration of the study
- •Fasting triglycerides > 150 mg/dl and < 1,500 mg/dl
- •Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changes during the course of the study
- •Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on the study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke
- •Female participants of reproductive age must not be pregnant (negative test) or lactating at screening and throughout the trial and agree to use 2 methods of barrier contraception for the course of the trial and 2 months after the trial unless they are surgically sterilized (tubal ligation or hysterectomy), or post-menopausal with no menses for > 1 year
- •Ability to provide consent
排除标准
- •Plasma HIV-1 RNA > 10,000
- •Previous history of atherosclerotic disease or diabetes mellitus
- •Change in HAART regimen over three months prior to study entry
- •Change in lipid lowering therapy within 2 months
- •On chronic anticoagulants such as heparin or coumadin
- •On fish oil, omega 3 supplements, or Omacor currently or during the past month
研究组 & 干预措施
Placebo
Placebo, dietary counseling
干预措施: Placebo (Drug)
Lovaza
Lovaza, dietary counseling
干预措施: Lovaza (Drug)
结局指标
主要结局
Change in Baseline Mean Serum Triglyceride Level at Study End
时间窗: Baseline and 12 weeks
Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo
次要结局
- Brachial Artery Reactivity(12 weeks)
- Serum HDL Level(12 weeks)