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Wits RHI

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 with Dual- or Triple-Class Antiretroviral Resistance.

Rationale

Children and adolescents with limited treatment options due to dual- or triple-class antiretroviral resistance require innovative regimens. Fostemsavir, shown to be effective in heavily treatment-experienced adults in the Phase 3 BRIGHTE study, is being evaluated in this paediatric population. Population pharmacokinetic modelling supports dosing strategies designed to mirror adult exposure, enabling the assessment of safety and efficacy in this critical group.

Primary Objective

  • To evaluate the safety of 24 weeks of treatment with fostemsavir + OBT in HIV-1 infected children and adolescents (ages 6 to <18 years; ≥20kg in weight) who are failing current cART and have dual- or triple-class ARV resistance.

  • To evaluate steady-state pharmacokinetics of temsavir (active moiety of fostemsavir).

Study Population & Sample Size

  • Target group: HIV-1 positive children/adolescents aged 6–<18 years, ≥20kg in weight

  • Sample size: Minimum 60 participants

    • ≥50 participants in ≥35kg group

    • ≥10 participants in 20–<35kg group

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, Sub-Investigator

Latest Update

March 2024

For more details about SHIELD Study please email rhicomms@wrhi.ac.za

Research Brief

SHIELD Study