At a glance
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A Phase 2b/3, Multicenter Study to Assess the Treatment Strategy of Using PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects With CCR5-tropic HIV-1 Infection
In Brief
A Phase 3 clinical trial evaluating PRO 140 (350 mg), PRO 140 (525 mg), and 1 other intervention for HIV. Completed, enrolled 562 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
PRO 140 350 mg (175 mg/mL) SC injection per week
PRO 140 525 mg (175 mg/mL) SC injection per week
PRO 140 700 mg (175 mg/mL) SC injection per week