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Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362726
First Posted: August 10, 2006
Last Update Posted: April 8, 2011
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.
Information provided by:
Bristol-Myers Squibb
  Purpose
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.

Condition Intervention Phase
HIV Infections Drug: Rosiglitazone maleate Drug: Atazanavir Sulphate Drug: Atazanavir Sulphate + Rosiglitazone maleate Drug: Atazanavir Sulphate + Ritonavir Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.

Secondary Outcome Measures:
  • To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir.
  • To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure

Estimated Enrollment: 14
Study Start Date: September 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Rosiglitazone maleate
Tablets, Oral, RGZ 4 mg, once daily, 1 day.
Active Comparator: B Drug: Atazanavir Sulphate
Capsules, Oral, ATV 400 mg, once daily, 5 days.
Other Name: Reyataz
Active Comparator: C Drug: Atazanavir Sulphate + Rosiglitazone maleate
Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
Other Name: Reyataz
Active Comparator: D Drug: Atazanavir Sulphate + Ritonavir
Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
Other Name: Reyataz
Active Comparator: E Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate
Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.
Other Name: Reyataz

  Eligibility

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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00362726


Locations
United States, New Jersey
Local Institution
Hamilton, New Jersey, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00362726     History of Changes
Other Study ID Numbers: AI424-106
First Submitted: August 9, 2006
First Posted: August 10, 2006
Last Update Posted: April 8, 2011
Last Verified: June 2008

Keywords provided by Bristol-Myers Squibb:
HIV

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir Sulfate
Maleic acid
Rosiglitazone
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
Hypoglycemic Agents
Physiological Effects of Drugs


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