Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

• the change from week 0 (baseline) to week 12 for
• - Plasma triglycerides

• The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation [ Time Frame: baseline and 12 weeks ]
• HDL-cholesterol, LDL-cholesterol, total cholesterol [ Time Frame: baseline and 12 weeks ]
• Inflammatory parameters: ICAM, VCAM, sensitive CRP [ Time Frame: 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 [ Time Frame: baseline and 12 weeks ]
• Safety parameters [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]

• The change from week 0 (baseline) to week 12 for
• -Pulse Wave Velocity, Flow medicated vasodilation
• - HDL-cholesterol, LDL-cholesterol, total cholesterol
• - Inflammatory paratmeters: ICAM, VCAM, sensitive CRP
• - Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Facot, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes
• - Safety parameters.

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)

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:

1. the immunodeficient effects of the HIV infection itself may influence the progression of arteriosclerosis
2. the higher levels of risk behaviour in this group of patients (i.e. high prevalence of smokers in this group)
3. 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.

• Human Immunodeficiency Virus
• Ischemic Heart Disease

• Active Comparator: 1
  Omacor 1000mg x 4 / day
  Intervention: Drug: Omega-3-acid ethyl esters 90
• Placebo Comparator: 2
  Intervention: Drug: Omega-3-acid ethyl esters 90

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