HIV Infections
Conditions
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.
Interventions
Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
DRUGAtazanavir/Ritonavir + Famotidine
Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
DRUGAtazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atazanavir plasma drug concentrations | on days 10, 11, 17, 18, 24 and 25 |
Secondary
| Measure | Time frame |
|---|---|
| Safety measures: Physical examinations | — |
| ECGs | entry and discharge |
| Ritonavir plasma drug concentrations | on days 10, 11, 17, 18, 24 and 25 |
| CD4 count | discharge |
| HIV viral load | entry and discharge |
| laboratory tests including, liver and renal function | entry, discharge and days 11, 18 |
Countries
United Kingdom, United States
Outcome results
None listed