the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.

Study Overview

• Status: Withdrawn
• Conditions: HIV-1 Infection
• Intervention / Treatment: Other: Antiretroviral Therapy (ART); Biological: UB-421

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. HIV-1 seropositive
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
3. have been receiving antiretroviral therapy (ART) for more than 2 years

Exclusion Criteria:

1. Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment.
2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study.
3. History of anaphylaxis to monoclonal antibodies.
4. Any vaccination within 8 weeks prior to the first dose of UB-421.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm1 (Standard ART); Standard ART	Other: Antiretroviral Therapy (ART); Standard ART
Experimental: Arm 2 (ART plus UB-421); ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks	Other: Antiretroviral Therapy (ART); Standard ART; Biological: UB-421; Monoclonal antibody by IV infusion plus standard ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment related TEAEs	the incidence of Grade 3 drug-related treatment-emergent adverse events	16 Weeks

Collaborators and Investigators

• Sponsor: United BioPharma

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: HIV; UB-421
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents; UB-421
• Other Study ID Numbers: UBP-A213-HIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No