Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

This study has been completed.
Sponsor:
Collaborator:
Aalborg Universitetshospital
Information provided by:
Pronova BioPharma
ClinicalTrials.gov Identifier:
NCT00296153
First received: February 23, 2006
Last updated: March 10, 2008
Last verified: March 2008
  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:


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:

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Universitetshospital
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
Coronary Artery Disease
Heart Diseases
HIV Infections
Immunologic Deficiency Syndromes
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Vascular Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014