<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/NCT04406727</url>
  </required_header>
  <id_info>
    <org_study_id>UBP-A308-HIV</org_study_id>
    <nct_id>NCT04406727</nct_id>
  </id_info>
  <brief_title>UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United BioPharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United BioPharma</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>
      The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421&#xD;
      Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA&#xD;
      viral load.&#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, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2026</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HIV-1 RNA viral load between 2 arms</measure>
    <time_frame>14 Days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>HIV-1 Infection</condition>
  <arm_group>
    <arm_group_label>UB-421</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2-arm Comparison Phase: UB-421(25 mg/kg, every 2 weeks) in combination with ARV&#xD;
Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2-arm Comparison Phase: Placebo in combination with ARV&#xD;
Single-arm Maintenance Phase: UB-421 plus optimized background regimen (OBR).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UB-421</intervention_name>
    <description>UB-421 in combination with their ARV</description>
    <arm_group_label>UB-421</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Antiretroviral (ARV)</intervention_name>
    <description>Antiretroviral (ARV)</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>UB-421</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. HIV-1 seropositive&#xD;
&#xD;
          2. Have a history of at least 6 months on antiretroviral treatment&#xD;
&#xD;
          3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks&#xD;
             before Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST &gt; 4 x&#xD;
             upper limit of normal (ULN)&#xD;
&#xD;
          2. Females who are pregnant&#xD;
&#xD;
          3. Any vaccination within 2 weeks prior to the Screening&#xD;
&#xD;
          4. Any prior exposure to UB-421&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Linda Shih</last_name>
    <phone>+886-3-668-4800</phone>
    <phone_ext>3204</phone_ext>
    <email>linda.shih@unitedbiopharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhonghao Shi</last_name>
    <phone>+886-3-668-4800</phone>
    <phone_ext>3201</phone_ext>
    <email>zhonghao.shi@unitedbiopharma.com</email>
  </overall_contact_backup>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Retroviral Agents</mesh_term>
    <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/NCT04406727
org study id: UBP-A308-HIV
nct id: NCT04406727
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in HIV-1 RNA viral load between 2 arms
time frame: 14 Days
arm group label: UB-421
arm group type: Experimental
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 group label: Placebo
arm group type: Active Comparator
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: UB-421
description: UB-421 in combination with their ARV
arm group label: UB-421
intervention type: Other
intervention name: Antiretroviral (ARV)
description: Antiretroviral (ARV)
arm group label: Placebo
arm group label: UB-421
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Linda Shih
phone: +886-3-668-4800
phone ext: 3204
email: linda.shih@unitedbiopharma.com
last name: Zhonghao Shi
phone: +886-3-668-4800
phone ext: 3201
email: zhonghao.shi@unitedbiopharma.com
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: HIV Infections
mesh term: Anti-Retroviral Agents
mesh term: UB-421