SHIELD Study
Infectious Diseases
Vaccine Preventable Diseases
A multicentre, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class antiretroviral (ARV) resistance.
Rationale
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 OBT that was demonstrated to be safe and effective in the FTR Phase 3 BRIGHTE study in HTE patients.
Investigators
- Dr Faeezah Patel, Principal Investigator
- Prof Lee Fairlie, Sub Investigator
- Dr Elizea Horne, Sub Investigator
- Dr Mrinmayee Dhar, Sub Investigator
- Dr Robert Kieser, Sub Investigator
- Dr Gabriella Benade, Sub Investigator
- Dr Pemphero Chasela, Sub Investigator
- Dr Muneerah Khan, Sub Investigator
- Dr Jeanne Coetzee
Latest Update
March 2024
For more details about SHIELD Study please email rhicomms@wrhi.ac.za
