Phase 2
Completed N=35
Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
Source: ClinicalTrials.gov NCT01001767 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcomePrimary: Change in Flow Mediated Dilation (FMD) of the Brachial Artery — -0.13; 1.47 percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Flow Mediated Dilation (FMD) of the Brachial Artery |
-0.13; 1.47 | — |
Eligibility Criteria
Inclusion Criteria
- HIV+
- Ages 18-70
- HIV-1 RNA 160 and triglyceride levels >750
- Framingham risk score <6.
Data sourced from ClinicalTrials.gov (NCT01001767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.