Clinical trial NCT01041521: The Impact of Omega Three Fatty Acids on Vascular Function in HIV
Official title: The Impact of Omega Three Fatty Acids on Vascular Function in HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Triglyceride Level
HIV Infection
Keywords: HIV infection
Dyslipidemia
Elevated Triglyceride level
vascular function (BART)
arterial stiffness
omega three fatty acids
complementary therapies
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-12-31
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Triglyceride Level
timeFrame: 24 months
Secondary outcomes:
measure: Vascular Function
timeFrame: 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Christine A Wanke, MD
role: PRINCIPAL_INVESTIGATOR
References: