The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (HIV-1)
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ClinicalTrials.gov Identifier: NCT04404049 |
Recruitment Status :
Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : April 28, 2021
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Sponsor:
UBP Greater China (Shanghai) Co., Ltd
Information provided by (Responsible Party):
UBP Greater China (Shanghai) Co., Ltd
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Brief 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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-1-infection | Biological: UB-421(25 mg/kg) Q2W Biological: UB-421(25 mg/kg) Q4W | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 39 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Estimated Study Start Date : | December 1, 2021 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2024 |
Arm | Intervention/treatment |
---|---|
No Intervention: Standard ART
Subjects will receive standard ART for 48 weeks
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Experimental: UB-421(25mg/kg) Q2W add-on treatment
UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
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Biological: UB-421(25 mg/kg) Q2W
Monoclonal antibody by IV infusion plus standard ART |
Experimental: UB-421(25mg/kg) Q4W add-on treatment
UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks
|
Biological: UB-421(25 mg/kg) Q4W
Monoclonal antibody by IV infusion plus standard ART |
Primary Outcome Measures :
- treatment related TEAEs [ Time Frame: 48Weeks ]the incidence of Grade 3 drug-related treatment-emergent adverse events
Secondary Outcome Measures :
- the change of immune profiles [ Time Frame: 16Weeks ]Change in Treg percentage in the peripheral blood
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Ages Eligible for Study: | 20 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-1 sero-positive
- Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
- HIV-1 plasma RNA level below 50 RNA copies/mL.
Exclusion Criteria:
- Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
- Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
- Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
- History of anaphylaxis to other mAbs.
- Any vaccination within 8 weeks prior to the first dose of assigned drug.
- Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
No Contacts or Locations Provided
Responsible Party: | UBP Greater China (Shanghai) Co., Ltd |
ClinicalTrials.gov Identifier: | NCT04404049 |
Other Study ID Numbers: |
UBP-A218-HIV |
First Posted: | May 27, 2020 Key Record Dates |
Last Update Posted: | April 28, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
UB-421 Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |