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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Christine A. Wanke

Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party)
Christine A. Wanke, Tufts University

ClinicalTrials.gov Identifier
NCT01041521

First received: December 30, 2009
Last updated: December 14, 2016
Last Verified: December 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
High Triglyceride Level
HIV Infection

Drug : Lovaza
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Omega Three Fatty Acids on Vascular Function in HIV

Further study details as provided by Christine A. Wanke, Tufts University:

Primary Outcome Measures

  • triglyceride level [ Time Frame: 24 months ]
Secondary Outcome Measures:
  • vascular function [ Time Frame: 6 months and 24 months ]

Enrollment: 129
Study Start Date: January 2010
Study Completion Date: August 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Lovaza (omega three fatty acid)
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
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 24 months

Other Name:
  • omega three fatty acids
  • previously known as Omacor

No Intervention: sugar pill
Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill

Detailed Description:

While omega-three fatty acids have been shown to be beneficial for 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 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:

  1. 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).
  2. 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 CRP, sPLA2 and by levels of arachidonic acid.
  3. 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041521

Locations

United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Christine A. Wanke
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Christine A Wanke, MD Tufts University
More Information

More Information


Responsible Party: Christine A. Wanke, Public Health & Community Medicine, Tufts University  
ClinicalTrials.gov Identifier: NCT01041521   History of Changes  
Other Study ID Numbers: LVZ112667  
  1R01HL096585-01A1  
Study First Received: December 30, 2009  
Last Updated: December 14, 2016  

Keywords provided by Christine A. Wanke, Tufts University:

HIV infection
Dyslipidemia
Elevated Triglyceride level
vascular function (BART)
arterial stiffness
omega three fatty acids
complementary therapies

Additional relevant MeSH terms:
HIV Infections
Hypertriglyceridemia

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.