Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Genital Diseases Heart Disease Heart Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lovaza

Drug

Lovaza one gram twice a day for 24 weeks

Other names: Omega-3 fatty acid

Placebo

Drug

Placebo

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

Case Western Reserve University
GlaxoSmithKline
The Campbell Foundation

Registry information

Official study title

Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Oct 27, 2009
Registry last updated: Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed