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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Interventions

  • Biological: UB-421
    • Monoclonal antibody by IV infusion plus standard ART
  • Other: Antiretroviral Therapy (ART)
    • Standard ART

Arms, Groups and Cohorts

  • Active Comparator: Arm1 (Standard 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

Clinical Trial Outcome Measures

Primary Measures

  • treatment related TEAEs
    • Time Frame: 16 Weeks
    • the incidence of Grade 3 drug-related treatment-emergent adverse events

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • United BioPharma
  • Provider of Information About this Clinical Study
    • Sponsor

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