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

A Phase II, Open-label, Multiple-dose Trial to Investigate the Safety and Efficacy of UB-421 Monotherapy in Substitution for Stable Antiretroviral Therapy in HIV Infected Adults

The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression.

Study Overview

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

Detailed Description

This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 29 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV-1 sero-positive
• Aged 20 years or older
• Have received HAART treatment
• CD4+ T cell count ≧ 350 cells/mm3
• HIV-1 plasma RNA level remains below the limit of
• 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 documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before screening visit
• 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
• Any vaccination within 8 weeks prior to the first dose of study drug
• Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug
• Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug
• Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
• More than one change of HAART regimen because of virologic failure

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
Experimental: cohort 1; Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly	Drug: UB-421; The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).; Other Names: dB4C7 mAb
Experimental: cohort 2; Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly	Drug: UB-421; The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).; Other Names: dB4C7 mAb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	17 weeks for cohort 1, 25 weeks for cohort 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak concentration of UB-421	8 weeks for cohort 1, 15 weeks for cohort 2
Trough concentration of UB-421	8 weeks for cohort 1, 15 weeks for cohort 2

Collaborators and Investigators

• Sponsor: United BioPharma
• Collaborators: Kaohsiung Medical University Chung-Ho Memorial Hospital; Taipei Veterans General Hospital, Taiwan; Kaohsiung Veterans General Hospital.
• Investigators: Principal Investigator: Wing Wai Wong, M.D., Taiwan, Taipei Veterans General Hospital; Principal Investigator: Yen Hsu Chen, M.D. PhD., Kaohsiung Medical University Chung-Ho Memorial Hospital; Principal Investigator: Hung Chin Tsai, M.D. PhD., Taiwan, Kaohsiung Veterans General Hospital

Publications and helpful links

General Publications

• Wang CY, Wong WW, Tsai HC, Chen YH, Kuo BS, Lynn S, Blazkova J, Clarridge KE, Su HW, Lin CY, Tseng FC, Lai A, Yang FH, Lin CH, Tseng W, Lin HY, Finstad CL, Wong-Staal F, Hanson CV, Chun TW, Liao MJ. Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption. N Engl J Med. 2019 Apr 18;380(16):1535-1545. doi: 10.1056/NEJMoa1802264.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 15, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 29, 2017
• Last Verified: October 1, 2017

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-A202-HIV