<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/NCT02257788</url>
  </required_header>
  <id_info>
    <org_study_id>1210001606</org_study_id>
    <secondary_id>5U01AI095085-03</secondary_id>
    <nct_id>NCT02257788</nct_id>
  </id_info>
  <brief_title>PRO 140 for Human Immunodeficiency Virus Infection</brief_title>
  <official_title>PRO 140 2103: A Phase 2a, Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drexel University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Drexel University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female&#xD;
      adult subjects infected with CCR5-tropic HIV-1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in&#xD;
      approximately 40 male and female adult subjects (n=10/treatment group) infected with&#xD;
      CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood&#xD;
      samples for drug concentrations, PD variables, and efficacy variables will be obtained over a&#xD;
      59-day period following initiation of dosing. Safety will be monitored throughout the course&#xD;
      of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unlikely to achieve targeted accrual&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Maximum change in viral load following initiation of different dosing regimens of PRO140</measure>
    <time_frame>59 days</time_frame>
    <description>Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Treatment Arm 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PRO 140: one SC dose, 350 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PRO 140: one SC loading dose, 700 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PRO 140: one SC loading dose, 700 mg (day 1), followed by one single SC dose 350 mg (day 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRO 140</intervention_name>
    <description>Humanized monoclonal antibody to CCR5</description>
    <arm_group_label>Treatment Arm 1</arm_group_label>
    <arm_group_label>Treatment Arm 2</arm_group_label>
    <arm_group_label>Treatment Arm 3</arm_group_label>
    <arm_group_label>Treatment Arm 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females, age ≥18 years&#xD;
&#xD;
          2. Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening&#xD;
             visit&#xD;
&#xD;
          3. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL&#xD;
&#xD;
          4. CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal&#xD;
             to 250 cells/mm3&#xD;
&#xD;
          5. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity&#xD;
             Trofile™ HIV Tropism Assay&#xD;
&#xD;
          6. Clinically normal resting 12-lead ECG at screening visit&#xD;
&#xD;
          7. Women of reproductive potential must have a negative serum pregnancy test at Late&#xD;
             Screening Visit. Within hours prior to receiving the first dose of study drug, women&#xD;
             of reproductive potential must have a negative urine pregnancy test. Male and female&#xD;
             subjects must agree not to participate in a conception process and agree to use one&#xD;
             barrier method of contraception plus one other highly reliable contraceptive method&#xD;
             from the early screening visit through three weeks after the last administered&#xD;
             subcutaneous dose of PRO 140.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced&#xD;
             Sensitivity Trofile™ HIV Tropism Assay&#xD;
&#xD;
          2. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant&#xD;
             during the study&#xD;
&#xD;
          3. Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A&#xD;
             or a new diagnosis of hepatitis B or C within 24 weeks of dosing)&#xD;
&#xD;
          4. Chronic hepatitis&#xD;
&#xD;
          5. Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including&#xD;
             PRO 140, experimental or approved&#xD;
&#xD;
          6. Any immunization or vaccination (including influenza vaccine) within 30 days prior to&#xD;
             administration of study drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey Jacobson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Drexel University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University (Stanford AIDS Clinical Trials Unit)</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver (Colorado ACTU)</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University College of Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston (Houston AIDS Research team (HART)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2017</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>Acquired Immunodeficiency Syndrome</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>Leronlimab</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/NCT02257788
org study id: 1210001606
secondary id: 5U01AI095085-03
nct id: NCT02257788
lead sponsor: 
collaborator: 
has dmc: Yes
PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female
      adult subjects infected with CCR5-tropic HIV-1.
Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in
      approximately 40 male and female adult subjects (n=10/treatment group) infected with
      CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood
      samples for drug concentrations, PD variables, and efficacy variables will be obtained over a
      59-day period following initiation of dosing. Safety will be monitored throughout the course
      of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum change in viral load following initiation of different dosing regimens of PRO140
time frame: 59 days
description: Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL
arm group label: Treatment Arm 1
arm group type: Active Comparator
description: PRO 140: one SC dose, 350 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
arm group label: Treatment Arm 2
arm group type: Active Comparator
description: PRO 140: one SC loading dose, 700 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
arm group label: Treatment Arm 3
arm group type: Active Comparator
description: PRO 140: one SC loading dose, 700 mg (day 1), followed by one single SC dose 350 mg (day 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
arm group label: Treatment Arm 4
arm group type: Active Comparator
description: PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
intervention type: Biological
intervention name: PRO 140
description: Humanized monoclonal antibody to CCR5
arm group label: Treatment Arm 1
arm group label: Treatment Arm 2
arm group label: Treatment Arm 3
arm group label: Treatment Arm 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey Jacobson, MD
role: Study Chair
affiliation: Drexel University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Leronlimab