Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

Ischemic Heart Disease Clinical Trial

Official title:

Omacor; Omega-3-Acid Ethyl Ester 90 (n-3 PUFA) and Risk Factors in HIV Infected Patients Treated With HAART, With Special Focus on Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296153
• Other study ID #: CTN K85 05026
• Secondary ID: Eudract no: 2005
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2006
• Last updated: March 10, 2008
• Start date: February 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2008
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Coronary Artery Disease
• Heart Diseases
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Omega-3-acid ethyl esters 90
Omacor capsule 1000mg x 4 per day. Duration 12 weeks

Locations

Country	Name	City	State
Denmark	Aalborg Hospital, Department of Nephrology	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Pronova BioPharma	Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from week 0 (baseline) to week 12 for: Plasma triglycerides		baseline and 12 weeks
Secondary	The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation		baseline and 12 weeks
Secondary	HDL-cholesterol, LDL-cholesterol, total cholesterol		baseline and 12 weeks
Secondary	Inflammatory parameters: ICAM, VCAM, sensitive CRP		baseline and 12 weeks
Secondary	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
Secondary	Safety parameters		baseline and 12 weeks	Yes