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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanavir+Ritonavir+Tenofovir (Drug); Atazanavir+Ritonavir+Tenofovir+Famotidine (Drug); Atazanavir+Ritonavir+Tenofovir+Famotidine (Drug); Atazanavir+Ritonavir+Tenofovir+Famotidine (Drug); Atazanavir+Ritonavir+Tenofovir+Famotidine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

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


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to

32 kg/m2

Locations and Contacts

Local Institution, Hamilton, New Jersey, United States
Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: April 2006
Last updated: April 7, 2011

Page last updated: August 23, 2015

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