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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: 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 (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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

Primary outcome: Atazanavir plasma drug concentrations

Secondary outcome:

Ritonavir plasma drug concentrations

Safety measures: Physical examinations

ECGs

laboratory tests including, liver and renal function

CD4 count

HIV viral load

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Local Institution, London, Greater London SW10 9TH, United Kingdom

Garden State Infectious Disease Associates, Pa, Voorhees, New Jersey 08043, United States

Unc Center For Aids Research, Chapel-Hill, North Carolina 27599, United States

Local Institution, Philadelphia, Pennsylvania 19104, United States

Additional Information

BMS Clinical Trials Disclosure

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

Starting date: December 2006
Last updated: February 3, 2010

Page last updated: August 23, 2015

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