Phase 4 Completed N=24 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT02442700 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcomePrimary: Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir — 239.9; 257.6; 282; 350 mg/dL — p=<0.05

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir	239.9; 257.6; 282; 350; 144.7; 146.3	<0.05 sig
SECONDARY Safety of Pitavastatin in HIV-infected Patients	38.2; 36.3; 64.6; 58.9; 39.5; 40.75	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02442700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.