<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/NCT02990325</url>
  </required_header>
  <id_info>
    <org_study_id>ABX464-005</org_study_id>
    <nct_id>NCT02990325</nct_id>
  </id_info>
  <brief_title>A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults</brief_title>
  <official_title>An Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX464 in HIV-1 Seronegative and Seropositive Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abivax S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abivax S.A.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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 the ABX464-005 study is to characterize the systemic and mucosal immunological&#xD;
      sequelae associated with exposure to ABX464 and to explore selected immunological endpoints,&#xD;
      compartmental pharmacokinetics, and pharmacodynamics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological&#xD;
      sequelae associated with exposure to ABX464 and to explore selected immunological endpoints,&#xD;
      compartmental pharmacokinetics, and pharmacodynamics. The site will screen and enroll 12&#xD;
      HIV-infected subjects who will receive 150 mg ABX464 orally once daily for 28 days (Cohort&#xD;
      1). Following completion of this cohort a further 24 subjects will be enrolled: 12&#xD;
      HIV-uninfected subjects will receive 50 mg ABX464 orally once daily for 28 days (Cohort 2)&#xD;
      and 12 HIV-infected subjects (Cohort 3) who will 50 mg ABX464 orally once daily for 84 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Actual">October 21, 2019</completion_date>
  <primary_completion_date type="Actual">December 27, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) of ABX464 in Sera</measure>
    <time_frame>Day 1, Day 28 and Day 84</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of ABX464 in Sera</measure>
    <time_frame>Day 1, Day 28 and day 84</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera</measure>
    <time_frame>Day 1, Day 28 and Day 84</time_frame>
    <description>Pharmacokinetics parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera</measure>
    <time_frame>Day 1, Day 28 and Day 84</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)</measure>
    <time_frame>Day 1, Day 28 and Day 84</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)</measure>
    <time_frame>Day 1, Day 28 and Day 84</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)</measure>
    <time_frame>Day 1, Day 28 and Day 84</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)</measure>
    <time_frame>Day 1, Day 28 and Day 84</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)</measure>
    <time_frame>Day 1, Day 28, Day 56, Day 84 and Day 112</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)</measure>
    <time_frame>Day 1, Day 28, Day 56, Day 84 and Day 112</time_frame>
    <description>Pharmacokinetic parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)</measure>
    <time_frame>Day 28, Day 56, Day 84 and Day 112</time_frame>
    <description>Viral Load Assessments (HIV-1 RNA copies/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4+ Counts (Cell/mm^3)</measure>
    <time_frame>Day 28, Day 35, Day 56, Day 84, Day 91 and Day 112</time_frame>
    <description>T-cell determinations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)</measure>
    <time_frame>Day 28, Day 56, Day 84 and Day 112</time_frame>
    <description>HIV reservoir cells (CD4+)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>HIV Infections</condition>
  <condition>Health Volunteers</condition>
  <arm_group>
    <arm_group_label>ABX464 150mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABX464 50mg for 28 days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABX464, 50mg per Capsule One Capsule per day for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABX464 50mg for 84 days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABX464, 50mg per Capsule One Capsule per day for 84 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX464 150mg</intervention_name>
    <description>ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
    <arm_group_label>ABX464 150mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX464 50mg</intervention_name>
    <description>ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
    <arm_group_label>ABX464 50mg for 28 days</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX464 50mg</intervention_name>
    <description>ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
    <arm_group_label>ABX464 50mg for 84 days</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Males aged 18-65 years;&#xD;
&#xD;
          -  Subjects with adequate hematological and biochemical laboratory parameters&#xD;
&#xD;
          -  Subjects should be able and willing to comply with study visits and procedures as per&#xD;
             protocol;&#xD;
&#xD;
          -  Subjects should understand, sign and date the written voluntary informed consent form&#xD;
             at the screening visit prior to any protocol-specific procedures being performed;&#xD;
&#xD;
          -  Subjects must agree to use in addition to the condom, a second highly effective method&#xD;
             (one for the subject and one for the partner) of contraception (defined as per the&#xD;
             Clinical Trials Facilitation and Coordination Group (CTFG) Guidance).&#xD;
&#xD;
        For HIV positive Subjects&#xD;
&#xD;
          -  Subjects with a positive HIV-1 serology at any time before the study entry.&#xD;
&#xD;
          -  Subjects treated for at least 12 months prior to screening with Dolutegravir or&#xD;
             Raltegravir combined with either Tenofovir + Emtricitabine (TDF/FTC) or Abacavir +&#xD;
             Lamivudine (ABC/3TC);&#xD;
&#xD;
          -  Subjects with HIV plasma viral load ≤ 50 copies/mL during the 6 months prior to&#xD;
             screening with a maximum of 2 blips ≤ 1000 copies during this period;&#xD;
&#xD;
          -  Subjects' HIV-1 plasma viral load to be ≤ 100,000 copies/mL at any time beyond 6&#xD;
             months after the estimated date of primary infection;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergic disease, anaphylaxis or reactions likely to be triggered or&#xD;
             exacerbated by any component of investigational products;&#xD;
&#xD;
          -  Acute or chronic infectious disease other than HIV infection (include but not limited&#xD;
             to viral hepatitis such as hepatitis B, hepatitis C, active tuberculosis, active&#xD;
             syphilis [i.e. currently treated].&#xD;
&#xD;
          -  Acute, chronic or history of clinically relevant pulmonary, cardiovascular,&#xD;
             gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy,&#xD;
             neuropathy or unstable Central Nervous System (CNS) pathology, angina or cardiac&#xD;
             arrhythmias, or any other clinically significant medical problems as determined by&#xD;
             physical examination and/or laboratory screening tests and/or medical history;&#xD;
&#xD;
          -  Severe hepatic impairment;&#xD;
&#xD;
          -  Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV&#xD;
             infection;&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul GINESTE, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abivax S.A.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Catalogna</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 7, 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>
  <results_first_submitted>June 1, 2022</results_first_submitted>
  <results_first_submitted_qc>March 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 31, 2023</results_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ABX464, HIV infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT02990325/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT02990325/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ABX464 150mg</title>
          <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
        </group>
        <group group_id="P2">
          <title>ABX464 50mg for 28 Days</title>
          <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
        </group>
        <group group_id="P3">
          <title>ABX464 50mg for 84 Days</title>
          <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ABX464 150 mg Capsules for 28 Days</title>
          <description>ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
        </group>
        <group group_id="B2">
          <title>ABX464 50 mg Capsules for 28 Days</title>
          <description>ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
        </group>
        <group group_id="B3">
          <title>ABX464 50 mg Capsules for 84 Days</title>
          <description>ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve (AUC) of ABX464 in Sera</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28 and Day 84</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) of ABX464 in Sera</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="306.0" spread="46.5"/>
                    <measurement group_id="O2" value="63.7" spread="39.9"/>
                    <measurement group_id="O3" value="63.7" spread="77.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.8" spread="48.7"/>
                    <measurement group_id="O2" value="17.8" spread="60.9"/>
                    <measurement group_id="O3" value="30.3" spread="68.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="28.9" spread="66.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration (Cmax) of ABX464 in Sera</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28 and day 84</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of ABX464 in Sera</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.1" spread="54.5"/>
                    <measurement group_id="O2" value="23.1" spread="45.2"/>
                    <measurement group_id="O3" value="24.5" spread="75.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.9" spread="57.1"/>
                    <measurement group_id="O2" value="9.3" spread="60.3"/>
                    <measurement group_id="O3" value="13.0" spread="76.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="15.6" spread="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera</title>
        <description>Pharmacokinetics parameters</description>
        <time_frame>Day 1, Day 28 and Day 84</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX461 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera</title>
          <description>Pharmacokinetics parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50115.8" spread="41.5"/>
                    <measurement group_id="O2" value="8282.3" spread="37.0"/>
                    <measurement group_id="O3" value="11209.6" spread="66.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48605.0" spread="40.6"/>
                    <measurement group_id="O2" value="4800.6" spread="37.0"/>
                    <measurement group_id="O3" value="13308.8" spread="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="14588.2" spread="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28 and Day 84</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9918.2" spread="33.5"/>
                    <measurement group_id="O2" value="1626.8" spread="36.9"/>
                    <measurement group_id="O3" value="2036.2" spread="62.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7011.1" spread="37.5"/>
                    <measurement group_id="O2" value="695.9" spread="38.6"/>
                    <measurement group_id="O3" value="1705.5" spread="71.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="2150.6" spread="56.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28 and Day 84</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="463.3" spread="55.0"/>
                    <measurement group_id="O2" value="209.4" spread="54.4"/>
                    <measurement group_id="O3" value="203.8" spread="81.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="247.8" spread="75.7"/>
                    <measurement group_id="O2" value="76.4" spread="51.7"/>
                    <measurement group_id="O3" value="72.3" spread="82.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="73.6" spread="57.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28 and Day 84</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1120.7" spread="52.6"/>
                    <measurement group_id="O2" value="594.2" spread="53.2"/>
                    <measurement group_id="O3" value="481.5" spread="78.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="522.4" spread="49.2"/>
                    <measurement group_id="O2" value="156.0" spread="51.8"/>
                    <measurement group_id="O3" value="151.6" spread="74.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="144.9" spread="48.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28 and Day 84</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="585.5" spread="60.3"/>
                    <measurement group_id="O2" value="39.7" spread="90.5"/>
                    <measurement group_id="O3" value="230.0" spread="153.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491.5" spread="73.0"/>
                    <measurement group_id="O2" value="35.6" spread="85.7"/>
                    <measurement group_id="O3" value="125.1" spread="86.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="153.3" spread="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28 and Day 84</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2133.7" spread="42.2"/>
                    <measurement group_id="O2" value="39.2" spread="186.7"/>
                    <measurement group_id="O3" value="835.3" spread="116.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2212.3" spread="58.8"/>
                    <measurement group_id="O2" value="35.0" spread="210.1"/>
                    <measurement group_id="O3" value="697.5" spread="92.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="766.5" spread="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28, Day 56, Day 84 and Day 112</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                    <measurement group_id="O3" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.11"/>
                    <measurement group_id="O2" value="0.1" spread="0.19"/>
                    <measurement group_id="O3" value="0.1" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.1" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 112</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)</title>
        <description>Pharmacokinetic parameters</description>
        <time_frame>Day 1, Day 28, Day 56, Day 84 and Day 112</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg for 28 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
          </group>
          <group group_id="O3">
            <title>ABX464 50mg for 84 Days</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)</title>
          <description>Pharmacokinetic parameters</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="0.1" spread="0.08"/>
                    <measurement group_id="O3" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.04"/>
                    <measurement group_id="O2" value="0.1" spread="0.11"/>
                    <measurement group_id="O3" value="0.1" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.2" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 112</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)</title>
        <description>Viral Load Assessments (HIV-1 RNA copies/ml)</description>
        <time_frame>Day 28, Day 56, Day 84 and Day 112</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. HIV viral measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)</title>
          <description>Viral Load Assessments (HIV-1 RNA copies/ml)</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. HIV viral measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.</population>
          <units>copies/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-1.9" upper_limit="0.1"/>
                    <measurement group_id="O2" value="-2.0" lower_limit="-4.3" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-1.5" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" lower_limit="-3.0" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 112</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.1" lower_limit="-3.7" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CD4+ Counts (Cell/mm^3)</title>
        <description>T-cell determinations</description>
        <time_frame>Day 28, Day 35, Day 56, Day 84, Day 91 and Day 112</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. CD4+ counts measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>CD4+ Counts (Cell/mm^3)</title>
          <description>T-cell determinations</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. CD4+ counts measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.</population>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-130.6" lower_limit="-217.5" upper_limit="-43.6"/>
                    <measurement group_id="O2" value="-34.6" lower_limit="-167.7" upper_limit="98.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-125.6" lower_limit="-266.2" upper_limit="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.6" lower_limit="-202.4" upper_limit="261.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="8.3" lower_limit="-90.2" upper_limit="106.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="23.3" lower_limit="-122.5" upper_limit="169.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 112</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="161.8" lower_limit="59.5" upper_limit="264.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)</title>
        <description>HIV reservoir cells (CD4+)</description>
        <time_frame>Day 28, Day 56, Day 84 and Day 112</time_frame>
        <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. Total HIV-1 DNA reservoir measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.</population>
        <group_list>
          <group group_id="O1">
            <title>ABX464 150mg</title>
            <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
          </group>
          <group group_id="O2">
            <title>ABX464 50mg</title>
            <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
          </group>
        </group_list>
        <measure>
          <title>Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)</title>
          <description>HIV reservoir cells (CD4+)</description>
          <population>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data. Total HIV-1 DNA reservoir measurements were not assessed for cohort 2 subjects as they were HIV non infected subjets.</population>
          <units>copies/10^6 cells</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-86.8" lower_limit="-172.2" upper_limit="-1.3"/>
                    <measurement group_id="O2" value="22.3" lower_limit="-21.7" upper_limit="66.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.1" lower_limit="-139.1" upper_limit="64.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="10.8" lower_limit="-55.3" upper_limit="76.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 112</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="95.6" lower_limit="26.1" upper_limit="165.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline up to 112 days</time_frame>
      <desc>Subjects who had received at least 1 dose of the Investigational Medicinal Product and who have at least baseline data.</desc>
      <group_list>
        <group group_id="E1">
          <title>ABX464 150mg</title>
          <description>ABX464, 50mg per Capsule Three Capsules per day for 28 days&#xD;
ABX464 150mg: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)</description>
        </group>
        <group group_id="E2">
          <title>ABX464 50mg for 28 Days</title>
          <description>ABX464, 50mg per Capsule One Capsule per day for 28 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)</description>
        </group>
        <group group_id="E3">
          <title>ABX464 50mg for 84 Days</title>
          <description>ABX464, 50mg per Capsule One Capsule per day for 84 days&#xD;
ABX464 50mg: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperamylasaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Hyperlipaseamia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="11"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nightmare</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sophie Biguenet</name_or_title>
      <organization>Abivax</organization>
      <phone>+33 (0) 1 53 83 08 41</phone>
      <email>sophie.biguenet@abivax.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02990325
org study id: ABX464-005
nct id: NCT02990325
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological
      sequelae associated with exposure to ABX464 and to explore selected immunological endpoints,
      compartmental pharmacokinetics, and pharmacodynamics.
The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological
      sequelae associated with exposure to ABX464 and to explore selected immunological endpoints,
      compartmental pharmacokinetics, and pharmacodynamics. The site will screen and enroll 12
      HIV-infected subjects who will receive 150 mg ABX464 orally once daily for 28 days (Cohort
      1). Following completion of this cohort a further 24 subjects will be enrolled: 12
      HIV-uninfected subjects will receive 50 mg ABX464 orally once daily for 28 days (Cohort 2)
      and 12 HIV-infected subjects (Cohort 3) who will 50 mg ABX464 orally once daily for 84 days.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Curve (AUC) of ABX464 in Sera
time frame: Day 1, Day 28 and Day 84
description: Pharmacokinetic parameters
measure: Maximum Observed Concentration (Cmax) of ABX464 in Sera
time frame: Day 1, Day 28 and day 84
description: Pharmacokinetic parameters
measure: Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
time frame: Day 1, Day 28 and Day 84
description: Pharmacokinetics parameters
measure: Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Sera
time frame: Day 1, Day 28 and Day 84
description: Pharmacokinetic parameters
measure: Maximum Observed Concentration (Cmax) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
time frame: Day 1, Day 28 and Day 84
description: Pharmacokinetic parameters
measure: Area Under the Curve (AUC) of ABX464 in Peripheral Blood Mononuclear Cells (PBMC)
time frame: Day 1, Day 28 and Day 84
description: Pharmacokinetic parameters
measure: Maximum Observed Concentration (Cmax) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
time frame: Day 1, Day 28 and Day 84
description: Pharmacokinetic parameters
measure: Area Under the Curve (AUC) of ABX464 Metabolite (ABX464-N-Glucuronide) in Peripheral Blood Mononuclear Cells (PBMC)
time frame: Day 1, Day 28 and Day 84
description: Pharmacokinetic parameters
measure: Concentration of ABX464 in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
time frame: Day 1, Day 28, Day 56, Day 84 and Day 112
description: Pharmacokinetic parameters
measure: Concentration of ABX464 Metabolite (ABX464-N-Glucuronide) in Rectal Tissue (Measured Only at Pre-infusion Timepoint)
time frame: Day 1, Day 28, Day 56, Day 84 and Day 112
description: Pharmacokinetic parameters
measure: Mean Change From Baseline in Plasma Viral Load (Ultrasensitive Assay)
time frame: Day 28, Day 56, Day 84 and Day 112
description: Viral Load Assessments (HIV-1 RNA copies/ml)
measure: CD4+ Counts (Cell/mm^3)
time frame: Day 28, Day 35, Day 56, Day 84, Day 91 and Day 112
description: T-cell determinations
measure: Total HIV-1 DNA Reservoir in Peripheral Blood Mononuclear Cells (PBMC)
time frame: Day 28, Day 56, Day 84 and Day 112
description: HIV reservoir cells (CD4+)
arm group label: ABX464 150mg
arm group type: Experimental
description: ABX464, 50mg per Capsule Three Capsules per day for 28 days
arm group label: ABX464 50mg for 28 days
arm group type: Experimental
description: ABX464, 50mg per Capsule One Capsule per day for 28 days
arm group label: ABX464 50mg for 84 days
arm group type: Experimental
description: ABX464, 50mg per Capsule One Capsule per day for 84 days
intervention type: Drug
intervention name: ABX464 150mg
description: ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
arm group label: ABX464 150mg
intervention type: Drug
intervention name: ABX464 50mg
description: ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
arm group label: ABX464 50mg for 28 days
intervention type: Drug
intervention name: ABX464 50mg
description: ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)
arm group label: ABX464 50mg for 84 days
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paul GINESTE, PhD
role: Study Director
affiliation: Abivax S.A.
facility: 
country: Spain
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 