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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
Sponsor:
Collaborators:
The Campbell Foundation
Case Western Reserve University
GlaxoSmithKline
Information provided by (Responsible Party):
Grace McComsey, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 27, 2009
Results First Submitted Date  ICMJE March 12, 2012
Results First Posted Date  ICMJE April 9, 2012
Last Update Posted Date January 7, 2015
Study Start Date  ICMJE April 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2009)
To ascertain by means of flow-mediated dilation of the brachial artery, whether omega-3 fatty acids affect endothelial function. [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2009)
To assess the safety and tolerability of 24 weeks of omega-3 fatty acids in HIV-infected subjects [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
Official Title  ICMJE Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE
  • HIV Infections
  • Heart Disease
Intervention  ICMJE
  • Drug: Lovaza
    Lovaza one gram twice a day for 24 weeks
    Other Name: Omega-3 fatty acid
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2009)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001767
Other Study ID Numbers  ICMJE AIDS 10-08-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grace McComsey, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE
  • The Campbell Foundation
  • Case Western Reserve University
  • GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Grace McComsey, MD University Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date December 2014

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