Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

Phase 4

Terminated

• Conditions: HIV Infection
• Interventions: Drug: lopinavir/ritonavir; Drug: atazanavir

• Registration Number: NCT00420355
• Lead Sponsor: University of Oklahoma

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 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.

Study Timeline

• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Study First Posted: 2007-01-11
• Study Start: 2007-04
• Primary Completion: 2007-10
• Study Completion: 2008-09
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-05
• Last Update Posted: 2009-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	lopinavir/ritonavir	Subjects on atazanavir/ritonavir will add lopinavir/ritonavir.
Arm B	atazanavir	Subjects on lopinavir/ritonavir will add atazanavir.

Primary Outcome Measures

Name	Time	Method
Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir	Day 6, Day 12 or 16, Day 20

Secondary Outcome Measures

Name	Time	Method
Safety (e.g., GI tolerance, lab abnormalities, ECG changes)	Day 6, Day 12 or Day 16, Day 20

Trial Locations

Locations (1)

OUHSC General Clinical Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States