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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; High Triglyceride Level
• Intervention / Treatment: Drug: Lovaza

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:

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 c-reactive protein (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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: omega three fatty acids; previously known as Omacor
NO_INTERVENTION: sugar pill; Dietary Supplement: sugar pill 2 capsules given twice daily Arms: sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Triglyceride Level	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular Function	Carotid-femoral pulse wave velocity is a measure of arterial stiffness, with lower values indicating less arterial stiffness.	24 months

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Christine A Wanke, MD, Tufts University

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: December 30, 2009
• First Submitted That Met QC Criteria: December 30, 2009
• First Posted (ESTIMATE): December 31, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Dyslipidemia; complementary therapies; HIV infection; arterial stiffness; omega three fatty acids; Elevated Triglyceride level; vascular function (BART)
• Additional Relevant MeSH Terms: Metabolic Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; HIV Infections; Hypertriglyceridemia
• Other Study ID Numbers: LVZ112667; 1R01HL096585-01A1 (NIH)