The Impact of Omega Three Fatty Acids on Vascular Function in HIV - Full Text View

Sponsor:	Todd Conley
Collaborator:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):	Todd Conley, Tufts University
ClinicalTrials.gov Identifier:	NCT01041521

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Impact of Omega Three Fatty Acids on Vascular Function in HIV

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Triglycerides

Drug Information available for: Omega-3-acid Ethyl Esters Lovaza

U.S. FDA Resources

Further study details as provided by Tufts University:

Primary Outcome Measures:

triglyceride level [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

vascular function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2010
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (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 Names: omega three fatty acids previously known as Lovaza
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 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 CRP, sPLA2 and by levels of arachidonic acid.
To demonstrate the impact of omega-three fatty acid intake on BART at 24 weeks and on arterial stiffness at 24 months.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

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

Contacts

Contact: Jul Gerrior, RD

617-636-3636

jul.gerrior@tufts.edu

Locations

United States, Massachusetts
Tufts University School of Medicine	Recruiting
Boston, Massachusetts, United States, 02111
Contact: Jul Gerrior, RD 617-636-3636 jul.gerrior@tufts.edu
Principal Investigator: Christine A Wanke, MD

Sponsors and Collaborators

Todd Conley

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Christine A Wanke, MD

Tufts University

More Information

No publications provided

Responsible Party:	Todd Conley, Associate Director, Office of Research Administration, Tufts University
ClinicalTrials.gov Identifier:	NCT01041521 History of Changes
Other Study ID Numbers:	LVZ112667, 1R01HL096585-01A1
Study First Received:	December 30, 2009
Last Updated:	November 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by 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
Acquired Immunodeficiency Syndrome
Hypertriglyceridemia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 24, 2012