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Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420355
Recruitment Status : Terminated (Unexpected adverse event)
First Posted : January 11, 2007
Last Update Posted : February 6, 2009
Information provided by:
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: atazanavir Drug: lopinavir/ritonavir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects
Study Start Date : April 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Arm A
Subjects on atazanavir/ritonavir will add lopinavir/ritonavir.
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 B
Subjects on lopinavir/ritonavir will add atazanavir.
Drug: atazanavir
Atazanavir 300 mg daily on Days 6-12.
Other Name: Reyataz 300 mg capsules

Primary Outcome Measures :
  1. Mean pharmacokinetic parameters (Cmax, Cmin, AUC) for lopinavir, ritonavir, atazanavir [ Time Frame: Day 6, Day 12 or 16, Day 20 ]

Secondary Outcome Measures :
  1. Safety (e.g., GI tolerance, lab abnormalities, ECG changes) [ Time Frame: Day 6, Day 12 or Day 16, Day 20 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00420355

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United States, Oklahoma
OUHSC General Clinical Research Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
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Principal Investigator: R. Chris Rathbun, Pharm.D. University of Oklahoma
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: R. Chris Rathbun, Pharm.D., University of Oklahoma Health Sciences Center Identifier: NCT00420355    
Other Study ID Numbers: 12637
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009
Keywords provided by University of Oklahoma:
antiretroviral therapy
protease inhibitors
drug interactions
HIV infection
acquired immunodeficiency syndrome
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors