Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

Stopped early · Phase 4

Conditions studied: HIV Infection

In brief

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

Key facts

Study ID

NCT00420355

Run by

University of Oklahoma

People needed

19

Starts

2007-04-01

Expected to finish

2008-09-01

Last updated by the study team

2009-02-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• OUHSC General Clinical Research Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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