Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
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
Sponsored by: Bristol-Myers Squibb
Official(s) and/or principal investigator(s):
Jenny Zhang, PhD, 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
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: Other, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
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.
- Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to
Locations and Contacts
Local Institution, Hamilton, New Jersey, United States
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: June 6, 2008