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

Sponsors and Collaborators:	Pronova Biocare Aalborg Hospital
Information provided by:	Pronova Biocare
ClinicalTrials.gov Identifier:	NCT00296153

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 IV

MedlinePlus related topics: AIDS Heart Diseases

Drug Information available for: Omacor Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pronova Biocare:

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
1: Active Comparator Omacor 1000mg x 4 / day	Drug: Omega-3-acid ethyl esters 90 Omacor capsule 1000mg x 4 per day. Duration 12 weeks
2: Placebo Comparator	Drug: Omega-3-acid ethyl esters 90 Omacor capsule 1000mg x 4 per day. Duration 12 weeks

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 Biocare

Aalborg Hospital

Investigators

Principal Investigator:

Jeppe H. Christensen, PhD

Aalborg Hospital, Department of Nephrology

More Information

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

Keywords provided by Pronova Biocare:

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

Triglycerides
Endothelial function
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Heart Diseases
HIV Infections
Myocardial Ischemia
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Vascular Diseases
Ischemia
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009