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

Information source: Ramathibodi Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV; Dyslipidemia

Intervention: pitavastatin (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ramathibodi Hospital

Official(s) and/or principal investigator(s):
Asita Wongprikorn, Principal Investigator, Affiliation: Ramathibodi Hospital


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Efficacy of pitavastatin in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir as measured by lipid profiles

Secondary outcome: Safety of pitavastatin in HIV-infected patients as measured by clinical and laboratory


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: May 2014
Last updated: May 14, 2015

Page last updated: August 23, 2015

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