At a glance
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A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection
In Brief
A Phase 2 clinical trial evaluating PRO 140 and Historical data for HIV and Human Immunodeficiency Virus. Completed, enrolled 43 participants across 1 site.
Detailed Summary
This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy. Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.
Study Details
Timeline
Interventions
CCR5 Antagonist
Historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days).