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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Atazanavir/Ritonavir
  • Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
• Drug: Atazanavir/Ritonavir + Famotidine
  • Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
• Drug: Atazanavir/Ritonavir + Famotidine
  • Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.
• Drug: Atazanavir/Ritonavir
  • Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.
• Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
  • Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.
• Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
  • Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: A1
• Experimental: A2
• Experimental: A3
• No Intervention: B1
• Experimental: B2
• Experimental: B3

Primary Measures

• Atazanavir plasma drug concentrations
  • Time Frame: on days 10, 11, 17, 18, 24 and 25
    

Secondary Measures

• Ritonavir plasma drug concentrations
  • Time Frame: on days 10, 11, 17, 18, 24 and 25
    
• Safety measures: Physical examinations
• ECGs
  • Time Frame: entry and discharge
    
• laboratory tests including, liver and renal function
  • Time Frame: entry, discharge and days 11, 18
    
• CD4 count
  • Time Frame: discharge
    
• HIV viral load
  • Time Frame: entry and discharge
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bristol-Myers Squibb Industry

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384904

Study ID Number: AI424-328

ClinicalTrials.gov Identifier: NCT00384904

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm