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: 31 Jul 2018

At a glance

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

    • 31 Jul 2018 According to a Theratechnologies media release,the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) will review the application for marketing authorization of Trogarzo(ibalizumab-uiyk) injection under the accelerated assessment procedure.The accelerated assessment procedure reduces the timeframe for a recommendation by the CHMP to 150 review days from 210 review days for the normal procedure.
    • 24 Apr 2018 According to a Theratechnologies media release, the company will seek regulatory approval from the European Medicines Agency for ibalizumab (Trogarzo™) for HIV-1 infection using efficacy and safety data from this clinical trial.
    • 07 Mar 2018 Results presented at the 25th Conference on Retroviruses and Opportunistic Infections
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