Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

University Hospitals Cleveland Medical Center35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

HIV Infections Heart Disease

Interventions

LovazaDRUG

Lovaza one gram twice a day for 24 weeks

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Change in Flow Mediated Dilation (FMD) of the Brachial Artery

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.

Time frame: baseline and week 24

Data from ClinicalTrials.gov

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