Overview

An Extension of Protocol PRO 140_CD01 TS Study

Status:
Active, not recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who were stable on combination antiretroviral therapy and completed 12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing virologic failure. Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks. Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of existing retroviral regimen and PRO 140 at the end of the treatment extension phase in subjects who do not experience virologic failure.
Phase:
Phase 2
Details
Lead Sponsor:
CytoDyn, Inc.
Treatments:
HIV Antibodies
Leronlimab
PRO-140 monoclonal antibody