Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients
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|ClinicalTrials.gov Identifier: NCT00420355|
Recruitment Status : Terminated (Unexpected adverse event)
First Posted : January 11, 2007
Last Update Posted : February 6, 2009
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: atazanavir Drug: lopinavir/ritonavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||September 2008|
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
- Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir [ Time Frame: Day 6, Day 12 or 16, Day 20 ]
- Safety (e.g., GI tolerance, lab abnormalities, ECG changes) [ Time Frame: Day 6, Day 12 or Day 16, Day 20 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|