Clinical trial NCT02442700: Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Dyslipidemia
Keywords: HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety of Pitavastatin in HIV-infected Patients
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ramathibodi Hospital
name: Asita Wongprikorn
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wongprikorn A, Sukasem C, Puangpetch A, Numthavej P, Thakkinstian A, Kiertiburanakul S. Effects of Pitavastatin on Lipid Profiles in HIV-Infected Patients with Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-Blind, Crossover Study. PLoS One. 2016 Jun 15;11(6):e0157531. doi: 10.1371/journal.pone.0157531. eCollection 2016.