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Wits RHI

SHIELD Study

Infectious Diseases
Vaccine Preventable Diseases

Project Title

SHIELD Study: Advancing Treatment Options for Children and Adolescents with Drug-Resistant HIV

Overview

The SHIELD Study is a Phase I/II clinical trial evaluating the safety, pharmacokinetics, and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in children and adolescents living with HIV-1. The study focuses on young patients who are failing current treatment and have developed resistance to multiple antiretroviral drug classes, a group with limited treatment options.

Rationale

Children and adolescents with multi-drug-resistant HIV face significant challenges in achieving and maintaining viral suppression due to limited effective treatment options. Fostemsavir, a novel antiretroviral agent, has demonstrated safety and efficacy in heavily treatment-experienced adults. This study extends that research to younger populations by:

  • Identifying appropriate dosing strategies for children based on body weight
  • Evaluating whether similar drug exposure and effectiveness can be achieved as seen in adults
  • Addressing a critical unmet need for new treatment options in paediatric HIV care

The study aims to provide evidence to support the use of fostemsavir in children and adolescents who have limited or no remaining effective therapies.

Study Aim

To determine whether fostemsavir, in combination with optimized background therapy, is safe, effective, and suitable for children and adolescents with drug-resistant HIV, and to expand treatment options for this vulnerable population.

Primary Objectives

  • Evaluate the safety of fostemsavir-based treatment over 24 weeks
  • Assess the pharmacokinetics of temsavir in children and adolescents

Secondary Objectives

  • Evaluate antiviral activity at 24 and 48 weeks
  • Assess long-term safety (up to 156 weeks)
  • Monitor disease progression and treatment outcomes
  • Evaluate immune response (CD4+ T-cell changes)
  • Assess drug resistance patterns
  • Evaluate acceptability and swallowability of treatment

Investigators

  • Dr Faeezah Patel – Principal Investigator
  • Prof Lee Fairlie – Sub-Investigator
  • Dr Elizea Horne – Sub-Investigator
  • Dr Mrinmayee Dhar – Sub-Investigator
  • Dr Jeanne Coetzee – Sub-Investigator

Latest Update: March 2026

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

Project Brief

SHIELD Study