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The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743376
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : May 13, 2022
Sponsor:
Collaborators:
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Taoyuan General Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
Information provided by (Responsible Party):
United BioPharma

Study Description
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Brief Summary:
This study evaluate the safety of UB-421 in combination with standard antiretroviral therapy (ART) and the efficacy of HIV reservoir reduction as compared with ART alone in ART stabilized HIV-1 patients

Condition or disease Intervention/treatment Phase
HIV-1 Infection Biological: UB-421(25 mg/kg) Q2W Biological: UB-421(25 mg/kg) Q4W Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The HIV Functional Cure Potential of UB-421: A Phase II, Randomized, Open-label, Controlled, 48 Week, Proof of Concept Study, to Evaluate the Safety of UB-421 in Combination With Standard Antiretroviral Therapy (ART) and the Efficacy of HIV Reservoir Reduction as Compared With ART Alone in ART Stabilized HIV-1 Patients
Actual Study Start Date : December 12, 2018
Actual Primary Completion Date : October 15, 2020
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard ART
Subjects will receive standard ART for 48 weeks
Experimental: UB-421(25mg/kg) Q2W add-on treatment
UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
 Biological: UB-421(25 mg/kg) Q2W
Monoclonal antibody by IV infusion plus standard ART
Experimental: UB-421(25mg/kg) Q4W add-on treatment
UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks
 Biological: UB-421(25 mg/kg) Q4W
Monoclonal antibody by IV infusion plus standard ART


Outcome Measures
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Primary Outcome Measures :
  1. treatment related TEAEs [ Time Frame: 48Weeks ]
    the incidence of Grade 3 drug-related treatment-emergent adverse events


Secondary Outcome Measures :
  1. the change of immune profiles [ Time Frame: 16Weeks ]
    Change in Treg percentage in the peripheral blood


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-1 sero-positive
  2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.
  3. HIV-1 plasma RNA level below 50 RNA copies/mL .

Exclusion Criteria:

  1. Subjects with active systemic infections, except for HIV-1, that the Investigator feels the infections may confound evaluation and treatment for HIV-1.
  2. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.
  3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.
  4. History of anaphylaxis to other mAbs.
  5. Any vaccination within 8 weeks prior to the first dose of assigned drug.
  6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior to the first dose of assigned drug.
  7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743376


Locations
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Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 201
Sponsors and Collaborators
United BioPharma
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Taoyuan General Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT03743376    
Other Study ID Numbers: UBP-A209-HIV
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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UB-421
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents