* To assess the impact of UB-421 and chidamide in changing HIV-1 viral reservoir profile among HIV-1 suppressed patients who undergo short-term ART interruption. * To evaluate the safety and tolerability of UB-421 combined with chidamide among HIV-1 suppressed patients who undergo short-term ART interruption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
10mg/kg weekly intravenous infusion to substitute for for antiretroviral therapy
10 mg/kg UB-421 weekly intravenous infusion to substitute for antiretroviral therapy, and combined with oral 10 mg chidamide twice a week for 8 weeks. Chidamide taken on the one day and three days after the administration of UB-421.
HIV-1 Total DNA levels
The change in HIV-1 Total DNA from baseline after the study drug administration.
Time frame: Post-treatment weeks up to 48 weeks
HIV-1 Total DNA levels
The changes in HIV-1 Total DNA levels during the study
Time frame: Post-treatment weeks up to 48 weeks
Treatment related TEAE
The incidence of Grade 3 or higher grade drug-related treatment-emergent adverse events (TEAE)
Time frame: through study completion, an average of 0.5 year
Viral suppression
Descriptive analysis of loss of viral suppression (HIV-1 VL\> 50 copies/ml) during the study period.
Time frame: Post-treatment weeks up to 48 weeks
The number of adverse subjects
The number of adverse subjects leading to discontinuation of UB 421 or Chidamide.
Time frame: Post-treatment weeks up to 48 weeks
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