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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Subjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks).
Subjects will receive current standard HAART treatment as the active control group.
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Number of participants without virologic failure
Time frame: 24 weeks
Time to virologic failure
Time frame: 26 weeks
Number of participants with treatment-related adverse events
Time frame: 48 weeks
Peak concentration of UB-421 in Cohort 2
Time frame: 30 weeks
Trough concentration of UB-421 in Cohort 2
Time frame: 30 weeks
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