Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00420355
• Other study ID #: 12637
• Status: Terminated
• Phase: Phase 4
• First received: January 9, 2007
• Last updated: February 5, 2009
• Start date: April 2007
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: September 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• atazanavir
Atazanavir 300 mg daily on Days 6-12.
• lopinavir/ritonavir
Lopinavir/ritonavir 400 mg/100 mg twice daily on Days 6-16, then 800 mg/200 mg daily on Days 17-21.

Locations

Country	Name	City	State
United States	OUHSC General Clinical Research Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir		Day 6, Day 12 or 16, Day 20	No
Secondary	Safety (e.g., GI tolerance, lab abnormalities, ECG changes)		Day 6, Day 12 or Day 16, Day 20	Yes