Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pronova BioPharma
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital

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