Clinical Trial

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

Active, Not Recruiting Phase 1/2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-11-23; most recent amendment 2026-03-03.
Status change: Recruiting → Active, Not Recruiting 2026-03-03
Status change: Not Yet Recruiting → Recruiting 2023-03-28
Trial Details
NCT Number NCT04648280
Lead Sponsor PENTA Foundation
Collaborators: ViiV Healthcare, PHPT Foundation, Hospital Universitario 12 de Octubre, Cromsource
Conditions HIV Infections With Multi Drug Resistant Virus
Enrollment 60 participants
Start Date 2022-06-30
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-05