<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/NCT02990858</url>
  </required_header>
  <id_info>
    <org_study_id>PRO 140 _CD02 Extension</org_study_id>
    <nct_id>NCT02990858</nct_id>
  </id_info>
  <brief_title>An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study</brief_title>
  <official_title>An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CytoDyn, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CytoDyn, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an extension study, to provide continued access to PRO 140 to subjects who complete&#xD;
      participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO&#xD;
      140 to form a viable regimen, in the opinion of the treating physician. The patient&#xD;
      population for this trial are treatment-experienced HIV infected patients with CCR5-tropic&#xD;
      virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of&#xD;
      treatment in the PRO140_CD02 study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 3, 2016</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period</measure>
    <time_frame>through study completion, an average of 4 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in CD4 cell count at the conclusion of treatment period</measure>
    <time_frame>through study completion, an average of 4 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergence of Dual/Mixed (D/M)- and CXCR4-tropic virus in patients who had exclusive CCR5- tropic virus at study entry.</measure>
    <time_frame>through study completion, an average of 4 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions</measure>
    <time_frame>through study completion, an average of 4 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of treatment-related adverse events resulting in study drug discontinuation</measure>
    <time_frame>through study completion, an average of 4 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale</measure>
    <time_frame>through study completion, an average of 4 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of treatment-emergent serious adverse events</measure>
    <time_frame>through study completion, an average of 4 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Hiv</condition>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>PRO 140</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRO 140 SC injections</intervention_name>
    <arm_group_label>PRO 140</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Potential subjects are required to meet all of the following criteria&#xD;
        for enrollment into the study.&#xD;
&#xD;
          1. Subjects who have completed 24 weeks of treatment in PRO 140_CD 02 study, and&#xD;
             Investigator believes subject requires continued access to PRO 140 in order to&#xD;
             continue deriving clinical benefit and maintain HIV-1 viral suppression&#xD;
&#xD;
          2. HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140_CD02 study&#xD;
&#xD;
          3. Both male and female patients and their partners of childbearing potential must agree&#xD;
             to use 2 medically accepted methods of contraception (e.g., barrier contraceptives&#xD;
             [male condom, female condom, or diaphragm with a spermicidal gel], hormonal&#xD;
             contraceptives [implants, injectables, combination oral contraceptives, transdermal&#xD;
             patches, or contraceptive rings], and intrauterine devices) during the course of the&#xD;
             study (excluding women who are not of childbearing potential and men who have been&#xD;
             sterilized).&#xD;
&#xD;
             Females of childbearing potential must have a negative urine pregnancy test prior to&#xD;
             receiving the first dose of study drug.&#xD;
&#xD;
          4. Willing and able to participate in all aspects of the study, including use of SC&#xD;
             medication, completion of subjective evaluations, attendance at scheduled clinic&#xD;
             visits, and compliance with all protocol requirements as evidenced by providing&#xD;
             written informed consent.&#xD;
&#xD;
        Exclusion Criteria: Potential subjects meeting any of the following criteria will be&#xD;
        excluded from enrollment.&#xD;
&#xD;
          1. Not currently enrolled in PRO 140_CD 02 study&#xD;
&#xD;
          2. Any active infection or malignancy requiring acute therapy (with the exception of&#xD;
             local cutaneous Kaposi's sarcoma)&#xD;
&#xD;
          3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant&#xD;
             during the study&#xD;
&#xD;
          4. Any other clinical condition that, in the Investigator's judgment, would potentially&#xD;
             compromise study compliance or the ability to evaluate safety measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02990858
org study id: PRO 140 _CD02 Extension
nct id: NCT02990858
lead sponsor: 
has dmc: Yes
This is an extension study, to provide continued access to PRO 140 to subjects who complete
      participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO
      140 to form a viable regimen, in the opinion of the treating physician. The patient
      population for this trial are treatment-experienced HIV infected patients with CCR5-tropic
      virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of
      treatment in the PRO140_CD02 study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period
time frame: through study completion, an average of 4 year
measure: Mean change in CD4 cell count at the conclusion of treatment period
time frame: through study completion, an average of 4 year
measure: Emergence of Dual/Mixed (D/M)- and CXCR4-tropic virus in patients who had exclusive CCR5- tropic virus at study entry.
time frame: through study completion, an average of 4 year
measure: Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions
time frame: through study completion, an average of 4 year
measure: Frequency of treatment-related adverse events resulting in study drug discontinuation
time frame: through study completion, an average of 4 year
measure: Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale
time frame: through study completion, an average of 4 year
measure: Frequency of treatment-emergent serious adverse events
time frame: through study completion, an average of 4 year
arm group label: PRO 140
arm group type: Experimental
intervention type: Drug
intervention name: PRO 140 SC injections
arm group label: PRO 140
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Leronlimab
sharing ipd: Undecided