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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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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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs Fostemsavir (Primary) ; Antiretrovirals
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms SHIELD study

    • Most Recent Events

    • 03 Apr 2024 Planned End Date changed from 1 Jun 2027 to 1 Jun 2028.
    • 03 Apr 2024 Planned primary completion date changed from 1 Jun 2024 to 1 Jun 2025.
    • 13 Aug 2021 Status changed from not yet recruiting to recruiting.

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