<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/NCT03272347</url>
  </required_header>
  <id_info>
    <org_study_id>8591-011</org_study_id>
    <secondary_id>2017-000437-32</secondary_id>
    <nct_id>NCT03272347</nct_id>
  </id_info>
  <brief_title>Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)</brief_title>
  <official_title>A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) in HIV-1-Infected Treatment-Naïve Adults</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>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety, tolerability, antiretroviral activity, and&#xD;
      pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and&#xD;
      lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human&#xD;
      immunodeficiency virus type 1 (HIV-1) infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">March 9, 2022</completion_date>
  <primary_completion_date type="Actual">March 8, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Masking in Part 1, including matching placebo. Masking only to dose in Part 2. No masking in Parts 3 and 4.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Experiencing Adverse Events (AEs) up to Week 144</measure>
    <time_frame>Up to 144 weeks</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Discontinuing Study Drug Due to AEs up to Week 144</measure>
    <time_frame>Up to 144 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</measure>
    <time_frame>Up to 24 weeks after 3TC and Placebo are discontinued from the regimen (up to approximately 60 weeks after initiating treatment)</time_frame>
    <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen</measure>
    <time_frame>Up to 48 weeks</time_frame>
    <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)</measure>
    <time_frame>Up to Week 192</time_frame>
    <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA &lt;50 copies in Part 4 are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CD4+ T-cell Count at Week 48</measure>
    <time_frame>Baseline and Week 48</time_frame>
    <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CD4+ T-cell Count at Week 96</measure>
    <time_frame>Baseline and Week 96</time_frame>
    <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CD4+ T-cell Count at Week 144</measure>
    <time_frame>Baseline and Week 144</time_frame>
    <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)</measure>
    <time_frame>Baseline and Week 192</time_frame>
    <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing AEs From Week 96 Through Study Duration</measure>
    <time_frame>Week 96 up to Week 192</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration</measure>
    <time_frame>Week 96 up to Week 192</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)</measure>
    <time_frame>Week 144 up to Week 192</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced AEs during Part 4 are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)</measure>
    <time_frame>Week 144 up to Week 192</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued the study drug due to AEs in Part 4 are reported.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>HIV-1 Infection</condition>
  <arm_group>
    <arm_group_label>Islatravir 0.25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be treated once daily (QD) with 0.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Islatravir 0.75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and will continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Islatravir 2.25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and will continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DOR/3TC/TDF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. Between week 24 through week 52 placebo treatments may be discontinued and participants will receive only DOR/3TC/TDF QD open label up to Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Islatravir</intervention_name>
    <description>Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.</description>
    <arm_group_label>Islatravir 0.25 mg</arm_group_label>
    <arm_group_label>Islatravir 0.75 mg</arm_group_label>
    <arm_group_label>Islatravir 2.25 mg</arm_group_label>
    <other_name>MK-8591</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Islatravir</intervention_name>
    <description>Placebo to islatravir is orally administered QD in capsule form for up to 52 weeks</description>
    <arm_group_label>DOR/3TC/TDF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doravirine</intervention_name>
    <description>Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks</description>
    <arm_group_label>Islatravir 0.25 mg</arm_group_label>
    <arm_group_label>Islatravir 0.75 mg</arm_group_label>
    <arm_group_label>Islatravir 2.25 mg</arm_group_label>
    <other_name>MK-1439</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Doravirine</intervention_name>
    <description>Placebo to Doravirine is orally administered QD in tablet form for up to 52 weeks</description>
    <arm_group_label>DOR/3TC/TDF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lamivudine</intervention_name>
    <description>Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks</description>
    <arm_group_label>Islatravir 0.25 mg</arm_group_label>
    <arm_group_label>Islatravir 0.75 mg</arm_group_label>
    <arm_group_label>Islatravir 2.25 mg</arm_group_label>
    <other_name>3TC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Lamivudine</intervention_name>
    <description>Placebo to Lamivudine is orally administered QD in tablet form for up to 52 weeks</description>
    <arm_group_label>DOR/3TC/TDF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate</intervention_name>
    <description>Fixed dose combination of 100 mg doravirine + 300 mg lamivudine + 300 mg tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 144 weeks.</description>
    <arm_group_label>DOR/3TC/TDF</arm_group_label>
    <other_name>MK-1439A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate</intervention_name>
    <description>Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks</description>
    <arm_group_label>Islatravir 0.25 mg</arm_group_label>
    <arm_group_label>Islatravir 0.75 mg</arm_group_label>
    <arm_group_label>Islatravir 2.25 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doravirine/Islatravir</intervention_name>
    <description>Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks</description>
    <arm_group_label>DOR/3TC/TDF</arm_group_label>
    <arm_group_label>Islatravir 0.25 mg</arm_group_label>
    <arm_group_label>Islatravir 0.75 mg</arm_group_label>
    <arm_group_label>Islatravir 2.25 mg</arm_group_label>
    <other_name>MK-8591A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has HIV-1 infection&#xD;
&#xD;
          -  Is naïve to anti-retroviral therapy (ART).&#xD;
&#xD;
          -  Is clinically stable, with no signs or symptoms of acute infection, at the time of&#xD;
             entry into the study&#xD;
&#xD;
          -  Female is not pregnant, not breastfeeding, not a woman of childbearing potential&#xD;
             (WOCBP); but if WOCBP agrees to follow the contraceptive guidance&#xD;
&#xD;
          -  All participants, male and female, agree to use barrier methods of contraception when&#xD;
             engaged in any sexual activity during treatment and for 6 weeks following treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is a user of recreational or illicit drugs or has had a history of drug or alcohol&#xD;
             abuse or dependence that may interfere with trial participation&#xD;
&#xD;
          -  Has significant hypersensitivity or other contraindication to any of the components of&#xD;
             the study drugs&#xD;
&#xD;
          -  Has a history of malignancy ≤5 years prior&#xD;
&#xD;
          -  Female expects to donate eggs at any time during the study&#xD;
&#xD;
          -  Is breastfeeding or expecting to conceive&#xD;
&#xD;
          -  A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of&#xD;
             study treatment&#xD;
&#xD;
          -  Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an&#xD;
             agent that is active against HIV-1&#xD;
&#xD;
          -  Has used systemic immunosuppressive therapy or immune modulators within 30 days prior&#xD;
             to treatment in this study or is anticipated to need them during the course of the&#xD;
             study&#xD;
&#xD;
          -  Requires any of the following prohibited medications: Carbamazepine, Phenobarbital,&#xD;
             Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John's Wort, Modafinil, Bosentan,&#xD;
             Nafcillin, Pentostatin&#xD;
&#xD;
          -  Is currently participating in or has participated in an interventional clinical trial&#xD;
             with an investigational compound or device within 30 days of signing informed consent&#xD;
             to participate in this current trial&#xD;
&#xD;
          -  Has a documented or known virologic resistance to any approved HIV-1 reverse&#xD;
             transcriptase inhibitor, protease inhibitor, integrase inhibitor&#xD;
&#xD;
          -  Has active hepatitis C virus (HCV) coinfection defined as detectable HCV RNA or HBV&#xD;
             co-infection defined as hepatitis B surface antigen [HBsAg]-positive&#xD;
&#xD;
          -  Has a current (active) diagnosis of acute hepatitis due to any cause&#xD;
&#xD;
          -  Has previously been randomized in a study and received islatravir (MK-8591), DOR,&#xD;
             Doravirine, Tenofovir, Lamivudine, or 3TC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pueblo Family Physicians ( Site 0119)</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University California / Davis ( Site 0101)</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whitman Walker Clinic ( Site 0108)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Immunology Center (OIC) ( Site 0105)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northstar Medical Center ( Site 0102)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City CARE Clinic ( Site 0106)</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Hope Foundation, Inc. ( Site 0116)</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Infectious Diseases Consultants, PA ( Site 0103)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tarrant County Infectious Disease Associates ( Site 0112)</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Crofoot Research Center, Inc. ( Site 0118)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Arauco Salud ( Site 0200)</name>
      <address>
        <city>Santiago</city>
        <state>RM</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biomedica Research Group ( Site 0202)</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Hernan Henriquez Aravena ( Site 0203)</name>
      <address>
        <city>Temuco</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Avicenne ( Site 2302)</name>
      <address>
        <city>Bobigny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint-Andre ( Site 2307)</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hotel Dieu ( Site 2308)</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice Hopital Archet 1 ( Site 2303)</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Bichat - Claude Bernard ( Site 2309)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pitie Salpetriere ( Site 2305)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Louis ( Site 2306)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Tourcoing ( Site 2301)</name>
      <address>
        <city>Tourcoing</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brighton and Sussex University Hospitals NHS Trust ( Site 2105)</name>
      <address>
        <city>Brighton</city>
        <state>East Sussex</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital ( Site 2101)</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal London Hospital ( Site 2103)</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Free London NHS Foundation Trust ( Site 2102)</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Manchester General Hospital ( Site 2104)</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
    <country>France</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <results_first_submitted>February 23, 2022</results_first_submitted>
  <results_first_submitted_qc>March 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2022</results_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</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>Tenofovir</mesh_term>
    <mesh_term>Lamivudine</mesh_term>
    <mesh_term>Islatravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/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>July 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03272347/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Treatment-naïve participants ≥18 years of age with human immunodeficiency virus type 1 (HIV-1) were enrolled in this study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Islatravir 0.25 mg</title>
          <description>In Part 1, participants were treated once daily (QD) with 0.25 mg islatravir, 100 mg doravirine (DOR), 300 mg lamivudine (3TC), and placebo to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no Protocol-defined Virologic Failure (PDVF) discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
        </group>
        <group group_id="P2">
          <title>Islatravir 0.75 mg</title>
          <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
        </group>
        <group group_id="P3">
          <title>Islatravir 2.25 mg</title>
          <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
        </group>
        <group group_id="P4">
          <title>DOR/3TC/TDF</title>
          <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Islatravir 0.25 mg</title>
          <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
        </group>
        <group group_id="B2">
          <title>Islatravir 0.75 mg</title>
          <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
        </group>
        <group group_id="B3">
          <title>Islatravir 2.25 mg</title>
          <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
        </group>
        <group group_id="B4">
          <title>DOR/3TC/TDF</title>
          <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
        </group>
        <group group_id="B5">
          <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="31"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="31"/>
            <count group_id="B5" value="123"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.3" spread="13.3"/>
                    <measurement group_id="B2" value="30.0" spread="9.0"/>
                    <measurement group_id="B3" value="32.4" spread="11.8"/>
                    <measurement group_id="B4" value="29.4" spread="8.9"/>
                    <measurement group_id="B5" value="31.0" spread="10.9"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="113"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_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="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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="93"/>
                  </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="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4+ T-Cell Count</title>
          <population>Two untreated participants from the Islatravir 0.25 mg treatment group were not analyzed.</population>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="450.8" spread="170.0"/>
                    <measurement group_id="B2" value="538.5" spread="165.5"/>
                    <measurement group_id="B3" value="469.6" spread="203.3"/>
                    <measurement group_id="B4" value="508.5" spread="206.8"/>
                    <measurement group_id="B5" value="492.1" spread="188.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with &lt;=100,000 copies/mL of HIV-1 RNA</title>
          <description>Number of participants at screening with &lt;=100,000 copies/mL of HIV-1 RNA</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with &gt;100,000 copies/mL of HIV-1 RNA</title>
          <description>Number of participants at screening with &gt;100,000 copies/mL of HIV-1 RNA</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="31"/>
                    <count group_id="B4" value="31"/>
                    <count group_id="B5" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL at Week 24</title>
        <description>Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.</description>
        <time_frame>Week 24</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL at Week 24</title>
          <description>Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.</description>
          <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.1"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="90.3"/>
                    <measurement group_id="O4" value="90.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% confidence intervals (CIs) were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.5</ci_lower_limit>
            <ci_upper_limit>18.3</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>9.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.8</ci_lower_limit>
            <ci_upper_limit>23.0</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.0</ci_lower_limit>
            <ci_upper_limit>16.3</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL at Week 48</title>
        <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.</description>
        <time_frame>Week 48</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL at Week 48</title>
          <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.</description>
          <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.7"/>
                    <measurement group_id="O2" value="90.0"/>
                    <measurement group_id="O3" value="77.4"/>
                    <measurement group_id="O4" value="83.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>6.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.2</ci_lower_limit>
            <ci_upper_limit>24.4</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>6.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.2</ci_lower_limit>
            <ci_upper_limit>24.6</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-6.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.1</ci_lower_limit>
            <ci_upper_limit>14.8</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing Adverse Events (AEs) up to Week 144</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
        <time_frame>Up to 144 weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Adverse Events (AEs) up to Week 144</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
          <population>All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</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="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.7</ci_lower_limit>
            <ci_upper_limit>20.5</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.0</ci_lower_limit>
            <ci_upper_limit>20.8</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>-9.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.4</ci_lower_limit>
            <ci_upper_limit>10.1</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Discontinuing Study Drug Due to AEs up to Week 144</title>
        <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
        <time_frame>Up to 144 weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinuing Study Drug Due to AEs up to Week 144</title>
          <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
          <population>All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</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="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.4</ci_lower_limit>
            <ci_upper_limit>14.5</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>-3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.4</ci_lower_limit>
            <ci_upper_limit>8.5</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.8</ci_lower_limit>
            <ci_upper_limit>18.1</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</title>
        <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
        <time_frame>Up to 24 weeks after 3TC and Placebo are discontinued from the regimen (up to approximately 60 weeks after initiating treatment)</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</title>
          <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
          <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2"/>
                    <measurement group_id="O2" value="90.0"/>
                    <measurement group_id="O3" value="88.9"/>
                    <measurement group_id="O4" value="96.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-9.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.1</ci_lower_limit>
            <ci_upper_limit>6.6</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-6.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.5</ci_lower_limit>
            <ci_upper_limit>9.1</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-7.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.9</ci_lower_limit>
            <ci_upper_limit>8.8</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen</title>
        <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
        <time_frame>Up to 48 weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen</title>
          <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
          <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.1"/>
                    <measurement group_id="O2" value="56.7"/>
                    <measurement group_id="O3" value="59.3"/>
                    <measurement group_id="O4" value="60.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.4</ci_lower_limit>
            <ci_upper_limit>27.7</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-3.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.6</ci_lower_limit>
            <ci_upper_limit>22.1</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in percent response</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or &gt;100,000 copies/mL).</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.7</ci_lower_limit>
            <ci_upper_limit>25.2</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)</title>
        <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA &lt;50 copies in Part 4 are reported.</description>
        <time_frame>Up to Week 192</time_frame>
        <population>Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>DOR/ISL Continued (Part 4)</title>
            <description>In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label in Part 3 and continued treatment through Week 192.</description>
          </group>
          <group group_id="O2">
            <title>DOR/ISL Switch (Part 4)</title>
            <description>In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt;50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)</title>
          <description>Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA &lt;50 copies in Part 4 are reported.</description>
          <population>Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data were analyzed.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.1"/>
                    <measurement group_id="O2" value="95.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24</title>
        <description>Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24</title>
          <description>Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
          <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="220.5" lower_limit="170.3" upper_limit="270.8"/>
                    <measurement group_id="O2" value="192.8" lower_limit="117.9" upper_limit="267.7"/>
                    <measurement group_id="O3" value="142.9" lower_limit="89.9" upper_limit="196.0"/>
                    <measurement group_id="O4" value="142.1" lower_limit="105.7" upper_limit="178.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>78.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.8</ci_lower_limit>
            <ci_upper_limit>138.1</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>50.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.7</ci_lower_limit>
            <ci_upper_limit>133.1</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-63.0</ci_lower_limit>
            <ci_upper_limit>64.7</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CD4+ T-cell Count at Week 48</title>
        <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
        <time_frame>Baseline and Week 48</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CD4+ T-cell Count at Week 48</title>
          <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
          <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182.0" lower_limit="119.6" upper_limit="244.5"/>
                    <measurement group_id="O2" value="183.0" lower_limit="124.7" upper_limit="241.2"/>
                    <measurement group_id="O3" value="100.7" lower_limit="25.0" upper_limit="176.3"/>
                    <measurement group_id="O4" value="181.4" lower_limit="137.2" upper_limit="225.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-74.1</ci_lower_limit>
            <ci_upper_limit>75.3</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-70.7</ci_lower_limit>
            <ci_upper_limit>73.8</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-80.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-165.6</ci_lower_limit>
            <ci_upper_limit>4.0</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CD4+ T-cell Count at Week 96</title>
        <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
        <time_frame>Baseline and Week 96</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CD4+ T-cell Count at Week 96</title>
          <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
          <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243.4" lower_limit="165.5" upper_limit="321.3"/>
                    <measurement group_id="O2" value="161.3" lower_limit="90.2" upper_limit="232.4"/>
                    <measurement group_id="O3" value="136.5" lower_limit="57.0" upper_limit="216.0"/>
                    <measurement group_id="O4" value="268.9" lower_limit="188.5" upper_limit="349.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-25.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-134.8</ci_lower_limit>
            <ci_upper_limit>83.8</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-107.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-212.1</ci_lower_limit>
            <ci_upper_limit>-3.1</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-132.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-242.9</ci_lower_limit>
            <ci_upper_limit>-21.9</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CD4+ T-cell Count at Week 144</title>
        <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
        <time_frame>Baseline and Week 144</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CD4+ T-cell Count at Week 144</title>
          <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.</description>
          <population>All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.</population>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204.4" lower_limit="102.0" upper_limit="306.7"/>
                    <measurement group_id="O2" value="209.0" lower_limit="111.5" upper_limit="306.6"/>
                    <measurement group_id="O3" value="162.9" lower_limit="70.2" upper_limit="255.5"/>
                    <measurement group_id="O4" value="270.0" lower_limit="183.2" upper_limit="356.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-65.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-195.3</ci_lower_limit>
            <ci_upper_limit>64.0</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-61.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-188.7</ci_lower_limit>
            <ci_upper_limit>66.8</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in T-cell count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The 95% CI for mean difference in CD4 change was based on t-distribution.</non_inferiority_desc>
            <param_type>Treatment Difference</param_type>
            <param_value>-107.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-231.2</ci_lower_limit>
            <ci_upper_limit>16.9</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)</title>
        <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported.</description>
        <time_frame>Baseline and Week 192</time_frame>
        <population>Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>DOR/ISL Continued (Part 4)</title>
            <description>In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label in Part 3 and continued treatment through Week 192.</description>
          </group>
          <group group_id="O2">
            <title>DOR/ISL Switch (Part 4)</title>
            <description>In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)</title>
          <description>Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported.</description>
          <population>Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data were analyzed.</population>
          <units>cells/mm^3</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="-1.9" upper_limit="9.5"/>
                    <measurement group_id="O2" value="-3.4" lower_limit="-12.0" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</title>
        <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</title>
          <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
          <population>All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</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="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>4.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.3</ci_lower_limit>
            <ci_upper_limit>29.6</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>9.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.4</ci_lower_limit>
            <ci_upper_limit>33.5</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>-5.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.6</ci_lower_limit>
            <ci_upper_limit>20.7</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</title>
        <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen</title>
          <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.</description>
          <population>All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</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="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>-3.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.9</ci_lower_limit>
            <ci_upper_limit>8.5</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>-3.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.9</ci_lower_limit>
            <ci_upper_limit>8.2</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Difference in % Islatravir vs DOR/3TC/TDF</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Based on Miettinen &amp; Nurminen method.</non_inferiority_desc>
            <param_type>Difference in %</param_type>
            <param_value>3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.5</ci_lower_limit>
            <ci_upper_limit>20.6</ci_upper_limit>
            <estimate_desc>Islatravir minus DOR/3TC/TDF</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing AEs From Week 96 Through Study Duration</title>
        <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
        <time_frame>Week 96 up to Week 192</time_frame>
        <population>Per protocol, all randomized participants who received at least 1 dose of open label study treatment in Part 3 or Part 4, corresponding to the study treatment they actually received were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144.</description>
          </group>
          <group group_id="O5">
            <title>DOR/ISL Continued</title>
            <description>In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.</description>
          </group>
          <group group_id="O6">
            <title>DOR/ISL Switch</title>
            <description>In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing AEs From Week 96 Through Study Duration</title>
          <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
          <population>Per protocol, all randomized participants who received at least 1 dose of open label study treatment in Part 3 or Part 4, corresponding to the study treatment they actually received were analyzed.</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="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="67"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="36"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration</title>
        <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
        <time_frame>Week 96 up to Week 192</time_frame>
        <population>Per protocol, all randomized participants who received at least 1 dose of open label study treatment in Part 3 or Part 4, corresponding to the study treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Islatravir 0.25 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
          </group>
          <group group_id="O2">
            <title>Islatravir 0.75 mg</title>
            <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
          </group>
          <group group_id="O3">
            <title>Islatravir 2.25 mg</title>
            <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
          </group>
          <group group_id="O4">
            <title>DOR/3TC/TDF</title>
            <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144.</description>
          </group>
          <group group_id="O5">
            <title>DOR/ISL Continued</title>
            <description>In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.</description>
          </group>
          <group group_id="O6">
            <title>DOR/ISL Switch</title>
            <description>In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration</title>
          <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.</description>
          <population>Per protocol, all randomized participants who received at least 1 dose of open label study treatment in Part 3 or Part 4, corresponding to the study treatment they actually received.</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="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="67"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)</title>
        <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced AEs during Part 4 are reported.</description>
        <time_frame>Week 144 up to Week 192</time_frame>
        <population>Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment, corresponding to the study treatment they actually received were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>DOR/ISL Continued (Part 4)</title>
            <description>In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.</description>
          </group>
          <group group_id="O2">
            <title>DOR/ISL Switch (Part 4)</title>
            <description>In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)</title>
          <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced AEs during Part 4 are reported.</description>
          <population>Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment, corresponding to the study treatment they actually received were analyzed.</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="67"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)</title>
        <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued the study drug due to AEs in Part 4 are reported.</description>
        <time_frame>Week 144 up to Week 192</time_frame>
        <population>Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment, corresponding to the study treatment they actually received were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>DOR/ISL Continued (Part 4)</title>
            <description>In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.</description>
          </group>
          <group group_id="O2">
            <title>DOR/ISL Switch (Part 4)</title>
            <description>In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)</title>
          <description>An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued the study drug due to AEs in Part 4 are reported.</description>
          <population>Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment, corresponding to the study treatment they actually received were analyzed.</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="67"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks.</time_frame>
      <desc>The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Islatravir 0.25mg</title>
          <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
        </group>
        <group group_id="E2">
          <title>Islatravir 0.75mg</title>
          <description>In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
        </group>
        <group group_id="E3">
          <title>Islatravir 2.25mg</title>
          <description>In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA &lt;50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.</description>
        </group>
        <group group_id="E4">
          <title>DOR/3TC/TDF</title>
          <description>In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144.</description>
        </group>
        <group group_id="E5">
          <title>DOR/ISL Continued</title>
          <description>In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.</description>
        </group>
        <group group_id="E6">
          <title>DOR/ISL Switch</title>
          <description>In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Long QT syndrome congenital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dysentery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Large intestine infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumonia chlamydial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Burkitt's lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25.0</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="22" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="21" subjects_at_risk="67"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="11" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal chlamydia infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="14" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oropharyngeal gonococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Proctitis chlamydial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Proctitis gonococcal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Syphilis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </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="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </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="2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </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="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Adjustment disorder with depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Penile ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </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>If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme LLC</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/NCT03272347
org study id: 8591-011
secondary id: 2017-000437-32
nct id: NCT03272347
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the safety, tolerability, antiretroviral activity, and
      pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and
      lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human
      immunodeficiency virus type 1 (HIV-1) infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Masking in Part 1, including matching placebo. Masking only to dose in Part 2. No masking in Parts 3 and 4.
measure: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24
time frame: Week 24
description: Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.
measure: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
time frame: Week 48
description: Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.
measure: Number of Participants Experiencing Adverse Events (AEs) up to Week 144
time frame: Up to 144 weeks
description: An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
measure: Number of Participants Discontinuing Study Drug Due to AEs up to Week 144
time frame: Up to 144 weeks
description: An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
measure: Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
time frame: Up to 24 weeks after 3TC and Placebo are discontinued from the regimen (up to approximately 60 weeks after initiating treatment)
description: Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.
measure: Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen
time frame: Up to 48 weeks
description: Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.
measure: Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)
time frame: Up to Week 192
description: Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA <50 copies in Part 4 are reported.
measure: Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24
time frame: Baseline and Week 24
description: Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.
measure: Change From Baseline in CD4+ T-cell Count at Week 48
time frame: Baseline and Week 48
description: Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.
measure: Change From Baseline in CD4+ T-cell Count at Week 96
time frame: Baseline and Week 96
description: Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.
measure: Change From Baseline in CD4+ T-cell Count at Week 144
time frame: Baseline and Week 144
description: Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.
measure: Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)
time frame: Baseline and Week 192
description: Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported.
measure: Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
time frame: Up to 24 weeks
description: An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.
measure: Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
time frame: Up to 24 weeks
description: An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.
measure: Number of Participants Experiencing AEs From Week 96 Through Study Duration
time frame: Week 96 up to Week 192
description: An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
measure: Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration
time frame: Week 96 up to Week 192
description: An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
measure: Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)
time frame: Week 144 up to Week 192
description: An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced AEs during Part 4 are reported.
measure: Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)
time frame: Week 144 up to Week 192
description: An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued the study drug due to AEs in Part 4 are reported.
arm group label: Islatravir 0.25 mg
arm group type: Experimental
description: Participants will be treated once daily (QD) with 0.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.
arm group label: Islatravir 0.75 mg
arm group type: Experimental
description: Participants will be treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and will continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.
arm group label: Islatravir 2.25 mg
arm group type: Experimental
description: Participants will be treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and will continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.
arm group label: DOR/3TC/TDF
arm group type: Active Comparator
description: Participants will be treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. Between week 24 through week 52 placebo treatments may be discontinued and participants will receive only DOR/3TC/TDF QD open label up to Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.
intervention type: Drug
intervention name: Islatravir
description: Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.
arm group label: Islatravir 0.25 mg
arm group label: Islatravir 0.75 mg
arm group label: Islatravir 2.25 mg
other name: MK-8591
intervention type: Drug
intervention name: Placebo to Islatravir
description: Placebo to islatravir is orally administered QD in capsule form for up to 52 weeks
arm group label: DOR/3TC/TDF
intervention type: Drug
intervention name: Doravirine
description: Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks
arm group label: Islatravir 0.25 mg
arm group label: Islatravir 0.75 mg
arm group label: Islatravir 2.25 mg
other name: MK-1439
intervention type: Drug
intervention name: Placebo to Doravirine
description: Placebo to Doravirine is orally administered QD in tablet form for up to 52 weeks
arm group label: DOR/3TC/TDF
intervention type: Drug
intervention name: Lamivudine
description: Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks
arm group label: Islatravir 0.25 mg
arm group label: Islatravir 0.75 mg
arm group label: Islatravir 2.25 mg
other name: 3TC
intervention type: Drug
intervention name: Placebo to Lamivudine
description: Placebo to Lamivudine is orally administered QD in tablet form for up to 52 weeks
arm group label: DOR/3TC/TDF
intervention type: Drug
intervention name: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
description: Fixed dose combination of 100 mg doravirine + 300 mg lamivudine + 300 mg tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 144 weeks.
arm group label: DOR/3TC/TDF
other name: MK-1439A
intervention type: Drug
intervention name: Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
description: Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks
arm group label: Islatravir 0.25 mg
arm group label: Islatravir 0.75 mg
arm group label: Islatravir 2.25 mg
intervention type: Drug
intervention name: Doravirine/Islatravir
description: Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks
arm group label: DOR/3TC/TDF
arm group label: Islatravir 0.25 mg
arm group label: Islatravir 0.75 mg
arm group label: Islatravir 2.25 mg
other name: MK-8591A
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
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country: Chile
country: France
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Tenofovir
mesh term: Lamivudine
mesh term: Islatravir
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
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