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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
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03743376
Enrollment
31
Registered
2018-11-16
Start date
2018-12-12
Completion date
2021-12-31
Last updated
2022-05-13

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 study 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

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

Sponsors

National Taiwan University Hospital
CollaboratorOTHER
Taipei Veterans General Hospital, Taiwan
CollaboratorOTHER_GOV
Taoyuan General Hospital
CollaboratorOTHER_GOV
Kaohsiung Medical University Chung-Ho Memorial Hospital
CollaboratorOTHER
Kaohsiung Veterans General Hospital.
CollaboratorOTHER
United BioPharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No

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

MeasureTime frameDescription
treatment related TEAEs48Weeksthe incidence of Grade 3 drug-related treatment-emergent adverse events

Secondary

MeasureTime frameDescription
the change of immune profiles16WeeksChange in Treg percentage in the peripheral blood

Countries

Taiwan

Outcome results

None listed

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