Expired Study
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Boston, Massachusetts 02111


Purpose:

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.


Study summary:

This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, with 12-week treatment periods separated by a 4-week washout. This study will be conducted at the Clinical Research Center at Tufts Medical Center.


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 < 1,500 mg/dl - Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changes during the course of the study - Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on the study unless deemed medically necessary by the participant's medical provider and approved by Dr. Wanke - Female participants of reproductive age must not be pregnant (negative test) or lactating at screening and throughout the trial and agree to use 2 methods of barrier contraception for the course of the trial and 2 months after the trial unless they are surgically sterilized (tubal ligation or hysterectomy), or post-menopausal with no menses for > 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


NCT ID:

NCT00795717


Primary Contact:

Principal Investigator
Christine A Wanke, MD
Tufts University School of Medicine


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02111
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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