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

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ClinicalTrials.gov Identifier: NCT04404049
Recruitment Status : Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
UBP Greater China (Shanghai) Co., Ltd

Study Description
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Brief Summary:
This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be conducted at multiple study centers, designated AIDS hospitals in China.

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)
Estimated Enrollment : 39 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
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2024

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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No Contacts or Locations Provided
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: UBP Greater China (Shanghai) Co., Ltd
ClinicalTrials.gov Identifier: NCT04404049    
Other Study ID Numbers: UBP-A218-HIV
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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