Conditions: HIV
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

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.

Arms:
arm 1: The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs. arm 2: FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs. arm 3: FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.

Interventions: intervention 1: Atazanavir intervention 2: Atazanavir intervention 3: Ritonavir intervention 4: Ritonavir intervention 5: Tenofovir (TDF) intervention 6: Tenofovir (TDF) intervention 7: Nucleoside Reverse Transcriptase Inhibitor (NRTI) intervention 8: Nucleoside Reverse Transcriptase Inhibitor (NRTI) intervention 9: Famotidine (FAM) intervention 10: Famotidine (FAM)
Intervention descriptions: intervention 1: Capsule, oral, 300 mg, once daily, 10 days intervention 2: Capsule, oral, 400 mg, once daily, 7 days intervention 3: Capsule, oral, 100 mg, once daily, 10 days intervention 4: Capsule, oral, 100 mg, once daily, 7 days intervention 5: Capsule, oral, 300 mg, once daily, 10 days intervention 6: Capsule, oral, 300 mg, once daily, 7 days intervention 7: Oral, 10 days intervention 8: Oral, 7 days intervention 9: Tablet, oral, 20 mg, twice daily, 7 days intervention 10: Tablet, oral, 40 mg, twice daily, 7 days

Protocol document: