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The study will not be submitted to authority for IND application.
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This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 (Standard ART) | Active Comparator | Standard ART |
|
| Arm 2 (ART plus UB-421) | Experimental | ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-421 | Biological | Monoclonal antibody by IV infusion plus standard ART |
| |
| Measure | Description | Time Frame |
|---|---|---|
| treatment related TEAEs | the incidence of Grade 3 drug-related treatment-emergent adverse events | 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Antiretroviral Therapy (ART) |
| Other |
Standard ART |
|
| ID | Term |
|---|---|
| C000630912 | UB-421 |
| D023241 | Antiretroviral Therapy, Highly Active |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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