A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs

A Phase II Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs Among ART Stabilized HIV-1 Patients Who Undergo ART Interruption

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05056974

Enrollment

Registered

2021-09-27

Start date

2021-12-02

Completion date

2023-02-01

Last updated

2023-02-15

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 proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.

Interventions

BIOLOGICALUB-421

10 mg/kg, weekly UB-421 during the 8-week

DRUGchidamide

10 mg/dose, twice a week for 8 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history 2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older. 3. No breastfeeding or pregnancy for women. 4. Have been receiving ART for more than 3 years by screening visit 1 (SV1). 5. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception 6. Subjects must sign the informed consent before undergoing any study procedures.

Exclusion criteria

1. Subjects with active systemic infections, except for HIV-1 2. Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug. 3. Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis 4. Any alcohol or illicit drug use 5. Receipt of any other investigational study agent(s) within 90 days before SV2. 6. Currently on the treatment for diabetes.

Design outcomes

Primary

Measure	Time frame	Description
HIV cell-associated RNA levels	Post-treatment weeks up to 48 weeks	The change in HIV-1 Total DNA from baseline after study drug administration.

Secondary

Measure	Time frame	Description
HIV-1 Total DNA levels	Post-treatment weeks up to 48 weeks	The changes in HIV-1 Total DNA levels during the study

Countries

Taiwan

Outcome results

None listed

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