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The Impact of Omega Three Fatty Acids on Vascular Function in HIV (HOST)

Primary Purpose

High Triglyceride Level, HIV Infection

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

About this trial

This is an interventional treatment trial for High Triglyceride Level focused on measuring HIV infection, Dyslipidemia, Elevated Triglyceride level, vascular function (BART), arterial stiffness, omega three fatty acids, complementary therapies

Eligibility Criteria

18 Years - undefined (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 the previous two months and without anticipated changes in their HAART regimen throughout the duration of the study,
  • Fasting triglycerides > 150 mg/dl and < 2,500 mg/dl
  • Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changed during the course of the study.
  • Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), and Estrogens (e.g., Estinyl; Estrace; Estraderm), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on 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 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 copies/ml
  • change in HAART regimen over two months prior to study entry
  • change in lipid lowering therapy within 2 months (8 weeks)
  • Pregnancy in female participants
  • Evidence of liver or renal disease with values of liver enzymes > 5 X upper limit of normal or creatinine > 1.5 X upper limit of normal
  • presence of active opportunistic infection or malignancy
  • presence of other inflammatory or end organ disease (, rheumatoid arthritis, active treatment for hepatitis c, or other diseases that may alter inflammatory markers)
  • routine ingestion of fish oil (individuals who have used fish oil would be reconsidered for study participation if they discontinue use of fish oil for 8 weeks and TG levels remain elevated).
  • Allergic to fish or Lovaza
  • BMI >35

Sites / Locations

  • Tufts University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lovaza (omega three fatty acid)

sugar pill

Arm 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. Other Names: Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules

Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill

Outcomes

Primary Outcome Measures

Triglyceride Level

Secondary Outcome Measures

Vascular Function
Carotid-femoral pulse wave velocity is a measure of arterial stiffness, with lower values indicating less arterial stiffness.

Full Information

First Posted
December 30, 2009
Last Updated
February 10, 2020
Sponsor
Tufts University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01041521
Brief Title
The Impact of Omega Three Fatty Acids on Vascular Function in HIV
Acronym
HOST
Official Title
The Impact of Omega Three Fatty Acids on Vascular Function in HIV
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study seeks to determine if the use of omega three fatty acids in individuals infected with HIV and with high triglycerides leads to improved triglyceride levels, better blood vessel function and decrease in the amount of obstruction in blood vessels.
Detailed Description
While omega-three fatty acids have been shown to be beneficial for triglycerides (TG) and HDL-C levels in HIV uninfected individuals and in some small, short duration studies in HIV-infected individuals, there are no data that extend these observations to determine whether intake of omega-three fats over a more prolonged time period will also have a beneficial impact on functional outcomes such as vascular endothelial function and anatomic surrogate markers of cardiovascular disease (CVD) in HIV-infected patients. We propose a randomized, double blind trial of purified omega-three fatty acids in HIV-infected individuals with elevated levels of triglycerides. While the impact of omega-three fatty acids on lipid profiles should be evident early (within 12 weeks); we propose to conduct this trial for a full 24 months to test our overall hypothesis that this intervention will not only improve triglyceride and HDL-C levels, improve HDL-subpopulations, plasma and membrane phospholipids and decrease inflammation, but will also improve brachial artery reactivity testing (BART) as a measure of vascular endothelial function at 24 weeks and 24 months and arterial stiffness measured by a pulse wave velocity test as a surrogate marker of CVD risk at 24 months when compared to controls. The specific aims of this proposal include: To conduct a randomized, placebo controlled trial of omega-three fatty acids over 24 months in HIV-infected individuals with elevated levels of triglycerides (> 150 mg/dl). To demonstrate the impact of omega-three fatty acid intake on TG levels and on HDL-C levels, HDL subpopulations, composition of plasma and membrane phospholipids, and chronic inflammation as measured by c-reactive protein (CRP), sPLA2 and by levels of arachidonic acid. To demonstrate the impact of omega-three fatty acid intake on BART at 24 weeks and 24 months and on arterial stiffness at 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Triglyceride Level, HIV Infection
Keywords
HIV infection, Dyslipidemia, Elevated Triglyceride level, vascular function (BART), arterial stiffness, omega three fatty acids, complementary therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lovaza (omega three fatty acid)
Arm Type
Experimental
Arm 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. Other Names: Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules
Arm Title
sugar pill
Arm Type
No Intervention
Arm Description
Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill
Intervention Type
Drug
Intervention Name(s)
Lovaza
Other Intervention Name(s)
omega three fatty acids, previously known as Omacor
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 24 months
Primary Outcome Measure Information:
Title
Triglyceride Level
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Vascular Function
Description
Carotid-femoral pulse wave velocity is a measure of arterial stiffness, with lower values indicating less arterial stiffness.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected men and women at least 18 years of age, On stable HAART for the previous two months and without anticipated changes in their HAART regimen throughout the duration of the study, Fasting triglycerides > 150 mg/dl and < 2,500 mg/dl Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy must be stable for 8 weeks and cannot be changed during the course of the study. Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol), and Estrogens (e.g., Estinyl; Estrace; Estraderm), however therapy with these agents must be stable for 8 weeks before starting the study and cannot be altered while on 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 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 copies/ml change in HAART regimen over two months prior to study entry change in lipid lowering therapy within 2 months (8 weeks) Pregnancy in female participants Evidence of liver or renal disease with values of liver enzymes > 5 X upper limit of normal or creatinine > 1.5 X upper limit of normal presence of active opportunistic infection or malignancy presence of other inflammatory or end organ disease (, rheumatoid arthritis, active treatment for hepatitis c, or other diseases that may alter inflammatory markers) routine ingestion of fish oil (individuals who have used fish oil would be reconsidered for study participation if they discontinue use of fish oil for 8 weeks and TG levels remain elevated). Allergic to fish or Lovaza BMI >35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine A Wanke, MD
Organizational Affiliation
Tufts University
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

Learn more about this trial

The Impact of Omega Three Fatty Acids on Vascular Function in HIV

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