drugset / Trial / NCT05993767
UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children
Phase 2
Completed
53 enrolled
PENTA Foundation
Baylor College of Medicine · collabChiang Mai University · collabClinton Health Access Initiative Inc. · collabJoint Clinical Research Center · collabRadboud University Medical Center · collabUniversity of Zimbabwe · collab
NaSingle-groupOpen-labelTreatment
Summary
This study aims to find out whether treating children living with HIV with three anti-HIV medicines, dolutegravir (DTG), emtricitabine (FTC) and tenofovir alafenamide (TAF), with a novel dose ratio will achieve adequate drug concentrations and is safe. The optimal DTG/FTC/TAF dose ratio will be used for the development of a fixed-dose combination dispersible tablet.
Timeline
- Start
- 2024-12-11
- Primary completion
- 2025-06-30
- Completion
- 2026-01-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | 10 mg | — |
| Subject | Dolutegravir | Other / unclassified | 50 mg | — |
| Subject | emtricitabine | Other / unclassified | 15 mg | — |
| Subject | emtricitabine | Other / unclassified | 200 mg | — |
| Subject | tenofovir alafenamide | Small molecule | 1.88 mg | — |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | — |