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SHIELD Study

Projects

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
  • Dr 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

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