Omega-3 Fatty Acids for High Triglycerides in HIV-infected Patients
Condition: HIV Infections; AIDS; Dyslipidemia; Hypertriglyceridemia
MeSH terms: Dyslipidemias; Hypertriglyceridemia
Intervention: Omega-3 fatty acid administration; Placebo
Intervention description: LOVAZA 1 gram capsules, 4 capsules daily; Corn-oil placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIDS; HIV; HAART; Lipids; Triglycerides; Cholesterol; omega-3 fatty acids; bone turnover; inflammation; insulin resistance

Summary:

      The purpose of this study is to evaluate the efficacy and safety of omega-3-fatty acids in
      HIV-infected patients with hypertriglyceridemia. In addition, we, the researchers, will
      evaluate the effect of omega-3 fatty acid administration of markers of bone turnover and
      inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and willingness to give informed consent

          -  Age ≥ 18 years

          -  HIV-1 infection documented at any time prior to study entry

          -  Fasting plasma triglyceride value between 200 and 1000 mg/dL on two occasions within 4
             weeks

          -  Subjects must be receiving a stable antiretroviral medication regimen for > 3 months
             without any anticipated changes during the study interval

          -  Females must not be pregnant or lactating. Females of childbearing potential and males
             must use a reliable means of contraception

          -  On stable lipid modification pharmacotherapy for at least 8 weeks prior to study entry

        Exclusion Criteria

          -  Hemoglobin A1C > 8.5 %

          -  Uncontrolled hypothyroidism (TSH > 4.5)

          -  HIV viral load > 5,000 copies/ml (cpm),

          -  Active liver disease and/or liver transaminases greater than 2.0 X upper limit of
             normal

          -  Active kidney disease or serum creatinine > 2.5 mg/dL

          -  Myocardial infarction, unstable ischemic heart disease, stroke, or coronary
             revascularization procedure

          -  Uncontrolled hypertension within 4 weeks of study entry (SBP > 180 mmHg or DBP > 100
             mmHg)

          -  Use of systemic cancer chemotherapy within 8 weeks of study entry

          -  Pregnancy or breastfeeding

          -  Drug or alcohol dependence, or other conditions which may affect study compliance

          -  History of coagulopathy or use of anticoagulants such as warfarin

          -  Use of omega-3 fatty acid preparation in the 12 weeks prior to randomization

          -  Significant changes in clinical status from the Screening Visit which would preclude
             the patient from being an appropriate candidate.

          -  Any of the following laboratory parameters: hematocrit < 25%, absolute neutrophil
             count < 1.5 x 10^9/L, platelets < 100 x 10^9/L or hemoglobin < 8.0 gm/dL