NCT03708861

Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.

Detailed description

The rational of this study is to save therapeutic options, toxicity and costs. The available literature shows that antiretroviral regimens that do not include a nucleoside backbone of tenofovir resulted in less bone and kidney toxicity. Atazanavir dosing 200/100 mg qd represents a simplification strategy correlated with virologic efficacy and a reduction of parameters toxicity associated. Maraviroc is suggested as a possible drug associated to PI/r in dual therapies. Even in this case, the available evidence supports the choice of the dosage of 300 mg/day.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)	Phase 1: switch from tenofovir disoproxil fumarate/emtricitabine (200/245 mg QD)+ atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD). Phase 2: switch from maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (200 /100 mg QD)

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2018-10-17
• Last updated: 2020-11-06

Locations

1 site across 1 country: Italy