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Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborators:
The Campbell Foundation
Case Western Reserve University
GlaxoSmithKline
Information provided by (Responsible Party):
Grace McComsey, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01001767
First received: October 22, 2009
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.


Condition Intervention Phase
HIV Infections
Heart Disease
 Drug: Lovaza
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Change in Flow Mediated Dilation (FMD) of the Brachial Artery [ Time Frame: baseline and week 24 ] [ Designated as safety issue: No ]
    Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.


Enrollment: 35
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lovaza
Lovaza 1 gram by mouth twice a day for 24 weeks.
 Drug: Lovaza
Lovaza one gram twice a day for 24 weeks
Other Name: Omega-3 fatty acid
Placebo Comparator: Placebo
Placebo capsule by mouth twice a day x 24 weeks.
 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV+
  • Ages 18-70
  • HIV-1 RNA <400 copies/ml.
  • On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos.

Exclusion Criteria:

  • Active infection
  • Inflammation or malignancy
  • Uncontrolled diabetes or hypothyroidism
  • LDL (low density lipoprotein) cholesterol >160 and triglyceride levels >750
  • Framingham risk score <6.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001767

Locations
United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
The Campbell Foundation
Case Western Reserve University
GlaxoSmithKline
Investigators
Principal Investigator: Grace McComsey, MD University Hospitals of Cleveland Case Medical Center
  More Information

Publications:

Responsible Party: Grace McComsey, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01001767     History of Changes
Other Study ID Numbers: AIDS 10-08-24
Study First Received: October 22, 2009
Results First Received: March 12, 2012
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
Omega-3 Fatty Acids
HIV
Heart Disease
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Heart Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013