<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/NCT02217904</url>
  </required_header>
  <id_info>
    <org_study_id>8591-003</org_study_id>
    <secondary_id>2014-002192-28</secondary_id>
    <secondary_id>MK-8591-003</secondary_id>
    <nct_id>NCT02217904</nct_id>
  </id_info>
  <brief_title>A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)</brief_title>
  <official_title>A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8591 Monotherapy in Anti-Retroviral Therapy (ART)-Naive, HIV-1 Infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral&#xD;
      therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human&#xD;
      immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a&#xD;
      safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1&#xD;
      ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5&#xD;
      log (base10) copies/mL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2015</start_date>
  <completion_date type="Actual">May 11, 2017</completion_date>
  <primary_completion_date type="Actual">May 11, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose</measure>
    <time_frame>Baseline and 168 hours (7 days) post-dose</time_frame>
    <description>Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With One or More Adverse Events</measure>
    <time_frame>Up to 21 days post-dose</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)</measure>
    <time_frame>4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.</time_frame>
    <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</measure>
    <time_frame>4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.</time_frame>
    <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)</measure>
    <time_frame>168 hours after islatravir administration</time_frame>
    <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</measure>
    <time_frame>4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.</time_frame>
    <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</measure>
    <time_frame>4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.</time_frame>
    <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)</measure>
    <time_frame>Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated.</time_frame>
    <description>Blood was collected for the determination of AUC0-168hr of islatravir in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of Islatravir</measure>
    <time_frame>Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration</time_frame>
    <description>Blood was collected for the determination of Cmax of islatravir in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Plasma Concentration (Tmax) of Islatravir</measure>
    <time_frame>Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration</time_frame>
    <description>Blood was collected for the determination of Tmax of islatravir in plasma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma</measure>
    <time_frame>Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration</time_frame>
    <description>Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>HIV-1</condition>
  <arm_group>
    <arm_group_label>Islatravir 1 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of islatravir 1 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Islatravir 2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of islatravir 2 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Islatravir 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of islatravir 10 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Islatravir 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of islatravir 30 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Islatravir 0.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of islatravir 0.5 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Islatravir 0.25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of islatravir 0.25 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Islatravir 30 mg Extended Observation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of 30 mg islatravir administered following &gt;8 hour fast. Participants will be closely monitored for viral load for up to approximately 21 days prior to starting standard of care ART.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1 mg islatravir</intervention_name>
    <description>Single oral dose of 1 mg islatravir administered following ≥8 hour fast</description>
    <arm_group_label>Islatravir 1 mg</arm_group_label>
    <other_name>MK-8591</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2 mg islatravir</intervention_name>
    <description>Single oral dose of 2 mg islatravir administered following ≥8 hour fast</description>
    <arm_group_label>Islatravir 2 mg</arm_group_label>
    <other_name>MK-8591</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10 mg islatravir</intervention_name>
    <description>Single oral dose of 10 mg islatravir administered following ≥8 hour fast</description>
    <arm_group_label>Islatravir 10 mg</arm_group_label>
    <other_name>MK-8591</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>30 mg islatravir</intervention_name>
    <description>Single oral dose of 30 mg islatravir administered following ≥8 hour fast</description>
    <arm_group_label>Islatravir 30 mg</arm_group_label>
    <arm_group_label>Islatravir 30 mg Extended Observation</arm_group_label>
    <other_name>MK-8591</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.5 mg islatravir</intervention_name>
    <description>Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast</description>
    <arm_group_label>Islatravir 0.5 mg</arm_group_label>
    <other_name>MK-8591</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.25 mg islatravir</intervention_name>
    <description>Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast</description>
    <arm_group_label>Islatravir 0.25 mg</arm_group_label>
    <other_name>MK-8591</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-pregnant, non-breast feeding, postmenopausal or surgically sterile female&#xD;
&#xD;
          -  Female with reproductive potential agrees to use (or have male partner use) two&#xD;
             acceptable methods of birth control&#xD;
&#xD;
          -  Male agrees to use acceptable method of contraception during study and for 90 days&#xD;
             after last dose of trial drug&#xD;
&#xD;
          -  Has stable baseline health, other than HIV infection&#xD;
&#xD;
          -  Has no significantly abnormal electrocardiogram&#xD;
&#xD;
          -  Is HIV-1 positive&#xD;
&#xD;
          -  Have a screening plasma HIV-1 RNA ≥ 10,000 copies/mL within 30 days prior to the&#xD;
             treatment phase of this study. For inclusion in Panel Islatravir Extended Observation,&#xD;
             participants must also have a screening plasma HIV-1 RNA ≤ 25,000 copies/mL within 30&#xD;
             days prior to the treatment phase.&#xD;
&#xD;
          -  Is ART naive&#xD;
&#xD;
          -  Has not received any investigational agent or marketed ART within 30 days of trial&#xD;
             drug administration&#xD;
&#xD;
          -  Is diagnosed with HIV-1 infection &gt;= 3 months prior to screening&#xD;
&#xD;
          -  Is willing to receive no other ART during treatment phase of study&#xD;
&#xD;
          -  Has no evidence of mutations conferring resistance to nucleoside reverse transcriptase&#xD;
             inhibitors (NRTIs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is mentally or legally institutionalized/incapacitated, or has significant emotional&#xD;
             problems, or has a history of clinically significant psychiatric disorder of the last&#xD;
             5 years&#xD;
&#xD;
          -  Has a history of clinically significant endocrine, gastrointestinal, cardiovascular,&#xD;
             hematological, hepatic, immunological (outside of HIV-1 infection), renal,&#xD;
             respiratory, genitourinary, major neurological abnormalities or diseases&#xD;
&#xD;
          -  Has a history of cancer (malignancy)&#xD;
&#xD;
          -  Has a history of significant multiple and/or severe allergies, or had an anaphylactic&#xD;
             reaction to drugs or food&#xD;
&#xD;
          -  Is positive for hepatitis B surface antigen&#xD;
&#xD;
          -  Has a history of chronic Hepatitis C&#xD;
&#xD;
          -  Had major surgery or lost 500 mL of blood with 4 weeks prior to screening visit&#xD;
&#xD;
          -  Has participated in another investigational trial within 4 weeks prior to dosing visit&#xD;
&#xD;
          -  Will use any medications, prescribed drugs, or herbal remedies 4 weeks prior to dosing&#xD;
             of trial drug, up to the post-trial visit&#xD;
&#xD;
          -  Consumes excessive amounts of alcohol, caffeinated beverages, or tobacco products&#xD;
&#xD;
          -  Uses illicit drugs or has a history of drug abuse within the prior 2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>May 2, 2018</results_first_submitted>
  <results_first_submitted_qc>May 2, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 3, 2018</results_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Islatravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02217904/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Additional panels (F: 0.25 mg islatravir; and G: 30 mg islatravir Extended Observation) were initially planned but were not conducted.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Panel A: 10 mg Islatravir</title>
          <description>Participants received a single dose of 10 mg islatravir.</description>
        </group>
        <group group_id="P2">
          <title>Panel B: 2 mg Islatravir</title>
          <description>Participants received a single dose of 2 mg islatravir.</description>
        </group>
        <group group_id="P3">
          <title>Panel C: 30 mg Islatravir</title>
          <description>Participants received a single dose of 30 mg islatravir.</description>
        </group>
        <group group_id="P4">
          <title>Panel D: 1 mg Islatravir</title>
          <description>Participants received a single dose of 1 mg islatravir.</description>
        </group>
        <group group_id="P5">
          <title>Panel E: 0.5 mg Islatravir</title>
          <description>Participants received a single dose of 0.5 mg islatravir.</description>
        </group>
        <group group_id="P6">
          <title>Panel F: 0.25 mg Islatravir</title>
          <description>Participants received a single does of 0.25 mg islatravir.</description>
        </group>
        <group group_id="P7">
          <title>Panel G: 30 mg Islatravir Extended Observation</title>
          <description>Participants received a single does of 30 mg islatravir.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Panel A: 10 mg Islatravir</title>
          <description>Participants received a single dose of 10 mg islatravir.</description>
        </group>
        <group group_id="B2">
          <title>Panel B: 2 mg Islatravir</title>
          <description>Participants received a single dose of 2 mg islatravir.</description>
        </group>
        <group group_id="B3">
          <title>Panel C: 30 mg Islatravir</title>
          <description>Participants received a single dose of 30 mg islatravir.</description>
        </group>
        <group group_id="B4">
          <title>Panel D: 1 mg Islatravir</title>
          <description>Participants received a single dose of 1 mg islatravir.</description>
        </group>
        <group group_id="B5">
          <title>Panel E: 0.5 mg Islatravir</title>
          <description>Participants received a single dose of 0.5 mg islatravir.</description>
        </group>
        <group group_id="B6">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.5" spread="10.0"/>
                    <measurement group_id="B2" value="42.2" spread="9.8"/>
                    <measurement group_id="B3" value="35.5" spread="9.1"/>
                    <measurement group_id="B4" value="32.7" spread="12.7"/>
                    <measurement group_id="B5" value="35.5" spread="11.3"/>
                    <measurement group_id="B6" value="35.5" spread="10.6"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="27"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" 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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" 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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="29"/>
                  </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 group_id="B5" value="0"/>
                    <measurement group_id="B6" 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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Plasma HIV-1 Ribonucleic Acid (RNA)</title>
          <units>log10 copies/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.68" spread="0.39"/>
                    <measurement group_id="B2" value="4.7" spread="0.25"/>
                    <measurement group_id="B3" value="4.17" spread="0.41"/>
                    <measurement group_id="B4" value="4.66" spread="0.2"/>
                    <measurement group_id="B5" value="4.59" spread="0.5"/>
                    <measurement group_id="B6" value="4.56" spread="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose</title>
        <description>Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.</description>
        <time_frame>Baseline and 168 hours (7 days) post-dose</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had available plasma HIV-1 RNA data at baseline and 168 hours post-dose, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose</title>
          <description>Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had available plasma HIV-1 RNA data at baseline and 168 hours post-dose, and were evaluable for the outcome measure.</population>
          <units>log10 copies/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.67" lower_limit="-1.92" upper_limit="-1.42"/>
                    <measurement group_id="O2" value="-1.35" lower_limit="-1.60" upper_limit="-1.10"/>
                    <measurement group_id="O3" value="-1.60" lower_limit="-1.85" upper_limit="-1.34"/>
                    <measurement group_id="O4" value="-1.30" lower_limit="-1.55" upper_limit="-1.05"/>
                    <measurement group_id="O5" value="-1.20" lower_limit="-1.46" upper_limit="-0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Posterior mean difference</param_type>
            <param_value>-1.64</param_value>
            <estimate_desc>Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was &gt;99%.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Posterior mean difference</param_type>
            <param_value>-1.32</param_value>
            <estimate_desc>Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was &gt;99%.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Posterior mean difference</param_type>
            <param_value>-1.57</param_value>
            <estimate_desc>Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was &gt;99%.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Posterior mean difference</param_type>
            <param_value>-1.28</param_value>
            <estimate_desc>Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was &gt;99%.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Posterior mean difference</param_type>
            <param_value>-1.18</param_value>
            <estimate_desc>Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was &gt;99%.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One or More Adverse Events</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.</description>
        <time_frame>Up to 21 days post-dose</time_frame>
        <population>All participants who received at least one dose of investigational drug</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One or More Adverse Events</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.</description>
          <population>All participants who received at least one dose of investigational drug</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)</title>
        <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr.</description>
        <time_frame>4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had AUC0-168hr of triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)</title>
          <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had AUC0-168hr of triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
          <units>hr*pmol/10^6 cells</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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="227" spread="33.3"/>
                    <measurement group_id="O2" value="46.9" spread="38.1"/>
                    <measurement group_id="O3" value="926" spread="47.7"/>
                    <measurement group_id="O4" value="35.9" spread="27.6"/>
                    <measurement group_id="O5" value="23.1" spread="83.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</title>
        <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax.</description>
        <time_frame>4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Cmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</title>
          <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Cmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
          <units>pmol/10^6 cells</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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" spread="49.9"/>
                    <measurement group_id="O2" value="0.495" spread="62.9"/>
                    <measurement group_id="O3" value="8.9" spread="60.3"/>
                    <measurement group_id="O4" value="0.408" spread="49.3"/>
                    <measurement group_id="O5" value="0.263" spread="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)</title>
        <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr.</description>
        <time_frame>168 hours after islatravir administration</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had C168hr of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)</title>
          <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had C168hr of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
          <units>pmol/10^6 cells</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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.983" spread="26"/>
                    <measurement group_id="O2" value="0.188" spread="39.2"/>
                    <measurement group_id="O3" value="4.83" spread="85.9"/>
                    <measurement group_id="O4" value="0.164" spread="31.4"/>
                    <measurement group_id="O5" value="0.116" spread="85.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</title>
        <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax.</description>
        <time_frame>4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Tmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</title>
          <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Tmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="12" upper_limit="240"/>
                    <measurement group_id="O2" value="8" lower_limit="4" upper_limit="144"/>
                    <measurement group_id="O3" value="24" lower_limit="4" upper_limit="96"/>
                    <measurement group_id="O4" value="8" lower_limit="4" upper_limit="24"/>
                    <measurement group_id="O5" value="12" lower_limit="4" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</title>
        <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2.</description>
        <time_frame>4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells</title>
          <description>Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.</population>
          <units>Hours</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="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128" spread="42.2"/>
                    <measurement group_id="O2" value="120" spread="14.7"/>
                    <measurement group_id="O3" value="78.5" spread="31.4"/>
                    <measurement group_id="O4" value="118" spread="16.1"/>
                    <measurement group_id="O5" value="95.3" spread="38.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)</title>
        <description>Blood was collected for the determination of AUC0-168hr of islatravir in plasma.</description>
        <time_frame>Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated.</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma AUC-168hr of islatravir data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)</title>
          <description>Blood was collected for the determination of AUC0-168hr of islatravir in plasma.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma AUC-168hr of islatravir data available, and were evaluable for the outcome measure.</population>
          <units>hr*nM</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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1020" spread="16.8"/>
                    <measurement group_id="O2" value="143" spread="39.6"/>
                    <measurement group_id="O3" value="3020" spread="24.6"/>
                    <measurement group_id="O4" value="88.3" spread="33.8"/>
                    <measurement group_id="O5" value="38.3" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) of Islatravir</title>
        <description>Blood was collected for the determination of Cmax of islatravir in plasma.</description>
        <time_frame>Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Cmax of islatravir data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) of Islatravir</title>
          <description>Blood was collected for the determination of Cmax of islatravir in plasma.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Cmax of islatravir data available, and were evaluable for the outcome measure.</population>
          <units>nM</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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235" spread="32.1"/>
                    <measurement group_id="O2" value="43.8" spread="51.2"/>
                    <measurement group_id="O3" value="678" spread="29.6"/>
                    <measurement group_id="O4" value="38.8" spread="31.3"/>
                    <measurement group_id="O5" value="20.3" spread="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Plasma Concentration (Tmax) of Islatravir</title>
        <description>Blood was collected for the determination of Tmax of islatravir in plasma.</description>
        <time_frame>Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Tmax of islatravir data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Plasma Concentration (Tmax) of Islatravir</title>
          <description>Blood was collected for the determination of Tmax of islatravir in plasma.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Tmax of islatravir data available, and were evaluable for the outcome measure.</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0.5" upper_limit="1"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.5" upper_limit="1"/>
                    <measurement group_id="O3" value="0.75" lower_limit="0.5" upper_limit="1"/>
                    <measurement group_id="O4" value="0.5" lower_limit="0.5" upper_limit="1"/>
                    <measurement group_id="O5" value="0.5" lower_limit="0.25" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma</title>
        <description>Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma.</description>
        <time_frame>Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration</time_frame>
        <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir in plasma data available, and were evaluable for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Panel A: 10 mg Islatravir</title>
            <description>Participants received a single dose of 10 mg islatravir.</description>
          </group>
          <group group_id="O2">
            <title>Panel B: 2 mg Islatravir</title>
            <description>Participants received a single dose of 2 mg islatravir.</description>
          </group>
          <group group_id="O3">
            <title>Panel C: 30 mg Islatravir</title>
            <description>Participants received a single dose of 30 mg islatravir.</description>
          </group>
          <group group_id="O4">
            <title>Panel D: 1 mg Islatravir</title>
            <description>Participants received a single dose of 1 mg islatravir.</description>
          </group>
          <group group_id="O5">
            <title>Panel E: 0.5 mg Islatravir</title>
            <description>Participants received a single dose of 0.5 mg islatravir.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma</title>
          <description>Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir in plasma data available, and were evaluable for the outcome measure.</population>
          <units>Hours</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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.7" spread="15.4"/>
                    <measurement group_id="O2" value="47.4" spread="74.6"/>
                    <measurement group_id="O3" value="56.8" spread="11.2"/>
                    <measurement group_id="O4" value="10.4" spread="144"/>
                    <measurement group_id="O5" value="2.31" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 21 days following administration of investigational drug</time_frame>
      <desc>All participants who received at least one dose of investigational drug</desc>
      <group_list>
        <group group_id="E1">
          <title>Panel A: 10 mg Islatravir</title>
          <description>Participants received a single dose of 10 mg islatravir.</description>
        </group>
        <group group_id="E2">
          <title>Panel B: 2 mg Islatravir</title>
          <description>Participants received a single dose of 2 mg islatravir.</description>
        </group>
        <group group_id="E3">
          <title>Panel C: 30 mg Islatravir</title>
          <description>Participants received a single dose of 30 mg islatravir.</description>
        </group>
        <group group_id="E4">
          <title>Panel D: 1 mg Islatravir</title>
          <description>Participants received a single dose of 1 mg islatravir.</description>
        </group>
        <group group_id="E5">
          <title>Panel E: 0.5 mg Islatravir</title>
          <description>Participants received a single dose of 0.5 mg islatravir.</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <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="5" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Oral mucosa erosion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sensory disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Apathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT02217904
org study id: 8591-003
secondary id: 2014-002192-28
secondary id: MK-8591-003
nct id: NCT02217904
lead sponsor: 
has dmc: No
This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral
      therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human
      immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a
      safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1
      ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5
      log (base10) copies/mL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose
time frame: Baseline and 168 hours (7 days) post-dose
description: Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.
measure: Number of Participants With One or More Adverse Events
time frame: Up to 21 days post-dose
description: An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
measure: Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)
time frame: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
description: Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr.
measure: Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
time frame: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
description: Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax.
measure: Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)
time frame: 168 hours after islatravir administration
description: Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr.
measure: Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
time frame: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
description: Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax.
measure: Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells
time frame: 4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.
description: Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2.
measure: Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)
time frame: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated.
description: Blood was collected for the determination of AUC0-168hr of islatravir in plasma.
measure: Maximum Plasma Concentration (Cmax) of Islatravir
time frame: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration
description: Blood was collected for the determination of Cmax of islatravir in plasma.
measure: Time to Maximum Plasma Concentration (Tmax) of Islatravir
time frame: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration
description: Blood was collected for the determination of Tmax of islatravir in plasma.
measure: Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma
time frame: Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration
description: Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma.
arm group label: Islatravir 1 mg
arm group type: Experimental
description: Single oral dose of islatravir 1 mg
arm group label: Islatravir 2 mg
arm group type: Experimental
description: Single oral dose of islatravir 2 mg
arm group label: Islatravir 10 mg
arm group type: Experimental
description: Single oral dose of islatravir 10 mg
arm group label: Islatravir 30 mg
arm group type: Experimental
description: Single oral dose of islatravir 30 mg
arm group label: Islatravir 0.5 mg
arm group type: Experimental
description: Single oral dose of islatravir 0.5 mg
arm group label: Islatravir 0.25 mg
arm group type: Experimental
description: Single oral dose of islatravir 0.25 mg
arm group label: Islatravir 30 mg Extended Observation
arm group type: Experimental
description: Single oral dose of 30 mg islatravir administered following >8 hour fast. Participants will be closely monitored for viral load for up to approximately 21 days prior to starting standard of care ART.
intervention type: Drug
intervention name: 1 mg islatravir
description: Single oral dose of 1 mg islatravir administered following ≥8 hour fast
arm group label: Islatravir 1 mg
other name: MK-8591
intervention type: Drug
intervention name: 2 mg islatravir
description: Single oral dose of 2 mg islatravir administered following ≥8 hour fast
arm group label: Islatravir 2 mg
other name: MK-8591
intervention type: Drug
intervention name: 10 mg islatravir
description: Single oral dose of 10 mg islatravir administered following ≥8 hour fast
arm group label: Islatravir 10 mg
other name: MK-8591
intervention type: Drug
intervention name: 30 mg islatravir
description: Single oral dose of 30 mg islatravir administered following ≥8 hour fast
arm group label: Islatravir 30 mg
arm group label: Islatravir 30 mg Extended Observation
other name: MK-8591
intervention type: Drug
intervention name: 0.5 mg islatravir
description: Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast
arm group label: Islatravir 0.5 mg
other name: MK-8591
intervention type: Drug
intervention name: 0.25 mg islatravir
description: Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast
arm group label: Islatravir 0.25 mg
other name: MK-8591
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Germany
responsible party type: Sponsor
mesh term: Islatravir
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 