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

Phase 2

Not yet recruiting

• Conditions: HIV-1-infection
• Interventions: Biological: UB-421(25 mg/kg) Q2W; Biological: UB-421(25 mg/kg) Q4W

• Registration Number: NCT04404049
• Lead Sponsor: UBP Greater China (Shanghai) Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18
• Study Start: 2023-12-01
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UB-421(25mg/kg) Q2W add-on treatment	UB-421(25 mg/kg) Q2W	UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
UB-421(25mg/kg) Q4W add-on treatment	UB-421(25 mg/kg) Q4W	UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks

Primary Outcome Measures

Name	Time	Method
treatment related TEAEs	48Weeks	the incidence of Grade 3 drug-related treatment-emergent adverse events

Secondary Outcome Measures

Name	Time	Method
the change of immune profiles	16Weeks	Change in Treg percentage in the peripheral blood