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

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2018

At a glance

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

    • 07 Mar 2018 Results presented at the 25th Conference on Retroviruses and Opportunistic Infections
    • 07 Mar 2018 Results presented in the Theratechnologies media release.
    • 06 Mar 2018 According to a Theratechnologies media release, Based on the data from this trial, the U.S. Food and Drug Administration (FDA) has approved ibalizumab (Trogarzo) in combination with other antiretroviral treatments (ARTs) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
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