An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study (CD02_EA)

March 12, 2018 updated by: CytoDyn, Inc.

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

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • CD02 EA Investigational site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 56 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytoDyn, Inc.

Collaborators

Amarex Clinical Research

Investigators

  • Principal Investigator: Edwin DeJesus, MD, FIDSA, Orlando Immunology Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO140 CD02_EA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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