Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: omega 3 fatty acids; placebo
Intervention description: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.; olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Seropositive HIV; Omega 3 fatty acids; Oxidative stress

Summary:

      Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in
      the prevention of complications in seropositive for HIV patients. However, they develop some
      manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing
      cardiovascular risk.

      Clinical trials in general population and in patients on hemodialysis have demonstrated a
      significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are
      believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially
      triglycerides. Also in general populations it has been described a benefit effect of omega 3
      acids on oxidative stress.

      Objective: to know the effect of omega 3 acids on different markers of oxidative stress in
      seropositive HIV patients.

      Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV
      patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They
      will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or
      placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and
      stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid
      peroxidation products) will be evaluated.

      Sample size was calculated according to different variables. We selected the biggest one
      calculated for a difference in nitric oxide of 25% after treatment between groups and a
      standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of
      31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost,
      a sample size of 35 per group was considered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Seropositive HIV patients from 20 to 55 years old

          -  On clinical score A1, A2, B1 or B2

          -  Patients who received highly active antiretroviral therapy for at least 3 months.

        Exclusion Criteria:

          -  Patients diagnosed with diabetes mellitus

          -  Patients diagnosed with hypertension

          -  Patients using hypolipidemic agents or diagnosed with dyslipidemia before receiving
             HAART therapy.

          -  Patients using protease inhibitors