Phase 4
N=41
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Cardiovascular Disease · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00795717 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Change in Baseline Mean Serum Triglyceride Level at Study End — -103.0; -23.4 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lovaza (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline Mean Serum Triglyceride Level at Study End |
-103.0; -23.4 | — |
| SECONDARY Serum HDL Level |
39; 36 | — |
| SECONDARY Brachial Artery Reactivity |
6.4; 7.5 | — |
Summary
The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.
Eligibility Criteria
Inclusion Criteria
- HIV-infected men and women at least 18 years of age
- On stable HAART for previous three months and without anticipated changes in their HAART regimen throughout the duration of the study
- Fasting triglycerides > 150 mg/dl and 1 year
- Ability to provide consent
Exclusion Criteria
- Plasma HIV-1 RNA > 10,000
- Previous history of atherosclerotic disease or diabetes mellitus
- Change in HAART regimen over three months prior to study entry
- Change in lipid lowering therapy within 2 months
- On chronic anticoagulants such as heparin or coumadin
- On fish oil, omega 3 supplements, or Omacor currently or during the past month
Data sourced from ClinicalTrials.gov (NCT00795717). 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.