Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: Abbott
• Treatments: Atazanavir Sulfate; HIV Protease Inhibitors; Lopinavir; Protease Inhibitors; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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