To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults

HIV-1 Infection Clinical Trial

Official title:

A Phase III, Randomized, Open-label, Controlled Trial to Investigate the Efficacy and Safety of UB-421 Monotherapy as Substitution for Stable Antiretroviral Therapy in HIV-1 Infected Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03149211
• Other study ID #: UBP-A304-HIV
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 1, 2025
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: United BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption.

Description:

This is an open-label, Phase III study to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound while replace HAART in virally suppressed HIV-1 infected adults. In this study, approximately 375 subjects on stable HAART treatment will be randomized to receive either continuing HAART treatment alone (Cohort 1) or UB-421 as the monotherapy (Cohort 2) in 1:2 ratio. For Cohort 1, subjects will receive current standard HAART treatment as the active control group. For Cohort 2, UB-421 will be administered to enrolled subjects without HAART treatment in the Cohort 2 during the 26-week treatment period. After treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• HIV-1 sero-positive
• Aged 20 years or older
• Were not breastfeeding for women
• Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
• Subjects agree on using birth control barrier (female or male condom) during the entire study period
• Subjects sign the informed consent before undergoing any study procedures

Exclusion Criteria:

• Any active infection except for HIV, and required immediate therapy
• Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
• Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
• Life expectancy less than 12 months
• Any alcohol or illicit drug used, according to the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• UB-421
Subjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks).
• current standard HAART treatment
Subjects will receive current standard HAART treatment as the active control group.

Locations

Country	Name	City	State
China	Beijing Youan Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
United BioPharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants without virologic failure		24 weeks
Secondary	Time to virologic failure		26 weeks
Secondary	Number of participants with treatment-related adverse events		48 weeks
Secondary	Peak concentration of UB-421 in Cohort 2		30 weeks
Secondary	Trough concentration of UB-421 in Cohort 2		30 weeks