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

HIV Clinical Trial

Official title:

Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-blind, Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442700
• Other study ID #: Ramathibodi Hospital 01-57-18
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2015
• Last updated: May 14, 2015
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ramathibodi Hospital:Thailand
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• HIV

Intervention

Drug:
• pitavastatin
give for the first 12 weeks in arm A, and late 12 weeks in arm B
• placebo
give for the first 12 weeks in arm B, and late 12 weeks in arm A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of pitavastatin in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir as measured by lipid profiles	lipid profile change after receiving pitavastatin compared with placebo	12 weeks	No
Secondary	Safety of pitavastatin in HIV-infected patients as measured by clinical and laboratory	change of AST, ALT, and CPK after receiving pitavastatin compared with placebo	12 weeks	Yes