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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: Biological: UB-421(25 mg/kg) Q2W; Biological: UB-421(25 mg/kg) Q4W

• Study Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. HIV-1 sero-positive
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
3. HIV-1 plasma RNA level below 50 RNA copies/mL.

Exclusion Criteria:

1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
2. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
4. History of anaphylaxis to other mAbs.
5. Any vaccination within 8 weeks prior to the first dose of assigned drug.
6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard ART; Subjects will receive standard ART for 48 weeks
Experimental: UB-421(25mg/kg) Q2W add-on treatment; UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UBP Greater China (Shanghai) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents; UB-421
• Other Study ID Numbers: UBP-A218-HIV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No