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COMPLETEDPHASE4

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

NCT00795717•Tufts University

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.

Detailed Description

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Tufts University School of Medicine

Boston, Massachusetts, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

September 11, 2019

Enrollment

ACTUAL participants

Conditions

Cardiovascular DiseaseHIV Infection

Interventions

Lovaza

DRUG

Placebo

DRUG

Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

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