Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

NCT ID: NCT02442700

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-01-31

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.

Conditions

HIV; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment sequence A, B

Treatment visits were seperated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks

Group Type: EXPERIMENTAL

pitavastatin

Intervention Type: DRUG

Treatment A = administration pitavastatin for 12 weeks

placebo

Intervention Type: DRUG

Treatment B = administration placebo for 12 weeks

Treatment sequence B, A

Treatment visits were seperated by a 2-week washout period. Treatment B = adminstration placebo for 12 weeks; Treatment A = adminstration pitavastatin for 12 weeks

Group Type: EXPERIMENTAL

pitavastatin

Intervention Type: DRUG

Treatment A = administration pitavastatin for 12 weeks

placebo

Intervention Type: DRUG

Treatment B = administration placebo for 12 weeks

Interventions

pitavastatin

Treatment A = administration pitavastatin for 12 weeks

Intervention Type: DRUG

placebo

Treatment B = administration placebo for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Livalo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramathibodi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Asita Wongprikorn

Ramathibodi Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asita Wongprikorn

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

References

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.

Reference Type: DERIVED

PMID: 27304841 (View on PubMed)

Other Identifiers

Ramathibodi Hospital 01-57-18

Identifier Type: -

Identifier Source: org_study_id