drugset / Trial / NCT06139796
Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV
Phase 1/2
Withdrawn
PENTA Foundation
AMS-PHPT Research Collaboration · collabBaylor College of Medicine · collabCentre Hospitalier National d'Enfants Albert Royer · collabCentre Mère et Enfant de la Fondation Chantal Biya · collabInstitut National de la Santé Et de la Recherche Médicale, France · collabUniversity of Zimbabwe Clinical Research Centre (UZCRC) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.
Timeline
- Start
- 2025-02-01
- Primary completion
- 2025-07-09
- Completion
- 2025-07-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 120 mg | — |
| Subject | Ritonavir | Other / unclassified | 20 mg | — |