HIV-1 Infection Clinical Trial
Official title:
A Phase III, Randomized, Open-label, Controlled Trial to Investigate the Efficacy and Safety of UB-421 Monotherapy as Substitution for Stable Antiretroviral Therapy in HIV-1 Infected Adults
The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption.
This is an open-label, Phase III study to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound while replace HAART in virally suppressed HIV-1 infected adults. In this study, approximately 375 subjects on stable HAART treatment will be randomized to receive either continuing HAART treatment alone (Cohort 1) or UB-421 as the monotherapy (Cohort 2) in 1:2 ratio. For Cohort 1, subjects will receive current standard HAART treatment as the active control group. For Cohort 2, UB-421 will be administered to enrolled subjects without HAART treatment in the Cohort 2 during the 26-week treatment period. After treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period. ;
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