Omacor; Omega-3-Acid Ethyl Ester 90 (n-3 PUFA) and Risk Factors in HIV Infected Patients Treated With HAART, With Special Focus on Lipids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- The change from week 0 (baseline) to week 12 for: Plasma triglycerides
研究概览
简要总结
The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART)
详细描述
Results from recent studies show increasing numbers of Ischemic Heart Disease (IHD) incidents among patients on HAART treatment (Highly Active Antiviral Therapy). Three elements have received special attention:
- the immunodeficient effects of the HIV infection itself may influence the progression of arteriosclerosis
- the higher levels of risk behaviour in this group of patients (i.e. high prevalence of smokers in this group)
- The HAART treatment itself increases plasma levels of cholesterol, LDL cholesterol and triglycerides, resulting in HIV related lipodystrophy.
The cardioprotective effects of n-3 PUFAs are well established both through epidemiological studies and through small and large clinical trials. Clinical trials have shown positive effects of n-3 PUFA on plasma triglycerides, and statistically significant reductions in cardiovascular death and sudden cardiac death. Moreover n-3 PUFAs have been shown to have beneficial effects on endothelial function. Based on the above rationale it is expected that Omacor (Omega-3-acid ethyl ester 90) will have positive effects on risk factors related to Ischemic Heart Disease in HIV patients on HAART treatment.
Approximately 50 patients will be randomized to Omacor 4 grams/day or placebo. Treatment period is 12 weeks.
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
- •Man/women > 18 years of age
- •Documented HIV infection
- •On active treatment with HAART for at least 3 months.
- •Written informed consent. This implies that the patient can read and understand Danish or English
排除标准
- •Age < 18 years
- •Malign disease
- •Patients assessed as not cooperative
- •Patients planning to be pregnant or who are already pregnant or breast feeding.
- •Patients who have been taking fish oil capsules prior to randomization. However, patients who have discontinued fish oil supplements at least 8 weeks prior to the first visit will be included
- •Patients allergic to fish proteins
- •Statin treatment that has been ongoing for less than three months, or a change in statin treatment dose within the last three months
研究组 & 干预措施
1
Omacor 1000mg x 4 / day
干预措施: Omega-3-acid ethyl esters 90 (Drug)
2
干预措施: Omega-3-acid ethyl esters 90 (Drug)
结局指标
主要结局
The change from week 0 (baseline) to week 12 for: Plasma triglycerides
时间窗: baseline and 12 weeks
次要结局
- The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation(baseline and 12 weeks)
- HDL-cholesterol, LDL-cholesterol, total cholesterol(baseline and 12 weeks)
- Inflammatory parameters: ICAM, VCAM, sensitive CRP(baseline and 12 weeks)
- Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Factor, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes(baseline and 12 weeks)
- Safety parameters(baseline and 12 weeks)