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NCT02759042 Clinical Trial

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

HIV Clinical Trial

— CD02_EA  

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02759042
Other study ID # PRO140 CD02_EA
Secondary ID
Status No longer available
Phase N/A
First received April 19, 2016
Last updated March 12, 2018

Study information
Verified date August 2017
Source CytoDyn, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 55 Years to 56 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States CD02 EA Investigational site Orlando Florida

Sponsors (2)
Lead Sponsor Collaborator
CytoDyn, Inc. Amarex Clinical Research

Country where clinical trial is conducted

United States, 

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