Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine on the Pharmacokinetics of Atazanavir in HIV-Infected Subjects Receiving Atazanavir With Ritonavir and Tenofovir
2 other identifiers
interventional
25
2 countries
2
Brief Summary
The purpose of this study is to assess the effects of famotidine, given twice daily, on atazanavir administered with ritonavir and tenofovir in HIV-infected participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 hiv
Started Feb 2011
Shorter than P25 for phase_4 hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
August 28, 2012
CompletedAugust 31, 2012
August 1, 2012
4 months
October 29, 2010
July 23, 2012
August 27, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir
Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir
Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Secondary Outcomes (4)
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Vital Signs
Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.
Number of Participants With Abnormalities in Laboratory Test Results
Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Study Arms (3)
Atazanavir/ritonavir (300/100 mg) + TDF + ≥ 1 NRTI
OTHERThe protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20)
OTHERFAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)
OTHERFAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Interventions
Capsule, oral, 300 mg, once daily, 10 days
Capsule, oral, 100 mg, once daily, 10 days
Capsule, oral, 300 mg, once daily, 10 days
Oral, 10 days
Tablet, oral, 20 mg, twice daily, 7 days
Eligibility Criteria
You may qualify if:
- Males and females, 18 to 65 years of age, with HIV infection and a body mass index of 18.0 to 35.0 kg/m\^2
- HIV-infected participants receiving a treatment regimen containing only atazanavir/ritonavir, 300/100 mg once daily (QD) + tenofovir, 300 mg QD + at least 1 other nucleotide reverse transcriptase inhibitor continuously for at least 3 months prior to study day 1
- Plasma HIV RNA levels of \<50 copies/mL and a CD4 count \>200 cells/mm\^3.
- No history of virologic failure on a protease inhibitor (PI), documented phenotypic PI resistance, or primary PI mutations, according to International AIDS Society recommendations
- No documented phenotypic resistance to atazanavir or primary genotypic mutations causing resistance to atazanavir
- Women of childbearing potential who were not nursing or pregnant and were using an acceptable method of contraception for at least 4 weeks before dosing, during the study, and for 8 weeks from the last dose of study drug.
- Women with a negative pregnancy test result within 24 hours prior to dosing with study medication
- Women not breastfeeding
- Men willing or able to agree to practice barrier contraception for the duration of the study and at least 3 months after dosing.
You may not qualify if:
- Any history of CD4 cell count \<50 cells/mm\^3
- Previously documented phenotypic or genotypic resistance to any of the currently prescribed NRTIs
- Any significant acute illness within 6 months of study day 1 or chronic medical illness unless stable or controlled by a nonprohibited medication
- Any major surgery within 4 weeks of study day 1
- Any gastrointestinal surgery that could impact upon the absorption of any study drug
- Inability to be venipunctured and/or tolerate venous access
- History of Gilbert's syndrome, hemophilia, chronic pancreatitis, hypochlorhydria, achlorhydria, clinically relevant gastroesophageal reflux disease, hiatal hernia, or peptic/gastric ulcer disease
- Intractable diarrhea (≥ 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study day 1
- Recent (within 6 months prior to study day 1) drug or alcohol abuse
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations, which would not be expected for the extent of HIV disease
- Any of the following on 12-lead ECG prior to dosing on study day 1, confirmed by repeat: PR ≥ 210 msec; QRS ≥ 120 msec; QT ≥ 500 msec; QTcF ≥ 450 msec
- Second- or third-degree A-V block or clinically relevant ECG abnormalities
- Creatinine clearance, as estimated by method of Cockcroft and Gault, less than 60 mL/min
- Liver enzyme levels \> 3\* the upper limit of normal (ULN) prior to dosing on study day 1
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Local Institution
Berlin, 14050, Germany
Local Institution
London, Greater London, SW10 9NH, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BMS Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 2, 2010
Study Start
February 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 31, 2012
Results First Posted
August 28, 2012
Record last verified: 2012-08