Trials / Unknown
UnknownNCT04404049
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- UBP Greater China (Shanghai) Co., Ltd · Industry
- Sex
- All
- Age
- 20 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UB-421(25 mg/kg) Q2W | Monoclonal antibody by IV infusion plus standard ART |
| BIOLOGICAL | UB-421(25 mg/kg) Q4W | Monoclonal antibody by IV infusion plus standard ART |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2024-06-30
- Completion
- 2025-06-30
- First posted
- 2020-05-27
- Last updated
- 2022-05-18
Source: ClinicalTrials.gov record NCT04404049. Inclusion in this directory is not an endorsement.