Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Ramathibodi Hospital


Information provided by (Responsible Party)
Asita Wongprikorn, Ramathibodi Hospital

ClinicalTrials.gov Identifier
NCT02442700

First received: February 25, 2015
Last updated: August 16, 2016
Last Verified: August 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV
Dyslipidemia

Drug : pitavastatin
Drug : placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-blind, Crossover Study

Further study details as provided by Asita Wongprikorn, Ramathibodi Hospital:

Primary Outcome Measures

  • 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.
Secondary Outcome Measures:
  • 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.

Enrollment: 24
Study Start Date: May 2014
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: Livalo
Drug: placebo

Treatment B = administration placebo for 12 weeks

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02442700

Sponsors and Collaborators

Ramathibodi Hospital

Investigators

Principal Investigator: Asita Wongprikorn Ramathibodi Hospital
More Information

More Information


Responsible Party: Asita Wongprikorn, Ramathibodi Hospital, Ramathibodi Hospital  
ClinicalTrials.gov Identifier: NCT02442700   History of Changes  
Other Study ID Numbers: Ramathibodi Hospital 01-57-18  
Study First Received: February 25, 2015  
Last Updated: August 16, 2016  

Keywords provided by Asita Wongprikorn, Ramathibodi Hospital:

HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir

Additional relevant MeSH terms:
Dyslipidemias
Ritonavir
Atazanavir Sulfate
Pitavastatin

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.