Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001767
• Other study ID #: AIDS 10-08-24
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2009
• Last updated: December 18, 2014
• Start date: April 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases
• HIV Infections

Intervention

Drug:
• Lovaza
Lovaza one gram twice a day for 24 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland Case Medical Center	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Case Western Reserve University, GlaxoSmithKline, The Campbell Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hileman CO, Carman TL, Storer NJ, Labbato DE, White CA, McComsey GA. Omega-3 fatty acids do not improve endothelial function in virologically suppressed HIV-infected men: a randomized placebo-controlled trial. AIDS Res Hum Retroviruses. 2012 Jul;28(7):649 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and week 24	No