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A Multi-center, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects

Trial Profile

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 28 Mar 2025

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At a glance

  • Drugs Leronlimab (Primary) ; Antiretrovirals
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PRO140
  • Sponsors CytoDyn

Most Recent Events

  • 18 Mar 2025 According to a CytoDyn media release, results in patients with multi-drug-resistant HIV was recently published by the Journal of Acquired Immune Deficiency Syndromes.
  • 01 Dec 2021 According to a CytoDyn media release, the company has completed submission of all the major sections of CMC modules to the USA FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (FDA). Only the clinical section remains to be submitted.
  • 16 Nov 2021 According to a CytoDyn media release, the company will file for expanded access use of leronlimab for a fee to MDR HIV patients who might need leronlimab urgently, possibly as soon as next week.

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