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Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

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ClinicalTrials.gov Identifier: NCT00296153
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : March 11, 2008
Aalborg Universitetshospital
Information provided by:
Pronova BioPharma

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)

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2006
Primary Completion Date : November 2006
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. The change from week 0 (baseline) to week 12 for: Pulse Wave Velocity, Flow medicated vasodilation [ Time Frame: baseline and 12 weeks ]
  2. HDL-cholesterol, LDL-cholesterol, total cholesterol [ Time Frame: baseline and 12 weeks ]
  3. Inflammatory parameters: ICAM, VCAM, sensitive CRP [ Time Frame: baseline and 12 weeks ]
  4. 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 ]
  5. Safety parameters [ Time Frame: baseline and 12 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296153

Aalborg Hospital, Department of Nephrology
Aalborg, Denmark, 9100
Sponsors and Collaborators
Pronova BioPharma
Aalborg Universitetshospital
Principal Investigator: Jeppe H. Christensen, PhD Aalborg Hospital, Department of Nephrology

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
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: March 11, 2008
Last Verified: March 2008

Keywords provided by Pronova BioPharma:
Human immunodeficiency Virus (HIV)
Highly Active Antiviral Therapy (HAART)
Ischemic Heart Disease
Endothelial function
Treatment Experienced

Additional relevant MeSH terms:
Heart Diseases
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases