Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

NCT ID: NCT00296153

Last Updated: 2008-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-10-31

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.

Conditions

Human Immunodeficiency Virus; Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Omacor 1000mg x 4 / day

Group Type: ACTIVE_COMPARATOR

Omega-3-acid ethyl esters 90

Intervention Type: DRUG

Omacor capsule 1000mg x 4 per day. Duration 12 weeks

2

Group Type: PLACEBO_COMPARATOR

Omega-3-acid ethyl esters 90

Intervention Type: DRUG

Omacor capsule 1000mg x 4 per day. Duration 12 weeks

Interventions

Omega-3-acid ethyl esters 90

Omacor capsule 1000mg x 4 per day. Duration 12 weeks

Intervention Type: DRUG

Other Intervention Names

Omacor versus placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Pronova BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Pronova BioPharma

Principal Investigators

Jeppe H. Christensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg Hospital, Department of Nephrology

Locations

Aalborg Hospital, Department of Nephrology

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

Eudract no: 2005-005135-10

Identifier Type: -

Identifier Source: secondary_id

CTN K85 05026

Identifier Type: -

Identifier Source: org_study_id