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

Phase 3

Withdrawn

• Conditions: HIV-1 Infection
• Interventions: Drug: current standard HAART treatment; Drug: UB-421

• Registration Number: NCT03149211
• Lead Sponsor: United BioPharma

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25
• Study Start: 2025-04-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	current standard HAART treatment	Subjects will receive current standard HAART treatment as the active control group.
Cohort 2	current standard HAART treatment	Subjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment.
Cohort 2	UB-421	Subjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment.

Primary Outcome Measures

Name	Time	Method
Number of participants without virologic failure	24 weeks

Secondary Outcome Measures

Name	Time	Method
Peak concentration of UB-421 in Cohort 2	30 weeks
Time to virologic failure	26 weeks
Number of participants with treatment-related adverse events	48 weeks
Trough concentration of UB-421 in Cohort 2	30 weeks

Trial Locations

Locations (1)

Beijing Youan Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China