Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial|
- Change in Baseline Mean Serum Triglyceride Level at Study End [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo
- Serum HDL Level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Brachial Artery Reactivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.
Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of "% of brachial artery".
|Study Start Date:||July 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Lovaza
Lovaza, dietary counseling
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
Other Name: Omacor (omega-3-acid ethyl esters) capsules
Placebo Comparator: Placebo
Placebo, dietary counseling
2 capsules given twice daily
Other Name: corn oil
This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, with 12-week treatment periods separated by a 4-week washout. This study will be conducted at the Clinical Research Center at Tufts Medical Center.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795717
|United States, Massachusetts|
|Tufts University School of Medicine|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Christine A Wanke, MD||Tufts University School of Medicine|