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Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir

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ClinicalTrials.gov Identifier: NCT00365339
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Atazanavir+Ritonavir+Tenofovir Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects
Study Start Date : April 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Drug: Atazanavir+Ritonavir+Tenofovir
Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.
Other Name: Abilify
Experimental: B Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.
Other Name: Abilify
Experimental: C Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.
Other Name: Abilify
Experimental: D Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.
Other Name: Abilify
Experimental: E Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.
Other Name: Abilify


Outcome Measures
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Primary Outcome Measures :
  1. Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.

Secondary Outcome Measures :
  1. Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.

Eligibility Criteria
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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
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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): NCT00365339


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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00365339     History of Changes
Other Study ID Numbers: AI424-287
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: January 2009

Keywords provided by Bristol-Myers Squibb:
HIV
Protease Inhibitor

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
Tenofovir
Famotidine
Aripiprazole
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists