Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Other, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Atazanavir plasma drug concentrations
Secondary outcome: Ritonavir plasma drug concentrationsSafety 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
Ending date: December 2007
Last updated: June 12, 2008
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