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A Phase 3, Single Arm, 24-Week, Multicenter Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant HIV-1

Trial Profile

A Phase 3, Single Arm, 24-Week, Multicenter Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant HIV-1

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2022

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At a glance

  • Drugs Ibalizumab (Primary)
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors TaiMed Biologics
  • Most Recent Events

    • 18 Oct 2022 Results from TMB-301 and TMB-311, characterizing complexity of OBR and assessing its impact on durability of response to IBA, presented in 24th Intl AIDS Conference
    • 12 May 2022 A systematic literature review was conducted to identify trials with designs and populations comparable to BRIGHTE, results published in the Clinical Therapeutics
    • 21 Jul 2021 Results of subgroup analysis evaluating impact of the post-attachment inhibitor ibalizumab (IBA) on weight as well as potential risk factors in treatment-experienced patients presented at the 11th International AIDS Society Conference on HIV Science
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