<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04404049</url>
  </required_header>
  <id_info>
    <org_study_id>UBP-A218-HIV</org_study_id>
    <nct_id>NCT04404049</nct_id>
  </id_info>
  <brief_title>The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients</brief_title>
  <acronym>HIV-1</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UBP Greater China (Shanghai) Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UBP Greater China (Shanghai) Co., Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess&#xD;
      the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard&#xD;
      ART in ART-treated HIV-1 subjects with stably suppressed HIV-1 plasma VL. The study will be&#xD;
      conducted at multiple study centers, designated AIDS hospitals in China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2023</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>treatment related TEAEs</measure>
    <time_frame>48Weeks</time_frame>
    <description>the incidence of Grade 3 drug-related treatment-emergent adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change of immune profiles</measure>
    <time_frame>16Weeks</time_frame>
    <description>Change in Treg percentage in the peripheral blood</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">39</enrollment>
  <condition>HIV-1-infection</condition>
  <arm_group>
    <arm_group_label>Standard ART</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will receive standard ART for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-421(25mg/kg) Q2W add-on treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-421(25mg/kg) Q4W add-on treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UB-421(25 mg/kg) Q2W</intervention_name>
    <description>Monoclonal antibody by IV infusion plus standard ART</description>
    <arm_group_label>UB-421(25mg/kg) Q2W add-on treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UB-421(25 mg/kg) Q4W</intervention_name>
    <description>Monoclonal antibody by IV infusion plus standard ART</description>
    <arm_group_label>UB-421(25mg/kg) Q4W add-on treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HIV-1 sero-positive&#xD;
&#xD;
          2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg.&#xD;
&#xD;
          3. HIV-1 plasma RNA level below 50 RNA copies/mL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with active systemic infections, except for HIV-1, that the Investigator&#xD;
             feels the infections may confound evaluation and treatment for HIV-1.&#xD;
&#xD;
          2. Current active hepatitis B carriers, ie, hepatitis B surface antigen positive.&#xD;
&#xD;
          3. Current active hepatitis C carriers, ie, hepatitis C virus (HCV) antibody positive.&#xD;
&#xD;
          4. History of anaphylaxis to other mAbs.&#xD;
&#xD;
          5. Any vaccination within 8 weeks prior to the first dose of assigned drug.&#xD;
&#xD;
          6. Use of immunomodulators, HIV vaccine, or systemic chemotherapy within 180 days prior&#xD;
             to the first dose of assigned drug.&#xD;
&#xD;
          7. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant&#xD;
             during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>UB-421</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04404049
org study id: UBP-A218-HIV
nct id: NCT04404049
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: treatment related TEAEs
time frame: 48Weeks
description: the incidence of Grade 3 drug-related treatment-emergent adverse events
measure: the change of immune profiles
time frame: 16Weeks
description: Change in Treg percentage in the peripheral blood
arm group label: Standard ART
arm group type: No Intervention
description: Subjects will receive standard ART for 48 weeks
arm group label: UB-421(25mg/kg) Q2W add-on treatment
arm group type: Experimental
description: UB-421(25 mg/kg) Q2W plus standard ART for 48 weeks
arm group label: UB-421(25mg/kg) Q4W add-on treatment
arm group type: Experimental
description: UB-421(25 mg/kg) Q4W plus standard ART for 48 weeks
intervention type: Biological
intervention name: UB-421(25 mg/kg) Q2W
description: Monoclonal antibody by IV infusion plus standard ART
arm group label: UB-421(25mg/kg) Q2W add-on treatment
intervention type: Biological
intervention name: UB-421(25 mg/kg) Q4W
description: Monoclonal antibody by IV infusion plus standard ART
arm group label: UB-421(25mg/kg) Q4W add-on treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: UB-421