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

Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00365339

Enrollment

Registered

2006-08-17

Start date

2006-04-30

Completion date

2006-06-30

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Protease Inhibitor

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.

Interventions

DRUGAtazanavir+Ritonavir+Tenofovir

Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.

DRUGAtazanavir+Ritonavir+Tenofovir+Famotidine

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026