Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
Phase 4
Completed
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00384904
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B3 Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine - A1 Atazanavir/Ritonavir - A2 Atazanavir/Ritonavir + Famotidine - A3 Atazanavir/Ritonavir + Famotidine - B1 Atazanavir/Ritonavir - B2 Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine -
- Primary Outcome Measures
Name Time Method Atazanavir plasma drug concentrations on days 10, 11, 17, 18, 24 and 25
- Secondary Outcome Measures
Name Time Method Ritonavir plasma drug concentrations on days 10, 11, 17, 18, 24 and 25 Safety measures: Physical examinations ECGs entry and discharge laboratory tests including, liver and renal function entry, discharge and days 11, 18 CD4 count discharge HIV viral load entry and discharge
Trial Locations
- Locations (3)
Local Institution
🇬🇧London, Greater London, United Kingdom
Garden State Infectious Disease Associates, Pa
🇺🇸Voorhees, New Jersey, United States
Unc Center For Aids Research
🇺🇸Chapel-Hill, North Carolina, United States