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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Atazanavir (Drug)
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.
Intervention: Ritonavir (Drug)
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.
Intervention: Tenofovir (TDF) (Drug)
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.
Intervention: Nucleoside Reverse Transcriptase Inhibitor (NRTI) (Drug)
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.
Intervention: Atazanavir (Drug)
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.
Intervention: Ritonavir (Drug)
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.
Intervention: Tenofovir (TDF) (Drug)
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.
Intervention: Nucleoside Reverse Transcriptase Inhibitor (NRTI) (Drug)
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.
Intervention: Famotidine (FAM) (Drug)
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.
Intervention: Atazanavir (Drug)
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.
Intervention: Ritonavir (Drug)
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.
Intervention: Tenofovir (TDF) (Drug)
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.
Intervention: Nucleoside Reverse Transcriptase Inhibitor (NRTI) (Drug)
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.
Intervention: Famotidine (FAM) (Drug)
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
Time Frame: 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
Time Frame: 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
Time Frame: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Secondary Outcomes
- 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.)