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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine; Drug: Atazanavir+Ritonavir+Tenofovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365339

AI424-287

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Trial design

40 participants in 5 patient groups

A

Active Comparator group

Treatment:

Drug: Atazanavir+Ritonavir+Tenofovir

B

Experimental group

Treatment:

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

C

Experimental group

Treatment:

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

D

Experimental group

Treatment:

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

E

Experimental group

Treatment:

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine