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Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: Atazanavir (Drug); Atazanavir (Drug); Ritonavir (Drug); Ritonavir (Drug); Tenofovir (TDF) (Drug); Tenofovir (TDF) (Drug); Nucleoside Reverse Transcriptase Inhibitor (NRTI) (Drug); Nucleoside Reverse Transcriptase Inhibitor (NRTI) (Drug); Famotidine (FAM) (Drug); Famotidine (FAM) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir

Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir

Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir

Secondary outcome:

Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest

Number of Participants With Abnormalities in Vital Signs

Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings

Number of Participants With Abnormalities in Laboratory Test Results

Detailed description: This protocol was designed to compare the pharmacokinetic parameters of atazanavir administered as atazanavir/ritonavir, 400/100 mg once daily (QD), plus famotidine, 20 mg and 40 mg twice daily, with the parameters found at the usual clinical dose of atazanavir/ritonavir, 300/100 mg QD, without famotidine in HIV-infected participants receiving tenofovir disoproxil fumarate and at least 1 other nucleoside reverse transcriptase inhibitor.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Key inclusion criteria:

- 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. Key exclusion criteria:

- 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

- 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.

Locations and Contacts

Local Institution, Berlin 14050, Germany

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

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: February 2011
Last updated: August 27, 2012

Page last updated: August 23, 2015

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