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

This study has been completed.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: August 16, 2006
Last updated: April 7, 2011
Last verified: January 2009
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 Intervention Phase
HIV Infections
Drug: Atazanavir+Ritonavir+Tenofovir
Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

Estimated Enrollment: 40
Study Start Date: April 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00365339

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00365339     History of Changes
Other Study ID Numbers: AI424-287 
Study First Received: August 16, 2006
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Protease Inhibitor

Additional relevant MeSH terms:
Atazanavir Sulfate
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Anti-Ulcer Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
HIV Protease Inhibitors
Histamine Agents
Histamine Antagonists
Histamine H2 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Protease Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on May 25, 2016