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UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

Primary Purpose

HIV-1 Infection

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
UB-421
Antiretroviral (ARV)
Sponsored by
United BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. HIV-1 seropositive
  2. Have a history of at least 6 months on antiretroviral treatment
  3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening

Exclusion Criteria:

  1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)
  2. Females who are pregnant
  3. Any vaccination within 2 weeks prior to the Screening
  4. Any prior exposure to UB-421

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    UB-421

    Placebo

    Arm Description

    2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

    2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).

    Outcomes

    Primary Outcome Measures

    Change in HIV-1 RNA viral load between 2 arms

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2020
    Last Updated
    April 21, 2023
    Sponsor
    United BioPharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04406727
    Brief Title
    UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
    Official Title
    A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2026 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    United BioPharma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV-1 Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    UB-421
    Arm Type
    Experimental
    Arm Description
    2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).
    Arm Title
    Placebo
    Arm Type
    Active Comparator
    Arm Description
    2-arm Comparison Phase: Placebo in combination with ARV Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).
    Intervention Type
    Biological
    Intervention Name(s)
    UB-421
    Intervention Description
    UB-421 in combination with their ARV
    Intervention Type
    Other
    Intervention Name(s)
    Antiretroviral (ARV)
    Intervention Description
    Antiretroviral (ARV)
    Primary Outcome Measure Information:
    Title
    Change in HIV-1 RNA viral load between 2 arms
    Time Frame
    14 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV-1 seropositive Have a history of at least 6 months on antiretroviral treatment Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening Exclusion Criteria: Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN) Females who are pregnant Any vaccination within 2 weeks prior to the Screening Any prior exposure to UB-421
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Linda Shih
    Phone
    +886-3-668-4800
    Ext
    3204
    Email
    linda.shih@unitedbiopharma.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhonghao Shi
    Phone
    +886-3-668-4800
    Ext
    3201
    Email
    zhonghao.shi@unitedbiopharma.com

    12. IPD Sharing Statement

    Learn more about this trial

    UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

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