Trial reportBMC infectious diseases2026
SHIELD study: a multicenter, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in children and adolescents with HIV who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class antiretroviral (ARV) resistance.
Trial report in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04648280 (A Multicenter, Open-label, Single-arm Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Fostemsavir in Combination With Optimized Background Therapy), which is not on this map. Not yet cited in PubMed.
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A Multicenter, 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
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11 authors.
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Abstract
backgroundMulti-drug resistant HIV-1 is a growing global concern in children, highlighting the need for new antiretroviral drugs. Fostemsavir, recently approved for adults with multi-drug resistant HIV-1 and limited treatment options, has not yet been evaluated in the pediatric population. The SHEILD protocol was developed to assess this missing research gap.
methodsThe SHIELD study is a multicenter, phase I/II, open-label, single-arm trial evaluates the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in children and adolescents with HIV-1 who are failing their current combination antiretroviral therapy and have at least dual-class resistance. Participants will receive weight-based fostemsavir dosing: 400 mg twice daily for participants ≥20 to < 35 kg, and 600 mg twice daily for those ≥35 kg. It is planned to recruit at least 28 evaluable participants, including at least 8 participants under 12 years old weighing ≥20 kg to < 35 kg, of whom at least 4 must weigh ≥20 to < 25 kg. Participants will be treated for a minimum of 24 weeks, with safety follow-up continuing to 48 weeks. It is planned that those children benefiting from fostemsavir treatment may continue for up to 156 weeks to assess long-term safety. DISCUSSION: This registrational trial will generate data supporting the approval of fostemsavir for pediatric patients aged ≥6 years and weighing ≥20 kg.
trial registrationProtocol number: PENTA 22/ViiV 212,968. EudraCT: 2020-001029-30. Clinicaltrials.gov: NCT04648280; Registration date: 11 November 2020.
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