Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections, Heart Disease

In brief

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.

Key facts

Study ID

NCT01001767

Run by

University Hospitals Cleveland Medical Center

People needed

35

Starts

2009-04-01

Expected to finish

2010-06-01

Last updated by the study team

2015-01-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Active infection
• Inflammation or malignancy
• Uncontrolled diabetes or hypothyroidism
• LDL (low density lipoprotein) cholesterol >160 and triglyceride levels >750
• Framingham risk score <6.

Where it is running

• University Hospitals of Cleveland Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.