Clinical trial NCT00296153: Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Immunodeficiency Virus
Ischemic Heart Disease
Keywords: Human immunodeficiency Virus (HIV)
Highly Active Antiviral Therapy (HAART)
Ischemic Heart Disease
OMACOR
Triglycerides
Endothelial function
Treatment Experienced
Lead sponsor: Pronova BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Aalborg University Hospital
First posted: 2006-02-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change from week 0 (baseline) to week 12 for: Plasma triglycerides
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation
timeFrame: baseline and 12 weeks
measure: HDL-cholesterol, LDL-cholesterol, total cholesterol
timeFrame: baseline and 12 weeks
measure: Inflammatory parameters: ICAM, VCAM, sensitive CRP
timeFrame: baseline and 12 weeks
measure: Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Factor, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes
timeFrame: baseline and 12 weeks
measure: Safety parameters
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital, Department of Nephrology
Study officials:
affiliation: Aalborg Hospital, Department of Nephrology
name: Jeppe H. Christensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: