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

This study has been completed.
Information provided by (Responsible Party):
Todd Conley, Tufts University Identifier:
First received: November 19, 2008
Last updated: December 2, 2014
Last verified: December 2014

November 19, 2008
December 2, 2014
July 2008
October 2010   (final data collection date for primary outcome measure)
Change in Baseline Mean Serum Triglyceride Level at Study End [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo
Serum Triglyceride Level [ Time Frame: 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00795717 on Archive Site
  • Serum HDL level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Brachial Artery Reactivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.

    Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of "% of brachial artery".

  • Serum HDL level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Brachial Artery Reactivity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

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.

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.

Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cardiovascular Disease
  • HIV Infection
  • Drug: Lovaza
    Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
    Other Name: Omacor (omega-3-acid ethyl esters) capsules
  • Drug: Placebo
    2 capsules given twice daily
    Other Name: corn oil
  • Active Comparator: Lovaza
    Lovaza, dietary counseling
    Intervention: Drug: Lovaza
  • Placebo Comparator: Placebo
    Placebo, dietary counseling
    Intervention: Drug: Placebo
Paranandi A, Asztalos BF, Mangili A, Kuvin J, Gerrior J, Sheehan H, Skinner SC, Tang AM, Wanke CA. Short communication: effects of omega-3 fatty acids on triglycerides and high-density lipoprotein subprofiles in HIV-infected persons with hypertriglyceridemia. AIDS Res Hum Retroviruses. 2014 Aug;30(8):800-5. doi: 10.1089/AID.2014.0005.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2010
October 2010   (final data collection date for primary outcome measure)

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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
LVZ111888, 011293-GSK Contract Reference#
Todd Conley, Tufts University
Todd Conley
Not Provided
Principal Investigator: Christine A Wanke, MD Tufts University School of Medicine
Tufts University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP