The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV-1-infection

Intervention / Treatment
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* Biological: UB-421(25 mg/kg) Q2W
* Biological: UB-421(25 mg/kg) Q4W


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard ART<br>Subjects will receive standard ART for 48 weeks | |
| Experimental: UB-421(25mg/kg) Q2W add-on treatment<br>UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks | Biological: UB-421(25 mg/kg) Q2W<br>* Monoclonal antibody by IV infusion plus standard ART<br>|
| Experimental: UB-421(25mg/kg) Q4W add-on treatment<br>UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks | Biological: UB-421(25 mg/kg) Q4W<br>* Monoclonal antibody by IV infusion plus standard ART<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment related TEAEs | the incidence of Grade 3 drug-related treatment-emergent adverse events | 48Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of immune profiles | Change in Treg percentage in the peripheral blood | 16Weeks |