NCT02990858

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140\_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with C-C Chemokine Receptor Type 5 (CCR5)-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140\_CD02 or CD02\_OpenLabel study.

Conditions

• Human Immunodeficiency Virus (HIV)

Interventions

Type	Name	Description
DRUG	PRO 140	PRO 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5). Participants received 350 or 700 mg weekly injections of PRO 140.

Timeline

• Start date: 2016-11-03
• Primary completion: 2022-06-01
• Completion: 2022-07-10
• First posted: 2016-12-13
• Last updated: 2025-11-12
• Results posted: 2025-11-12

Regulatory

• FDA-regulated drug study