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

August 16, 2016 updated by: Asita Wongprikorn, Ramathibodi Hospital

Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-blind, Crossover Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: pitavastatin
Treatment A = administration pitavastatin for 12 weeks
Other Names:
  • Livalo
Drug: placebo
Treatment B = administration placebo for 12 weeks
Experimental: 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
Drug: pitavastatin
Treatment A = administration pitavastatin for 12 weeks
Other Names:
  • Livalo
Drug: placebo
Treatment B = administration placebo for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
Time Frame: 12 weeks
Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Pitavastatin in HIV-infected Patients
Time Frame: 12 weeks

Safety clinical was defined by FDA; grade 1 mild symptoms; grade 2 moderate symptoms with limiting age-appropriate IADL; grade 3 severe symptoms with limiting self-care ADL, But not immediately life-threatening; grade 4 life-threatening consequences; and grade 5 death related to adverse event.

Safety laboratory evaluation was determined safe if AST, ALT, and/or CPK level was not increased significantly comparing pitavastatin to placebo.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Asita Wongprikorn, Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

May 10, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ramathibodi Hospital 01-57-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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