NCT04404049

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2023

Status
unknown

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

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
3.5 years until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 21, 2020

Last Update Submit

May 16, 2022

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

  • treatment related TEAEs

    the incidence of Grade 3 drug-related treatment-emergent adverse events

    48Weeks

Secondary Outcomes (1)

  • the change of immune profiles

    16Weeks

Study Arms (3)

Standard ART

NO INTERVENTION

Subjects will receive standard ART for 48 weeks

UB-421(25mg/kg) Q2W add-on treatment

EXPERIMENTAL

UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks

Biological: UB-421(25 mg/kg) Q2W

UB-421(25mg/kg) Q4W add-on treatment

EXPERIMENTAL

UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks

Biological: UB-421(25 mg/kg) Q4W

Interventions

UB-421(25 mg/kg) Q2WBIOLOGICAL

Monoclonal antibody by IV infusion plus standard ART

UB-421(25mg/kg) Q2W add-on treatment
UB-421(25 mg/kg) Q4WBIOLOGICAL

Monoclonal antibody by IV infusion plus standard ART

UB-421(25mg/kg) Q4W add-on treatment

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 sero-positive
  • Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
  • HIV-1 plasma RNA level below 50 RNA copies/mL.

You may not qualify if:

  • Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
  • Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
  • Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
  • History of anaphylaxis to other mAbs.
  • Any vaccination within 8 weeks prior to the first dose of assigned drug.
  • Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
  • Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

UB-421

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

December 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

May 18, 2022

Record last verified: 2022-05