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Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Intervention: atazanavir (Drug); lopinavir/ritonavir (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Oklahoma

Official(s) and/or principal investigator(s):
R. Chris Rathbun, Pharm.D., Principal Investigator, Affiliation: University of Oklahoma

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.

Clinical Details

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

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

Primary outcome: Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir

Secondary outcome: Safety (e.g., GI tolerance, lab abnormalities, ECG changes)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

OUHSC General Clinical Research Center, Oklahoma City, Oklahoma 73104, United States
Additional Information

Starting date: April 2007
Last updated: February 5, 2009

Page last updated: August 23, 2015

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