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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420355
|United States, Oklahoma|
|OUHSC General Clinical Research Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||R. Chris Rathbun, Pharm.D.||University of Oklahoma|