Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment - Full Text View

Purpose

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)

Condition	Intervention	Phase
Human Immunodeficiency Virus Ischemic Heart Disease	Drug: Omega-3-acid ethyl esters 90	Phase 4

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Coronary Artery Disease HIV/AIDS Heart Diseases

Drug Information available for: Omega-3-acid Ethyl Esters Lovaza Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Pronova BioPharma:

Primary Outcome Measures:

The change from week 0 (baseline) to week 12 for: Plasma triglycerides [ Time Frame: baseline and 12 weeks ]

Secondary Outcome Measures:

The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation [ Time Frame: baseline and 12 weeks ]
HDL-cholesterol, LDL-cholesterol, total cholesterol [ Time Frame: baseline and 12 weeks ]
Inflammatory parameters: ICAM, VCAM, sensitive CRP [ Time Frame: baseline and 12 weeks ]
Apo A, Apo B, Lp(a), fibrinogen, PAI-1 ag, vw-Factor, thrombomodulin, oxidized LDL, small dense LDL, LTB4 from stimulated granulocytes [ Time Frame: baseline and 12 weeks ]
Safety parameters [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	51
Study Start Date:	February 2006
Study Completion Date:	October 2007
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Omacor 1000mg x 4 / day	Drug: Omega-3-acid ethyl esters 90 Omacor capsule 1000mg x 4 per day. Duration 12 weeks Other Name: Omacor versus placebo
Placebo Comparator: 2	Drug: Omega-3-acid ethyl esters 90 Omacor capsule 1000mg x 4 per day. Duration 12 weeks Other Name: Omacor versus placebo

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:

the immunodeficient effects of the HIV infection itself may influence the progression of arteriosclerosis
the higher levels of risk behaviour in this group of patients (i.e. high prevalence of smokers in this group)
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296153

Locations

Denmark
Aalborg Hospital, Department of Nephrology
Aalborg, Denmark, 9100

Sponsors and Collaborators

Pronova BioPharma

Aalborg Universityhospital

Investigators

Principal Investigator:

Jeppe H. Christensen, PhD

Aalborg Hospital, Department of Nephrology

More Information

No publications provided

Responsible Party:	Runar Vige, Pronova BioPharma
ClinicalTrials.gov Identifier:	NCT00296153 History of Changes
Other Study ID Numbers:	CTN K85 05026, Eudract no: 2005-005135-10
Study First Received:	February 23, 2006
Last Updated:	March 10, 2008
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Pronova BioPharma:

Human immunodeficiency Virus (HIV)
Highly Active Antiviral Therapy (HAART)
Ischemic Heart Disease
OMACOR

Triglycerides
Endothelial function
Treatment Experienced

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Immunologic Deficiency Syndromes
Ischemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013