Conditions: Cardiovascular Disease HIV Infection
Keywords: HIV cardiovascular risk atherogenic lipid profile brachial artery reactivity omega three fatty acids
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 41
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Lovaza, dietary counseling arm 2: Placebo, dietary counseling

Interventions: intervention 1: Lovaza intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 2 capsules given twice daily

Protocol document: