Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection
NCT ID: NCT01232127
Last Updated: 2012-08-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2011-02-28
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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Atazanavir/ritonavir (300/100 mg) + TDF + ≥ 1 NRTI
The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Atazanavir
Capsule, oral, 300 mg, once daily, 10 days
Ritonavir
Capsule, oral, 100 mg, once daily, 7 days
Tenofovir (TDF)
Capsule, oral, 300 mg, once daily, 10 days
Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Oral, 10 days
Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (20)
FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Atazanavir
Capsule, oral, 400 mg, once daily, 7 days
Ritonavir
Capsule, oral, 100 mg, once daily, 10 days
Tenofovir (TDF)
Capsule, oral, 300 mg, once daily, 7 days
Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Oral, 7 days
Famotidine (FAM)
Tablet, oral, 20 mg, twice daily, 7 days
Atazanavir/ritonavir (400/100) + TDF + ≥1 NRTI + FAM (40)
FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Atazanavir
Capsule, oral, 400 mg, once daily, 7 days
Ritonavir
Capsule, oral, 100 mg, once daily, 10 days
Tenofovir (TDF)
Capsule, oral, 300 mg, once daily, 7 days
Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Oral, 7 days
Famotidine (FAM)
Tablet, oral, 40 mg, twice daily, 7 days
Interventions
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Atazanavir
Capsule, oral, 300 mg, once daily, 10 days
Atazanavir
Capsule, oral, 400 mg, once daily, 7 days
Ritonavir
Capsule, oral, 100 mg, once daily, 10 days
Ritonavir
Capsule, oral, 100 mg, once daily, 7 days
Tenofovir (TDF)
Capsule, oral, 300 mg, once daily, 10 days
Tenofovir (TDF)
Capsule, oral, 300 mg, once daily, 7 days
Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Oral, 10 days
Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Oral, 7 days
Famotidine (FAM)
Tablet, oral, 20 mg, twice daily, 7 days
Famotidine (FAM)
Tablet, oral, 40 mg, twice daily, 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Positive urine screen for drugs of abuse at screening or prior to dosing without a valid prescription. Positive urine drug screen for cannabinoids with or without a prescription is not exclusionary
* 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
* Total bilirubin level \>10\*ULN prior to study day 1
* Positive blood screen for hepatitis B surface antigen or hepatitis C antibody.
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Berlin, , Germany
Local Institution
London, Greater London, United Kingdom
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2009-016981-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI424-398
Identifier Type: -
Identifier Source: org_study_id