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Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT01001767
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : April 9, 2012
Last Update Posted : January 7, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Heart Disease Drug: Lovaza Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk
Study Start Date : April 2009
Primary Completion Date : March 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Change in Flow Mediated Dilation (FMD) of the Brachial Artery [ Time Frame: baseline and week 24 ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01001767

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

Responsible Party: Grace McComsey, Principal Investigator, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01001767     History of Changes
Other Study ID Numbers: AIDS 10-08-24
First Posted: October 27, 2009    Key Record Dates
Results First Posted: April 9, 2012
Last Update Posted: January 7, 2015
Last Verified: December 2014

Keywords provided by Grace McComsey, University Hospital Case Medical Center:
Omega-3 Fatty Acids
Heart Disease
Treatment experienced

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