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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795717
First Posted: November 21, 2008
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Todd Conley, Tufts University
  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.

Condition Intervention Phase
Cardiovascular Disease HIV Infection Drug: Lovaza Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

Resource links provided by NLM:


Further study details as provided by Todd Conley, Tufts University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Serum HDL Level [ Time Frame: 12 weeks ]
  • 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".



Enrollment: 41
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lovaza
Lovaza, dietary counseling
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
Placebo Comparator: Placebo
Placebo, dietary counseling
Drug: Placebo
2 capsules given twice daily
Other Name: corn oil

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795717


Locations
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Todd Conley
Investigators
Principal Investigator: Christine A Wanke, MD Tufts University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Todd Conley, Associate Director, Office of Research Administration, Tufts University
ClinicalTrials.gov Identifier: NCT00795717     History of Changes
Other Study ID Numbers: LVZ111888
011293-GSK Contract Reference#
First Submitted: November 19, 2008
First Posted: November 21, 2008
Results First Submitted: May 7, 2013
Results First Posted: December 8, 2014
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by Todd Conley, Tufts University:
HIV
cardiovascular risk
atherogenic lipid profile
brachial artery reactivity
omega three fatty acids

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases


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