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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2007

Last Updated Date

February 5, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir

Change History

Complete list of historical versions of study NCT00420355 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

safety

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

Official Title ^ICMJE

The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00420355

Other Study ID Numbers ^ICMJE

12637

Has Data Monitoring Committee

Responsible Party

R. Chris Rathbun, Pharm.D., University of Oklahoma Health Sciences Center

Study Sponsor ^ICMJE

University of Oklahoma

Collaborators ^ICMJE

Abbott

Investigators ^ICMJE

Principal Investigator:

R. Chris Rathbun, Pharm.D.

University of Oklahoma

Information Provided By

University of Oklahoma

Verification Date

February 2009

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

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