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A Registration-Directed Study to Investigate Leronlimab Single-Agent Maintenance Therapy for HIV-Infected Patients

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Trial Profile

A Registration-Directed Study to Investigate Leronlimab Single-Agent Maintenance Therapy for HIV-Infected Patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 23 May 2024

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At a glance

  • Drugs Leronlimab (Primary)
  • Indications HIV infections
  • Focus Registrational; Therapeutic Use
  • Sponsors CytoDyn

Most Recent Events

  • 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.
  • 30 Mar 2022 Status changed from planning to suspended, according to a CytoDyn media release.
  • 20 Nov 2018 According to a CytoDyn media release, the company is hopeful to have final approval for treating with leronlimab monotherapy in 2020.

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