A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV
- Tuberculosis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Subjects will receive once-daily Biktarvy for 4 weeks to ensure all moieties of interest reach steady-state prior to the baseline PK assessment. Thereafter, subjects will be enrolled in one of two groups for PK analysis as follows: Group one will continue Biktarvy and have rifapentine dosed daily fo...
Subjects will receive once-daily Biktarvy for 4 weeks to ensure all moieties of interest reach steady-state prior to the baseline PK assessment. Thereafter, subjects will be enrolled in one of two groups for PK analysis as follows: Group one will continue Biktarvy and have rifapentine dosed daily for 4 weeks (10 mg/kg; 600mg dose). Group two will continue Biktarvy and have rifapentine dosed weekly for 4 weeks (15 mg/kg; 900mg dose). After 4 weeks of Biktarvy dosing, subjects will have a baseline intensive PK of plasma bictegravir (BIC), tenofovir alafenamide (TAF), tenofovir (TFV) levels at all time points, and peripheral blood mononuclear cells (PBMCs) will be collected at 24 hours post-dose for IC TFV-DP. This will occur prior to receiving their first dose of directly observed oral rifapentine co-administered with Biktarvy, thus serving as their own control. Rifapentine will thereafter be administered by directly observed therapy (DOT) or ingestion monitored by smart phone application (e.g., Time Stamp App or other phone app platform). Intensive PK assessments will be repeated after 4 weeks of RPT dosing for both Group 1 and 2. Intensive PK sampling will be performed at time 0 (pre-dose), 15 and 30 min; 1, 2, 3, 4, 8, 12 and 24 hours post-dose with BIC/TAF/FTC alone and when coadministered with rifapentine. Plasma will be isolated at all time points, and PBMCs will be isolated at 24 hours post-dose. PK levels will be measured by colleagues at the Colorado Antiviral Pharmacology (CAVP) Laboratory at the University of Colorado Anschutz Medical Campus. Plasma concentrations of BIC, TAF, TFV, and IC TFV-DP in PBMCs will be measured by liquid chromatography-tandem mass spectrometry.
Tracking Information
- NCT #
- NCT04551573
- Collaborators
- Gilead Sciences
- Investigators
- Principal Investigator: Onyema Ogbuagu, MBBCh, FACP Yale University