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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00384904
First received: October 3, 2006
Last updated: February 3, 2010
Last verified: November 2008
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Drug: Atazanavir/Ritonavir
Drug: Atazanavir/Ritonavir + Famotidine
Drug: Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Atazanavir plasma drug concentrations [ Time Frame: on days 10, 11, 17, 18, 24 and 25 ]

Secondary Outcome 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 ]

Enrollment: 40
Study Start Date: December 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A1 Drug: Atazanavir/Ritonavir
Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.
Other Name: Reyataz
Experimental: A2 Drug: Atazanavir/Ritonavir + Famotidine
Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.
Other Name: Reyataz
Experimental: A3 Drug: Atazanavir/Ritonavir + Famotidine
Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.
Other Name: Reyataz
No Intervention: B1 Drug: Atazanavir/Ritonavir
Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.
Other Name: 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 Name: 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 Name: Reyataz

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384904

Locations
United States, New Jersey
Garden State Infectious Disease Associates, Pa
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Unc Center For Aids Research
Chapel-Hill, North Carolina, United States, 27599
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States, 19104
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW10 9TH
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00384904     History of Changes
Other Study ID Numbers: AI424-328
Study First Received: October 3, 2006
Last Updated: February 3, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Famotidine
Ritonavir
Atazanavir
Tenofovir
 Tenofovir disoproxil
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013