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

October 22, 2009
May 14, 2012
April 2009
March 2010   (final data collection date for primary outcome measure)
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.
To ascertain by means of flow-mediated dilation of the brachial artery, whether omega-3 fatty acids affect endothelial function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01001767 on ClinicalTrials.gov Archive Site
Not Provided
To assess the safety and tolerability of 24 weeks of omega-3 fatty acids in HIV-infected subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
  • HIV Infections
  • Heart Disease
  • Drug: Lovaza
    Lovaza one gram twice a day for 24 weeks
    Other Name: Omega-3 fatty acid
  • Drug: Placebo
    Placebo
  • Active Comparator: Lovaza
    Lovaza 1 gram by mouth twice a day for 24 weeks.
    Intervention: Drug: Lovaza
  • Placebo Comparator: Placebo
    Placebo capsule by mouth twice a day x 24 weeks.
    Intervention: Drug: Placebo
Hileman CO, Carman TL, Storer NJ, Labbato DE, White CA, McComsey GA. Omega-3 fatty acids do not improve endothelial function in virologically suppressed HIV-infected men: a randomized placebo-controlled trial. AIDS Res Hum Retroviruses. 2012 Jul;28(7):649-55. doi: 10.1089/AID.2011.0088. Epub 2011 Oct 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01001767
AIDS 10-08-24
No
Grace McComsey, University Hospitals of Cleveland
University Hospitals of Cleveland
  • The Campbell Foundation
  • Case Western Reserve University
  • GlaxoSmithKline
Principal Investigator: Grace McComsey, MD University Hospitals of Cleveland Case Medical Center
University Hospitals of Cleveland
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP