Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
Information source: Ramathibodi Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; Dyslipidemia
Intervention: pitavastatin (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ramathibodi Hospital Official(s) and/or principal investigator(s): Asita Wongprikorn, Principal Investigator, Affiliation: Ramathibodi Hospital
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.
Clinical Details
Official title: Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-blind, Crossover Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy of pitavastatin in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir as measured by lipid profiles
Secondary outcome: Safety of pitavastatin in HIV-infected patients as measured by clinical and laboratory
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 2014
Last updated: May 14, 2015
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