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The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

NCT04404049 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-05-18

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

UB-421(25 mg/kg) Q2W

Monoclonal antibody by IV infusion plus standard ART

BIOLOGICAL

UB-421(25 mg/kg) Q4W

Monoclonal antibody by IV infusion plus standard ART

Sponsors & Collaborators

  • UBP Greater China (Shanghai) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-06-30
Completion
2025-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04404049 on ClinicalTrials.gov