Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

Phase 2

Completed

• Conditions: Heart Disease; HIV Infections
• Interventions: Drug: Placebo; Drug: Lovaza

• Registration Number: NCT01001767
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2010-03
• Study Completion: 2010-06
• Results First Submitted: 2012-03-12
• Results First Submitted QC: 2012-03-12
• Results First Posted: 2012-04-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule by mouth twice a day x 24 weeks.
Lovaza	Lovaza	Lovaza 1 gram by mouth twice a day for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Flow Mediated Dilation (FMD) of the Brachial Artery	baseline and week 24	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.

Trial Locations

Locations (1)

University Hospitals of Cleveland Case Medical Center; 🇺🇸 Cleveland, Ohio, United States