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A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

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A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 24 Feb 2020

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At a glance

  • Drugs Semzuvolimab (Primary) ; Antiretrovirals
  • Indications HIV-1 infections
  • Focus Adverse reactions; Proof of concept
  • Sponsors United BioPharma

    • Most Recent Events

    • 18 Feb 2020 Status changed from not yet recruiting to withdrawn prior to enrolment.
    • 26 Nov 2019 According to an United BioPharma (UBP) media release, NIAID will be responsible for the submission of an IND and execution of the trial
    • 26 Nov 2019 According to an United BioPharma (UBP) media release, the company announced today the signing of a clinical trial agreement with NIH/NIAID (National Institute of Allergy and Infectious Diseases) for their sponsorship of a clinical trial with UB-421 for treatment of multi-drug resistant (MDR) HIV infection.

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