Status:
COMPLETED
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment
Lead Sponsor:
Pronova BioPharma
Collaborating Sponsors:
Aalborg University Hospital
Conditions:
Human Immunodeficiency Virus
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 (HA...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00296153
Start Date
February 1 2006
End Date
October 1 2007
Last Update
March 11 2008
Active Locations (1)
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1
Aalborg Hospital, Department of Nephrology
Aalborg, Denmark, 9100