Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients
The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects|
- Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir [ Time Frame: Day 6, Day 12 or 16, Day 20 ] [ Designated as safety issue: No ]
- Safety (e.g., GI tolerance, lab abnormalities, ECG changes) [ Time Frame: Day 6, Day 12 or Day 16, Day 20 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Subjects on atazanavir/ritonavir will add lopinavir/ritonavir.
Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.
Other Name: Kaletra 200 mg/50 mg tablets
Experimental: Arm B
Subjects on lopinavir/ritonavir will add atazanavir.
Atazanavir 300 mg daily on Days 6-12.
Other Name: Reyataz 300 mg capsules
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.
|United States, Oklahoma|
|OUHSC General Clinical Research Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||R. Chris Rathbun, Pharm.D.||University of Oklahoma|