Phase 4
Completed N=25
Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection
Source: ClinicalTrials.gov NCT01232127 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir — 3512; 4131; 3322; 496 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir |
3512; 4131; 3322; 496; 602; 494 | — |
| PRIMARY Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir |
3.0; 3.0; 3.0; 4.0; 4.00; 4.0 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir |
32562; 37894; 31481; 7317; 7430; 7052 | — |
| SECONDARY Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Vital Signs |
2; 11 | — |
| SECONDARY Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings |
1; 1 | — |
| SECONDARY Number of Participants With Abnormalities in Laboratory Test Results |
1; 0; 0; 0; 1; 0 | — |
Eligibility 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 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 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.
Data sourced from ClinicalTrials.gov (NCT01232127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.