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

Primary Purpose

Cardiovascular Disease, HIV Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lovaza
Placebo
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring HIV, cardiovascular risk, atherogenic lipid profile, brachial artery reactivity, omega three fatty acids

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tufts University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lovaza

Placebo

Arm Description

Lovaza, dietary counseling

Placebo, dietary counseling

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum HDL Level
Brachial Artery Reactivity
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".

Full Information

First Posted
November 19, 2008
Last Updated
August 30, 2019
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT00795717
Brief Title
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Acronym
HALO
Official Title
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, HIV Infection
Keywords
HIV, cardiovascular risk, atherogenic lipid profile, brachial artery reactivity, omega three fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lovaza
Arm Type
Active Comparator
Arm Description
Lovaza, dietary counseling
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, dietary counseling
Intervention Type
Drug
Intervention Name(s)
Lovaza
Other Intervention Name(s)
Omacor (omega-3-acid ethyl esters) capsules
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
corn oil
Intervention Description
2 capsules given twice daily
Primary Outcome Measure Information:
Title
Change in Baseline Mean Serum Triglyceride Level at Study End
Description
Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Serum HDL Level
Time Frame
12 weeks
Title
Brachial Artery Reactivity
Description
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".
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine A Wanke, MD
Organizational Affiliation
Tufts University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24988179
Citation
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.
Results Reference
derived

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

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