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A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial With PRO 140 in Treatment-Experienced HIV-1 Subjects

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Trial Profile

A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial With PRO 140 in Treatment-Experienced HIV-1 Subjects

Status: Suspended
Phase of Trial: Phase II/III

Latest Information Update: 07 Sep 2023

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At a glance

  • Drugs Leronlimab (Primary)
  • Indications HIV-1 infections
  • Focus Therapeutic Use
  • Sponsors CytoDyn

    • Most Recent Events

    • 30 Jun 2022 Planned End Date changed from 30 Jun 2022 to 30 Aug 2022.
    • 30 Jun 2022 Planned primary completion date changed from 30 Mar 2022 to 30 Jul 2022.
    • 30 Mar 2022 According to a CytoDyn media release, the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on Leronlimab HIV program.The partial clinical hold on the HIV program impacts patients currently enrolled in extension trials. These patients will be transitioned to other available therapeutics and no clinical studies can be initiated or resumed until the partial clinical hold is resolved.
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