Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
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.