A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
| Registry | NCT04406727 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | United BioPharma (Industry) |
| Conditions | HIV-1 Infection |
| Interventions | UB-421, Antiretroviral (ARV) (Biological, other) |
| Dates | start 2023-12-01 (estimated), primary completion 2026-06-30 (estimated), completion 2026-06-30 (estimated), first posted 2020-05-28, last updated 2023-04-24 |
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All trials for HIV-1 Infection All trials of UB-421 All trials of Antiretroviral (ARV)
The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| UB-421 | Experimental | Biological: UB-421; Other: Antiretroviral (ARV) | 2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR). |
| Placebo | Active comparator | Other: Antiretroviral (ARV) | 2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR). |
Sex: All, ages: 20 Years to any
Inclusion Criteria: 1. HIV-1 seropositive 2. Have a history of at least 6 months on antiretroviral treatment 3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening Exclusion Criteria: 1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN) 2. Females who are pregnant 3. Any vaccination within 2 weeks prior to the Screening 4. Any prior exposure to UB-421