Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

This study has been terminated.
(Unexpected adverse event)
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00420355
First received: January 9, 2007
Last updated: February 5, 2009
Last verified: February 2009

January 9, 2007
February 5, 2009
April 2007
October 2007   (final data collection date for primary outcome measure)
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 ]
mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir
Complete list of historical versions of study NCT00420355 on ClinicalTrials.gov Archive Site
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 ]
safety
Not Provided
Not Provided
 
Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients
The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects

The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: atazanavir
    Atazanavir 300 mg daily on Days 6-12.
    Other Name: Reyataz 300 mg capsules
  • Drug: 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 A
    Subjects on atazanavir/ritonavir will add lopinavir/ritonavir.
    Intervention: Drug: lopinavir/ritonavir
  • Experimental: Arm B
    Subjects on lopinavir/ritonavir will add atazanavir.
    Intervention: Drug: atazanavir
Rathbun CR, Liedtke MD, Blevins SM, Harrison D, Lockhart SM, Salvaggio M, Acosta EP. Electrocardiogram abnormalities with atazanavir and lopinavir/ritonavir. HIV Clin Trials. 2009 Sep-Oct;10(5):328-36.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
September 2008
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00420355
12637
No
R. Chris Rathbun, Pharm.D., University of Oklahoma Health Sciences Center
University of Oklahoma
Abbott
Principal Investigator: R. Chris Rathbun, Pharm.D. University of Oklahoma
University of Oklahoma
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP