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

Phase 1/2 Active not recruiting 60 enrolled PENTA Foundation Cromsource · collab Hospital Universitario 12 de Octubre · collab PHPT Foundation · collab ViiV Healthcare · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2022-06-30
Primary completion: 2028-12
Completion: 2028-12

Publications

Grasa C, Salvadori N, Nardone A, Than-In-At K, Koblansky A, Parry C, Thakkar N, Wang M, Giaquinto C, Rojo P, Cressey TR. SHIELD study: a multicenter, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in children and adolescents with HIV who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class antiretroviral (ARV) resistance. BMC Infect Dis. 2026 Feb 24;26(1):684. doi: 10.1186/s12879-026-12806-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fostemsavir	Other / unclassified	400 mg	—
Subject	Fostemsavir	Other / unclassified	600 mg	—

Indications

No indication recorded.