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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00384904

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Atazanavir/Ritonavir Drug: Atazanavir/Ritonavir + Famotidine Drug: Atazanavir/Ritonavir + Famotidine Drug: Atazanavir/Ritonavir Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: A1	Drug: Atazanavir/Ritonavir Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days. Other Names: Reyataz
Experimental: A2	Drug: Atazanavir/Ritonavir + Famotidine Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days. Other Names: Reyataz
Experimental: A3	Drug: Atazanavir/Ritonavir + Famotidine Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days. Other Names: Reyataz
No Intervention: B1	Drug: Atazanavir/Ritonavir Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days. Other Names: Reyataz
Experimental: B2	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. Other Names: Reyataz
Experimental: B3	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. Other Names: Reyataz

Outcome Measures

Primary Outcome Measures

Atazanavir plasma drug concentrations [on days 10, 11, 17, 18, 24 and 25]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Garden State Infectious Disease Associates, Pa	Voorhees	New Jersey	United States	08043
2	Unc Center For Aids Research	Chapel-Hill	North Carolina	United States	27599
3	Local Institution	Philadelphia	Pennsylvania	United States	19104
4	Local Institution	London	Greater London	United Kingdom	SW10 9TH