Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

Phase 4

Completed

• Conditions: Human Immunodeficiency Virus; Ischemic Heart Disease
• Interventions: Drug: Omega-3-acid ethyl esters 90

• Registration Number: NCT00296153
• Lead Sponsor: Pronova BioPharma

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-24
• Primary Completion: 2006-11
• Study Completion: 2007-10
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-10
• Last Update Posted: 2008-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Omega-3-acid ethyl esters 90	Omacor 1000mg x 4 / day
2	Omega-3-acid ethyl esters 90	-

Primary Outcome Measures

Name	Time	Method
The change from week 0 (baseline) to week 12 for: Plasma triglycerides	baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aalborg Hospital, Department of Nephrology; 🇩🇰 Aalborg, Denmark