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

HIV-1-infection Clinical Trial

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

Clinical Trial 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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05271370
Study type Interventional
Source CytoDyn, Inc.
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date August 29, 2017
Completion date April 10, 2023
View Details
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