Overview

Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection

Status:
Active, not recruiting

Trial end date:
2021-12-01

Target enrollment:

Participant gender:

Summary

This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry. Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

CytoDyn, Inc.

Treatments:

HIV Antibodies
Leronlimab
PRO-140 monoclonal antibody