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

NCT02442700 | Completed Phase 4 Results

• 1 other identifier: Ramathibodi Hospital 01-57-18
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Keywords

HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir

Outcome Measures

Primary Outcomes (1)

• Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir

  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 Outcomes (1)

• Safety of Pitavastatin in HIV-infected Patients

  12 weeks

Study Arms (2)

Treatment sequence A, B

EXPERIMENTAL

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; Drug: placebo

Treatment sequence B, A

EXPERIMENTAL

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; Drug: placebo

Interventions

pitavastatin DRUG

Treatment A = administration pitavastatin for 12 weeks

Also known as: Livalo

Treatment sequence A, B; Treatment sequence B, A

placebo DRUG

Treatment B = administration placebo for 12 weeks

Treatment sequence A, B; Treatment sequence B, A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Related Publications (1)

• 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.

  PMID: 27304841 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

LImitation of this study is we did not adjust pitavastatin dosage according to lipid profiles,thus mean value of TC could not be lower than 200 mg/dL.

Results Point of Contact

• Title: Asita Wongprikorn, MD
• Organization: Ramathibodi Hospital, Mahidol University

wongprikorn@yahoo.com

664236949

Study Officials

• Asita Wongprikorn

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ramathibodi Hospital

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: May 13, 2015
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 10, 2016
• Results First Posted: October 10, 2016

Record last verified: 2016-08