Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
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.
|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|
- 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.
|Study Start Date:||April 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Lovaza
Lovaza 1 gram by mouth twice a day for 24 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001767
|United States, Ohio|
|University Hospitals of Cleveland Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Grace McComsey, MD||University Hospitals of Cleveland Case Medical Center|