Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Case Western Reserve University; GlaxoSmithKline; The Campbell Foundation

Criteria

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.