Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients - Full Text View

Sponsors and Collaborators:	University of Oklahoma Abbott
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00420355

Purpose

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	Intervention	Phase
HIV Infection	Drug: atazanavir Drug: lopinavir/ritonavir	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Lopinavir Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	The Pharmacokinetics of Lopinavir/Ritonavir in Combination With Atazanavir in HIV-Infected Subjects

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Safety [ Time Frame: Day 6, Day 12 or Day 16, Day 20 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	April 2007
Estimated Study Completion Date:	June 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental 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.
Arm B: Experimental Subjects on lopinavir/ritonavir will add atazanavir.	Drug: atazanavir Atazanavir 300 mg daily on Days 6-12.

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420355

Locations

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

Sponsors and Collaborators

University of Oklahoma

Abbott

Investigators

Principal Investigator:

R. Chris Rathbun, Pharm.D.

University of Oklahoma

More Information

Responsible Party:	University of Oklahoma Health Sciences Center ( R. Chris Rathbun, Pharm.D. )
Study ID Numbers:	12637
Study First Received:	January 9, 2007
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00420355
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

antiretroviral therapy
protease inhibitors
drug interactions

HIV infection
acquired immunodeficiency syndrome
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009