The Impact of Omega Three Fatty Acids on Vascular Function in HIV
Condition: High Triglyceride Level; HIV Infection
MeSH terms: HIV Infections; Hypertriglyceridemia
Intervention: Lovaza
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV infection; Dyslipidemia; Elevated Triglyceride level; vascular function (BART); arterial stiffness; omega three fatty acids; complementary therapies

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.
    

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