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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UB-421 monotherapy | Experimental | Subjects will receive 10 mg/kg UB-421 weekly infusion for 8 weeks. |
|
| UB-421 + chidamide combination therapy | Experimental | Subjects will receive 10 mg/kg UB-421 weekly infusion and 10 mg chidamide twice a week administration for 8weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-421 | Biological | 10mg/kg weekly intravenous infusion to substitute for for antiretroviral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 Total DNA levels | The change in HIV-1 Total DNA from baseline after the study drug administration. | Post-treatment weeks up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 Total DNA levels | The changes in HIV-1 Total DNA levels during the study | 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) |
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Inclusion Criteria:
Subjects are eligible to be included in the study only if ALL of the following criteria apply:
Exclusion Criteria:
Subjects meeting ANY of the following criteria will be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Shih, MSc | Contact | +886 36684800 | 3851 | linda.shih@unitedbiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| undergoing undergoing, MD | undergoing | Study Chair |
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| ID | Term |
|---|---|
| C000630912 | UB-421 |
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| UB-421+chidamide | Other | 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. |
|
| 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. | 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. | Post-treatment weeks up to 48 weeks |