Status:
TERMINATED
Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Abbott
Conditions:
HIV Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 antir...
Eligibility Criteria
Inclusion
- HIV-seropositive
- Currently receiving atazanavir/ritonavir or lopinavir/ritonavir in combination with 2-3 nucleoside RT inhibitors or are antiretroviral treatment-naïve
- If female, is not of childbearing potential or is of childbearing potential and agrees to use a barrier method of contraception throughout the study
Exclusion
- HIV-1 RNA \> 400 copies/mL if currently receiving antiretroviral therapy
- Concurrent use of CYP450 inhibitors or inducers
- Concurrent use of P-glycoprotein substrates, inhibitors, or inducers
- Concurrent use of medications known to interact with ritonavir or atazanavir
- Presence of a chronic health condition deemed by the investigators to potentially impair lopinavir, ritonavir, or atazanavir pharmacokinetics
- Presence of conduction abnormalities on electrocardiogram
- Women who are pregnant or breastfeeding
- Laboratory Abnormalities at baseline:
- Aminotransferases \> 3x ULN
- Serum bilirubin \> 5x ULN
- Serum creatinine \> 1.5x ULN
- Hemoglobin concentration \< 8.0 g/dL
- Absolute neutrophil count \< 800 cells/μL
- Platelet count \< 50,000 cells/μL
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00420355
Start Date
April 1 2007
End Date
September 1 2008
Last Update
February 6 2009
Active Locations (1)
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1
OUHSC General Clinical Research Center
Oklahoma City, Oklahoma, United States, 73104