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

HIV-1-infection Clinical Trial

— HIV-1  

Official title:

The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04404049
• Other study ID #: UBP-A218-HIV
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2022
• Source: UBP Greater China (Shanghai) Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Biological:
• UB-421(25 mg/kg) Q2W
Monoclonal antibody by IV infusion plus standard ART
• UB-421(25 mg/kg) Q4W
Monoclonal antibody by IV infusion plus standard ART

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UBP Greater China (Shanghai) Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment related TEAEs	the incidence of Grade 3 drug-related treatment-emergent adverse events	48Weeks
Secondary	the change of immune profiles	Change in Treg percentage in the peripheral blood	16Weeks