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

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

MedlinePlus related topics:

AIDS

Drug Information available for:

Ritonavir Atazanavir sulfate BMS 232632 Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Famotidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, 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

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 ]

Estimated Enrollment:	36
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	Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI424-328
First Received:	October 3, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00384904
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Acquired Immunodeficiency Syndrome

Atazanavir

Immunologic Deficiency Syndromes

Histamine

Virus Diseases

Famotidine

HIV Infections

Ritonavir

Sexually Transmitted Diseases

Histamine phosphate

Tenofovir

Retroviridae Infections

Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents

HIV Protease Inhibitors

RNA Virus Infections

Neurotransmitter Agents

Anti-HIV Agents

Slow Virus Diseases

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Physiological Effects of Drugs

Gastrointestinal Agents

Histamine Agents

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Histamine H2 Antagonists

Reverse Transcriptase Inhibitors

Protease Inhibitors

Anti-Retroviral Agents

Histamine Antagonists

Therapeutic Uses

Anti-Ulcer Agents

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 29, 2008

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