An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study
CD02_EA
An Expanded Compassionate Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PRO140_CD02 Study
1 other identifier
expanded_access
N/A
1 country
1
Brief Summary
The primary objective is to provide continued access to PRO 140 to a subject who has completed participation in PRO140\_CD02.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedMarch 13, 2018
August 1, 2017
April 19, 2016
March 12, 2018
Conditions
Interventions
PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- CytoDyn, Inc.lead
- Amarex Clinical Researchcollaborator
Study Sites (1)
CD02 EA Investigational site
Orlando, Florida, 32803, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Edwin DeJesus, MD, FIDSA
Orlando Immunology Center
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2016
First Posted
May 3, 2016
Last Updated
March 13, 2018
Record last verified: 2017-08