NCT05271370

An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC (subcutaneous) monotherapy to maintain viral suppression after initial 48 weeks in virologically suppressed subjects. Consenting subjects will continue weekly PRO 140 350mg, 525mg, or 700mg monotherapy during the Treatment Extension Phase with the one-week overlap of existing retroviral regimen and PRO 140 350mg, 525mg, or 700 mg at the end of the treatment in subjects who do not experience virologic failure.

Detailed description

The objective is to assess the long-term safety of using PRO 140 350mg, 525mg, or 700mg SC as single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	PRO 140 350	Pro140 SC injection 350 mg
DRUG	PRO 140 525	525 mg
DRUG	PRO 140 700	700 mg

Timeline

• Start date: 2017-08-29
• Primary completion: 2022-06-20
• Completion: 2022-07-10
• First posted: 2022-03-09
• Last updated: 2025-10-30
• Results posted: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study