An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study

Overview

The primary objective is to provide continued access to PRO 140 to a subject who has completed participation in PRO140_CD02.

Full Title of Study: “An Expanded Compassionate Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PRO140_CD02 Study”

Study Type

  • Study Type: Expanded Access

Detailed Description

This is an open label, single center study designed to provide continued access to PRO 140 to a subject who have completed participation in PRO140_CD02 and continue to receive clinical benefit. The subject will receive weekly PRO 140 SC injection along with oral ART regimen during the Treatment Phase. The study treatment (PRO 140 SC injections) will be administered by a qualified medical professional or self-administered by the subject.

Interventions

  • Drug: PRO 140
    • PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.

Participating in This Clinical Trial

This study will recruit one treatment-experienced, HIV-1 infected patient with CCR5-tropic virus, who has participated in PRO 140_CD02 clinical trial and is continuing to derive clinical benefit from PRO 140 treatment.

Gender Eligibility: Male

Minimum Age: 55 Years

Maximum Age: 56 Years

Investigator Details

  • Lead Sponsor
    • CytoDyn, Inc.
  • Collaborator
    • Amarex Clinical Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Edwin DeJesus, MD, FIDSA, Principal Investigator, Orlando Immunology Center

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