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CompletedNCT01041521HOSTUpdated Feb 11, 2020Results posted

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

A Phase 4 interventional study of Lovaza in High Triglyceride Level and HIV Infection, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by Tufts University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • High Triglyceride Level
  • HIV Infection

Keywords

  • HIV infection
  • Dyslipidemia
  • Elevated Triglyceride level
  • vascular function (BART)
  • arterial stiffness
  • omega three fatty acids
  • complementary therapies
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 129 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
129 participants (actual)

Study arms

  • 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

  • No intervention
    sugar pill

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

Interventions

  • DrugLovaza

    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

    Also known as: omega three fatty acids, previously known as Omacor

06

What researchers measure

Primary outcomes

  1. Triglyceride Level

    Time frame: 24 months

Secondary outcomes

  1. Vascular Function

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

    Time frame: 24 months

07

Results

Posted Feb 11, 2020
Limitations and caveats
PLEASE NOTE THAT THE PRINCIPLE INVESTIGATOR (CHRISTINE WANKE) HAS LEFT TUFTS UNIVERSITY IN RETIREMENT AND CANNOT BE CONTACTED. PLEASE ALSO NOTE THAT THIS IS NOT AN "APPLICABLE CLINICAL TRIAL". - 9/3/19

Participant flow

Participant flow — Overall Study
MilestoneLovaza (Omega Three Fatty Acid)Sugar Pill
Started6156
Completed4440
Not completed1716

Outcome measures

PrimaryTriglyceride Level
Time frame:
24 months
Reported as:
Median · mg/dL
Triglyceride Level
mg/dLLovaza (Omega Three Fatty Acid)Sugar Pill
Triglyceride Level130 (100 to 166)159 (118 to 233)
SecondaryVascular Function

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

Time frame:
24 months
Reported as:
Mean · m/s
Vascular Function
m/sLovaza (Omega Three Fatty Acid)Sugar Pill
Vascular Function833 ± 238832 ± 152

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lovaza (Omega Three Fatty Acid)—22/61 (36.1%)27/61 (44.3%)
Sugar Pill—21/56 (37.5%)16/56 (28.6%)
Most frequent serious events
Showing 10 of 46
Most frequent serious events
EventLovaza (Omega Three Fatty Acid)Sugar Pill
pneumoniaRespiratory, thoracic and mediastinal disorders5/611/56
Abdominal painGastrointestinal disorders1/613/56
heart failureCardiac disorders0/613/56
chest painCardiac disorders0/613/56
nausea/vomitingGastrointestinal disorders1/612/56
Leg swelling or edemaVascular disorders0/612/56
Pleural fluidRespiratory, thoracic and mediastinal disorders0/612/56
diabetic incidentEndocrine disorders0/612/56
renal failure/elevated creatinineRenal and urinary disorders0/612/56
joint painMusculoskeletal and connective tissue disorders0/612/56
Most frequent other events
Showing 10 of 29
Most frequent other events
EventLovaza (Omega Three Fatty Acid)Sugar Pill
excessive gas / burping /bloatingGastrointestinal disorders9/614/56
Diarrhea or loose stoolsGastrointestinal disorders8/615/56
nauseaGastrointestinal disorders6/612/56
rash or hivesSkin and subcutaneous tissue disorders5/614/56
abdominal painGastrointestinal disorders3/610/56
leg swelling and edemaVascular disorders3/612/56
vomitingGastrointestinal disorders1/612/56
painMusculoskeletal and connective tissue disorders2/610/56
elevated total bilirubinGastrointestinal disorders0/611/56
asthma/pneumoniaRespiratory, thoracic and mediastinal disorders1/611/56

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lovaza (Omega Three Fatty Acid)Sugar PillTotal
Mean53 ± 950 ± 951 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)Lovaza (Omega Three Fatty Acid)Sugar PillTotal
Female151025
Male464692
Region of Enrollment
Region of Enrollment(participants)Lovaza (Omega Three Fatty Acid)Sugar PillTotal
United States6156117
Current smoker
Current smoker(Participants)Lovaza (Omega Three Fatty Acid)Sugar PillTotal
Count of participants241640
CD4+ cell count
CD4+ cell count(cells/cubic mL)Lovaza (Omega Three Fatty Acid)Sugar PillTotal
Mean652 ± 394644 ± 309648 ± 354
Undetectable HIV viral load
Undetectable HIV viral load(Participants)Lovaza (Omega Three Fatty Acid)Sugar PillTotal
Count of participants5852110
Body mass index (BMI)
Body mass index (BMI)(kg/meters squared)Lovaza (Omega Three Fatty Acid)Sugar PillTotal
Mean28 ± 628 ± 628 ± 6
08

Study locations

1 site
  • Tufts University School of Medicine
    Boston, Massachusetts 02111, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01041521
Lead sponsor
Tufts University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Dec 31, 2009
Start date
Jan 2010
Primary completion
Aug 2014
Completion
Aug 2015
Results posted
Feb 11, 2020
Last update
Feb 11, 2020

Study contacts

Christine A Wanke, MD
principal investigator · Tufts University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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