Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir - Full Text View

Purpose

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.

Condition	Intervention	Phase
HIV Infections	Drug: Atazanavir+Ritonavir+Tenofovir Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Famotidine Famotidine hydrochloride Aripiprazole Tenofovir Ritonavir Atazanavir Tenofovir Disoproxil Fumarate Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.

Secondary Outcome Measures:

Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.


Estimated Enrollment:	40
Study Start Date:	April 2006
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: Atazanavir+Ritonavir+Tenofovir Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days. Other Name: Abilify
Experimental: B	Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days. Other Name: Abilify
Experimental: C	Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days. Other Name: Abilify
Experimental: D	Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days. Other Name: Abilify
Experimental: E	Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days. Other Name: Abilify

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365339

Locations


United States, New Jersey
Local Institution
Hamilton, New Jersey, United States

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 www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00365339 History of Changes
Other Study ID Numbers:	AI424-287
Study First Received:	August 16, 2006
Last Updated:	April 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:


HIV Protease Inhibitor

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Atazanavir Sulfate Ritonavir Tenofovir Famotidine Aripiprazole HIV Protease Inhibitors	Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Histamine H2 Antagonists Histamine Antagonists

ClinicalTrials.gov processed this record on September 30, 2016