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

CytoDyn

Status

Conditions: HIV

Treatments: Drug: PRO 140

Study type: Expanded Access

Funder types: Other; Industry

Identifiers

NCT02759042

PRO140 CD02_EA

Details and patient eligibility

About

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

Full 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.

Sex: Male

Ages: 55 to 56 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.