the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04041362

Enrollment

Registered

2019-08-01

Start date

2020-04-30

Completion date

2021-03-31

Last updated

2020-02-21

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

Conditions

HIV-1 Infection

Keywords

HIV, UB-421

Brief summary

This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.

Interventions

BIOLOGICALUB-421

Monoclonal antibody by IV infusion plus standard ART

OTHERAntiretroviral Therapy (ART)

Standard ART

Study design

Allocation

NON_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 seropositive 2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg. 3. have been receiving antiretroviral therapy (ART) for more than 2 years

Exclusion criteria

1. Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment. 2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study. 3. History of anaphylaxis to monoclonal antibodies. 4. Any vaccination within 8 weeks prior to the first dose of UB-421.

Design outcomes

Primary

Measure	Time frame	Description
treatment related TEAEs	16 Weeks	the incidence of Grade 3 drug-related treatment-emergent adverse events

Outcome results

None listed

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