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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04404049

Acronym

HIV-1

Enrollment

Registered

2020-05-27

Start date

2023-12-01

Completion date

2025-06-30

Last updated

2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

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.

Interventions

BIOLOGICALUB-421(25 mg/kg) Q2W

Monoclonal antibody by IV infusion plus standard ART

BIOLOGICALUB-421(25 mg/kg) Q4W

Monoclonal antibody by IV infusion plus standard ART

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
the change of immune profiles	16Weeks	Change in Treg percentage in the peripheral blood

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026