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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384904
• Other study ID #: AI424-328
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2006
• Last updated: February 3, 2010
• Start date: December 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Local Institution	London	Greater London
United States	Unc Center For Aids Research	Chapel-Hill	North Carolina
United States	Local Institution	Philadelphia	Pennsylvania
United States	Garden State Infectious Disease Associates, Pa	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atazanavir plasma drug concentrations		on days 10, 11, 17, 18, 24 and 25
Secondary	Ritonavir plasma drug concentrations		on days 10, 11, 17, 18, 24 and 25
Secondary	Safety measures: Physical examinations
Secondary	ECGs		entry and discharge
Secondary	laboratory tests including, liver and renal function		entry, discharge and days 11, 18
Secondary	CD4 count		discharge
Secondary	HIV viral load		entry and discharge

External Links

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