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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christine A. Wanke, Tufts University
ClinicalTrials.gov Identifier:
NCT01041521
First received: December 30, 2009
Last updated: April 9, 2014
Last verified: April 2014

December 30, 2009
April 9, 2014
January 2010
January 2015   (final data collection date for primary outcome measure)
triglyceride level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01041521 on ClinicalTrials.gov Archive Site
vascular function [ Time Frame: 6 months and 24 months ] [ Designated as safety issue: No ]
vascular function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Impact of Omega Three Fatty Acids on Vascular Function in HIV
The Impact of Omega Three Fatty Acids on Vascular Function in HIV

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • High Triglyceride Level
  • HIV Infection
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
  • 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

    Intervention: Drug: Lovaza
  • No Intervention: sugar pill

    Dietary Supplement: sugar pill

    2 capsules given twice daily Arms: sugar pill

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01041521
LVZ112667, 1R01HL096585-01A1
Yes
Christine A. Wanke, Tufts University
Christine A. Wanke
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Christine A Wanke, MD Tufts University
Tufts University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP