Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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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

Conditions
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Human Immunodeficiency Virus, Ischemic Heart Disease

Intervention / Treatment
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* Drug: Omega-3-acid ethyl esters 90


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Omacor 1000mg x 4 / day | Drug: Omega-3-acid ethyl esters 90<br>* Omacor capsule 1000mg x 4 per day. Duration 12 weeks<br>* Other names: Omacor versus placebo;|
| Placebo Comparator: 2<br> | Drug: Omega-3-acid ethyl esters 90<br>* Omacor capsule 1000mg x 4 per day. Duration 12 weeks<br>* Other names: Omacor versus placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from week 0 (baseline) to week 12 for: Plasma triglycerides |  | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human immunodeficiency Virus (HIV), Highly Active Antiviral Therapy (HAART), Ischemic Heart Disease, OMACOR, Triglycerides, Endothelial function, Treatment Experienced