Skip to main content
OpenTrials
Completed

NCT Number: NCT00296153

Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Genital Diseases HIV Infections Heart Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Ischemic Heart Disease Lentivirus Infections Myocardial Ischemia RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg Hospital, Department of Nephrology

Aalborg, 9100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3-acid ethyl esters 90

Drug

Omacor capsule 1000mg x 4 per day. Duration 12 weeks

Other names: Omacor versus placebo

Primary outcomes

  1. The change from week 0 (baseline) to week 12 for: Plasma triglycerides

    Time frame: baseline and 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pronova BioPharma

Industry

Collaborators

  • Aalborg University Hospital

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Feb 24, 2006
Registry last updated
Mar 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.