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

NCT03149211 | Withdrawn Phase 3 DMC

• 1 other identifier: UBP-A304-HIV
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

• Number of participants without virologic failure

  24 weeks

Secondary Outcomes (4)

• Time to virologic failure

  26 weeks

• Number of participants with treatment-related adverse events

  48 weeks

• Peak concentration of UB-421 in Cohort 2

  30 weeks

• Trough concentration of UB-421 in Cohort 2

  30 weeks

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

Subjects will receive current standard HAART treatment as the active control group.

Drug: current standard HAART treatment

Cohort 2

EXPERIMENTAL

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.

Drug: UB-421; Drug: current standard HAART treatment

Interventions

UB-421 DRUG

Subjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks).

Also known as: dB4C7 mAb

Cohort 2

current standard HAART treatment DRUG

Subjects will receive current standard HAART treatment as the active control group.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United BioPharma: lead

Study Sites (1)

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Interventions

UB-421

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 11, 2017
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)