A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs

A Phase II Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs Among ART Stabilized HIV-1 Patients Who Undergo ART Interruption

This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Biological: UB-421; Drug: chidamide

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, Taiwan
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
3. No breastfeeding or pregnancy for women.
4. Have been receiving ART for more than 3 years by screening visit 1 (SV1).
5. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
6. Subjects must sign the informed consent before undergoing any study procedures.

Exclusion Criteria:

1. Subjects with active systemic infections, except for HIV-1
2. Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
3. Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
4. Any alcohol or illicit drug use
5. Receipt of any other investigational study agent(s) within 90 days before SV2.
6. Currently on the treatment for diabetes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UB-421 + chidamide; UB-421 + chidamide combination therapy	Biological: UB-421; 10 mg/kg, weekly UB-421 during the 8-week; Drug: chidamide; 10 mg/dose, twice a week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV cell-associated RNA levels	The change in HIV-1 Total DNA from baseline after study drug administration.	Post-treatment weeks up to 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV-1 Total DNA levels	The changes in HIV-1 Total DNA levels during the study	Post-treatment weeks up to 48 weeks

Collaborators and Investigators

• Sponsor: United BioPharma

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents; UB-421
• Other Study ID Numbers: UBP-A232-HIV

Drug and device information, study documents

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