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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

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ClinicalTrials.gov Identifier: NCT04041362
Recruitment Status : Withdrawn (The study will not be submitted to authority for IND application.)
First Posted : August 1, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
United BioPharma

Tracking Information
First Submitted Date  ICMJE July 31, 2019
First Posted Date  ICMJE August 1, 2019
Last Update Posted Date February 21, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2019)
treatment related TEAEs [ Time Frame: 16 Weeks ]
the incidence of Grade 3 drug-related treatment-emergent adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Biological: UB-421
    Monoclonal antibody by IV infusion plus standard ART
  • Other: Antiretroviral Therapy (ART)
    Standard ART
Study Arms  ICMJE
  • Active Comparator: Arm1 (Standard ART)
    Standard ART
    Intervention: Other: Antiretroviral Therapy (ART)
  • Experimental: Arm 2 (ART plus UB-421)
    ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks
    Interventions:
    • Biological: UB-421
    • Other: Antiretroviral Therapy (ART)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2019)
14
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04041362
Other Study ID Numbers  ICMJE UBP-A213-HIV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party United BioPharma
Study Sponsor  ICMJE United BioPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account United BioPharma
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP