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

NCT04404049•UBP Greater China (Shanghai) Co., Ltd

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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.

Eligibility

Age

20 - 100 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

December 1, 2023

Primary Completion Date

June 30, 2024

Completion Date

June 30, 2025

Last Updated

May 18, 2022

Enrollment

ESTIMATED participants

Conditions

HIV-1-infection

Interventions

UB-421(25 mg/kg) Q2W

BIOLOGICAL

UB-421(25 mg/kg) Q4W

BIOLOGICAL

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HIV-1-infection

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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