Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
Condition: HIV; Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: pitavastatin; placebo
Intervention description: Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
Intervention MeSH terms: Pitavastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir

Summary:

      Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in
      HIV-infected patients who are on antiretroviral therapy especially protease inhibitors
      including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug
      interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected
      individuals. The study was conducted as a randomized, double-blind, crossover study comparing
      the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with
      dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either
      placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given
      the other treatment for an additional 12 weeks. Patients were observed for lipid profiles
      including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high
      density lipoprotein (HDL); and the side effects including clinical and laboratory (serum
      aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase
      (CPK)). The follow-up visits were every 4 weeks until the end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged ≥18 years

          -  able to provide informed consent

          -  had confirmed HIV infection

          -  on ART including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that
             were not changed within 12 weeks before the randomization

          -  patients who had cholesterol level between 200 and 500 and LDL between 130 and 400
             mg/dL without any lipid-lowering agent or discontinued the lipid-lowering agent at
             least 1 month prior to randomization

        Exclusion Criteria:

          -  had the history of pitavastatin and/or the constituent of the drugs allergy

          -  known history of myocardial infarction and/or ischemic stroke within 1 month prior to
             the randomization that would be endangered if we stopped the previous lipid-lowering
             agent before the enrollment

          -  abnormal AST and ALT with level ≥5 times in asymptomatic patients or ≥3 times of upper
             normal limit (UNL) in symptomatic patients

          -  pregnancy or breastfeeding

          -  on cyclosporine which had major drug interactions with pitavastatin

          -  patients who denied to join the study