Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine

Drug: Atazanavir/Ritonavir + Famotidine

Drug: Atazanavir/Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00384904

AI424-328

Details and patient eligibility

About

The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²
Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA <400 copies/mL and have CD4 count >200 cells/mm³