NCT05056974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 15, 2023

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

August 18, 2021

Last Update Submit

February 13, 2023

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

  • HIV cell-associated RNA levels

    The change in HIV-1 Total DNA from baseline after study drug administration.

    Post-treatment weeks up to 48 weeks

Secondary Outcomes (1)

  • HIV-1 Total DNA levels

    Post-treatment weeks up to 48 weeks

Study Arms (1)

UB-421 + chidamide

EXPERIMENTAL

UB-421 + chidamide combination therapy

Biological: UB-421Drug: chidamide

Interventions

UB-421BIOLOGICAL

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

UB-421 + chidamide
chidamideDRUG

10 mg/dose, twice a week for 8 weeks

UB-421 + chidamide

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan, Taiwan

Location

MeSH Terms

Interventions

UB-421N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

September 27, 2021

Study Start

December 2, 2021

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 15, 2023

Record last verified: 2022-08

Locations

TW(1)