drugset / Trial / NCT02990858

An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study

NCT02990858 ↗

Phase 2/3 Terminated 43 enrolled CytoDyn, Inc.
NaSingle-groupOpen-labelTreatment

Summary

PRO 140\_CD02 Extension study seeks to evaluate the long-term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized Background Therapy (OBT) in patients infected with Human Immunodeficiency virus (HIV-1).

Timeline

Start
2016-11-03
Primary completion
2022-06
Completion
2022-07-10

Outcome

Outcome not reported

Stopped (Enrollment): “FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Leronlimab Monoclonal antibody 350 mg Other
Subject Leronlimab Monoclonal antibody 700 mg Other