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Extension of Protocol PRO140_CD01 to Evaluate Long-term Suppression of HIV-1 Replication Following Substitution of Stable Combination ART With PRO 140 (Monoclonal CCR5 Antibody) Monotherapy for Additional 160 Weeks in Adult Subjects w/ HIV-1

Trial Profile

Extension of Protocol PRO140_CD01 to Evaluate Long-term Suppression of HIV-1 Replication Following Substitution of Stable Combination ART With PRO 140 (Monoclonal CCR5 Antibody) Monotherapy for Additional 160 Weeks in Adult Subjects w/ HIV-1

Status: Active, no longer recruiting
Phase of Trial: Phase II

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

    • 12 Apr 2022 According to CytoDyn Media Release, results assessing virological and immunological consequences of Leronlimab in chronically CCR5-tropic HIV-1 infected humans (n = 5) on suppressive antiretroviral therapy (ART) and in ART-naive acutely CCR5-tropic SHIV infected rhesus macaques (n = 4) using data from 2 trials (NCT02175680 and NCT02355184) published as peer reviewed paper in the open-access journal PLOS Pathogens.
    • 12 Apr 2022 Results assessing virological and immunological consequences of Leronlimab in chronically CCR5-tropic HIV-1 infected humans (n = 5) on suppressive antiretroviral therapy (ART) and in ART-naive acutely CCR5-tropic SHIV infected rhesus macaques (n = 4) using data from 2 trials (NCT02175680 and NCT02355184) published in the CytoDyn Media Release
    • 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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