Overview

Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance

Status:
Not yet recruiting

Trial end date:
2027-06-01

Target enrollment:

Participant gender:

Summary

In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance. It will also assess the acceptability and swallowability of formulation among the pediatric population. The dose selection of FTR for children and adolescents ≥20kg utilized a population pharmacokinetic (POP PK) model-based approach to achieve similar adult TMR exposures following FTR 600mg BID administration with combination therapy that was demonstrated to be safe and effective in the FTR Phase 3 BRIGHTE study in HTE patients.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

PENTA Foundation

Collaborators:

Cromsource
Hospital Universitario 12 de Octubre
PHPT Foundation
ViiV Healthcare

Treatments:

Fostemsavir