Phase 4 Completed N=41 Randomized Double-blind Treatment

Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

Cardiovascular Disease · HIV

Source: ClinicalTrials.gov NCT00795717 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcomePrimary: Change in Baseline Mean Serum Triglyceride Level at Study End — -103.0; -23.4 mg/dl

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.