Status:
COMPLETED
Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
The Campbell Foundation
Case Western Reserve University
Conditions:
HIV Infections
Heart Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 en...
Eligibility Criteria
Inclusion
- 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
- Active infection
- Inflammation or malignancy
- Uncontrolled diabetes or hypothyroidism
- LDL (low density lipoprotein) cholesterol \>160 and triglyceride levels \>750
- Framingham risk score \<6.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01001767
Start Date
April 1 2009
End Date
June 1 2010
Last Update
January 7 2015
Active Locations (1)
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1
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106