NCT00420355

Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.

Detailed description

Thirty patients with HIV infection will be enrolled in this open-label, parallel arm pharmacokinetic study. Subjects receiving either lopinavir/ritonavir or atazanavir/ritonavir as part of their antiretroviral therapy will have a pharmacokinetic study performed over 12-20 days to examine whether coadministration of lopinavir and atazanavir alters the pharmacokinetics of either agent. The safety of these agents in combination will also be explored.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	atazanavir	Atazanavir 300 mg daily on Days 6-12.
DRUG	lopinavir/ritonavir	Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-10-01
• Completion: 2008-09-01
• First posted: 2007-01-11
• Last updated: 2009-02-06

Locations

1 site across 1 country: United States