NCT00384904
Completed
Phase 4
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects
ConditionsHIV Infections
Overview
- Phase
- Phase 4
- Intervention
- Atazanavir/Ritonavir
- Conditions
- HIV Infections
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Atazanavir plasma drug concentrations
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Arms & Interventions
A1
Intervention: Atazanavir/Ritonavir
A2
Intervention: Atazanavir/Ritonavir + Famotidine
A3
Intervention: Atazanavir/Ritonavir + Famotidine
B1
Intervention: Atazanavir/Ritonavir
B2
Intervention: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
B3
Intervention: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
Outcomes
Primary Outcomes
Atazanavir plasma drug concentrations
Time Frame: on days 10, 11, 17, 18, 24 and 25
Secondary Outcomes
- 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)
Study Sites (3)
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