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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00384904

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 IV

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
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:

MedlinePlus related topics: AIDS

Drug Information available for: Famotidine Tenofovir Ritonavir BMS 232632 Tenofovir disoproxil Tenofovir Disoproxil Fumarate Atazanavir sulfate

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

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI424-328
Study First Received:	October 3, 2006
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00384904 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Infective Agents
HIV Protease Inhibitors
Neurotransmitter Agents
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Histamine H2 Antagonists
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Protease Inhibitors

Histamine
Virus Diseases
Anti-Retroviral Agents
Histamine Antagonists
Famotidine
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Histamine phosphate
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Neurotransmitter Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Famotidine
Therapeutic Uses
Anti-Ulcer Agents
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

Tenofovir disoproxil
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Gastrointestinal Agents
Histamine Agents
Enzyme Inhibitors
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Histamine H2 Antagonists
Protease Inhibitors

ClinicalTrials.gov processed this record on September 03, 2009