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Completed

NCT Number: NCT00795717

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.

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Key information

Conditions

Cardiovascular Disease Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lovaza

Drug

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 names: Omacor (omega-3-acid ethyl esters) capsules

Placebo

Drug

2 capsules given twice daily

Other names: corn oil

Primary outcomes

  1. Change in Baseline Mean Serum Triglyceride Level at Study End

    Time frame: Baseline and 12 weeks

    Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo

Secondary outcomes

  1. Serum HDL Level

    Time frame: 12 weeks

  2. Brachial Artery Reactivity

    Time frame: 12 weeks

    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".

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Acronym: HALO

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2008
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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