<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/NCT03227861</url>
  </required_header>
  <id_info>
    <org_study_id>CR108345</org_study_id>
    <secondary_id>TMC114FD2HTX3002</secondary_id>
    <nct_id>NCT03227861</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care</brief_title>
  <official_title>A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Receiving Care in a Test and Treat Model of Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Scientific Affairs, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Scientific Affairs, LLC</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/&#xD;
      Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of&#xD;
      care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive&#xD;
      participants as determined by the proportion of virologic responders defined as having&#xD;
      (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">September 4, 2019</completion_date>
  <primary_completion_date type="Actual">January 3, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (&lt;) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach</measure>
    <time_frame>Week 48</time_frame>
    <description>Percentage of participants with a HIV-1 RNA &lt; 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is &lt; 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in log10 HIV-1 RNA Viral Load (&lt;50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48</measure>
    <time_frame>Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48</time_frame>
    <description>Change from baseline in log10 HIV-1 RNA viral load (&lt;50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Percentage of participants with HIV-1 RNA &lt; 50 copies/mL were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48</measure>
    <time_frame>Baseline, Weeks 12, 24 and 48</time_frame>
    <description>The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula &lt; 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (&gt;=) 2.5*upper limit of normal (ULN); c). Serum lipase &gt;=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Grade 3 and 4 Adverse Events</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings</measure>
    <time_frame>Up to Day 35</time_frame>
    <description>Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)</measure>
    <time_frame>Baseline (Day 1)</time_frame>
    <description>Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [&lt;500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48</measure>
    <time_frame>Week 24 and 48</time_frame>
    <description>Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA &gt;= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (&gt;=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment Adherence &gt;95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48</measure>
    <time_frame>Weeks 4, 8, 12, 24, 36, and 48</time_frame>
    <description>Percentage of participants with treatment adherence &gt;95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (&gt;) 95 percent (%) by pill count.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48</measure>
    <time_frame>Weeks 4, 8, 12, 24, 36, and 48</time_frame>
    <description>Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hospitalizations</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Number of participants with hospitalizations (overnight) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospitalizations</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Outpatient Visits</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Emergency Room Visits</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Number of participants with emergency room visits was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96</measure>
    <time_frame>Up to Week 96</time_frame>
    <description>Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96</measure>
    <time_frame>Up to Week 96</time_frame>
    <description>AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96</measure>
    <time_frame>Up to Week 96</time_frame>
    <description>Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96</measure>
    <time_frame>Weeks 72 and 96</time_frame>
    <description>Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA &gt;= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>HIV-1</condition>
  <arm_group>
    <arm_group_label>DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC</intervention_name>
    <description>Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.</description>
    <arm_group_label>DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of&#xD;
             the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody&#xD;
             positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1&#xD;
             ribonucleic acid (RNA) viral load greater than or equal to (&gt;=) 5,000 copies per&#xD;
             milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1&#xD;
             RNA viral load (&gt;=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once&#xD;
             within 1 week of initial HIV-1 RNA viral load test&#xD;
&#xD;
          -  Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure&#xD;
             prophylaxis (PrEP)&#xD;
&#xD;
          -  Must be able to swallow whole tablets&#xD;
&#xD;
          -  A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted&#xD;
             reproduction during the study and for 90 days after receiving the last dose of study&#xD;
             drug&#xD;
&#xD;
          -  A woman of childbearing potential must have a negative urine pregnancy test at&#xD;
             screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium&#xD;
             tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining&#xD;
             condition that in the judgement of the investigator would increase the risk of&#xD;
             morbidity or mortality&#xD;
&#xD;
          -  Known history of clinically relevant hepatic disease or hepatitis that in the&#xD;
             investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/&#xD;
             Tenofovir Alafenamide (D/C/F/TAF FDC)&#xD;
&#xD;
          -  Known history of cirrhosis as diagnosed based on local practices&#xD;
&#xD;
          -  Known history of chronic ([&gt;=] 3 months) renal insufficiency, defined as having an&#xD;
             estimated glomerular filtration rate (eGFR) less than (&lt;) 50 milliliter per minute&#xD;
             (mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula&#xD;
&#xD;
          -  Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this&#xD;
             study or within 90 days after the last dose of study treatment&#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>Janssen Scientific Affairs, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Scientific Affairs, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spectrum Medical Group</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Office of Franco Felizarta, MD</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whitman Walker Health</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midway Immunology and Research Center</name>
      <address>
        <city>Fort Pierce</city>
        <state>Florida</state>
        <zip>34982</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Immunology Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chatham County Health Department</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ruth M. Rothstein CORE Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Michael's Medical Center - Infectious Disease</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest CARE Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest CARE Center</name>
      <address>
        <city>Santa Fe</city>
        <state>New Mexico</state>
        <zip>87505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Infectious Diseases Consultants</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Centers for Infectious Disease Associates</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therapeutic Concepts - Donald R Watkins Foundation</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon Crofoot, MD</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <results_first_submitted>December 19, 2019</results_first_submitted>
  <results_first_submitted_qc>December 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 7, 2020</results_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03227861/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03227861/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Out of 97 participants who completed the main study, 80 participants continued into the extension phase and were treated with Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>D/C/F/TAF</title>
          <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Main Study Period (Week 0 to Week 48)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Extension Period (Week 48 to Week 96)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80">17 participants were not willing to enter extension study and discontinued after main study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Transition to Commercial D/C/F/TAF</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transition to Other ARV Treatment</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>D/C/F/TAF</title>
          <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="109"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.5" spread="12.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (&lt;) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach</title>
        <description>Percentage of participants with a HIV-1 RNA &lt; 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is &lt; 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.</description>
        <time_frame>Week 48</time_frame>
        <population>The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (&lt;) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach</title>
          <description>Percentage of participants with a HIV-1 RNA &lt; 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is &lt; 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.</description>
          <population>The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.4" lower_limit="76.44" upper_limit="90.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in log10 HIV-1 RNA Viral Load (&lt;50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48</title>
        <description>Change from baseline in log10 HIV-1 RNA viral load (&lt;50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.</description>
        <time_frame>Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48</time_frame>
        <population>The ITT analysis set included all participants who were randomized and received at least one dose of study treatment in study. Here, n (number analyzed) signifies participants analyzed for this outcome measure (OM) at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in log10 HIV-1 RNA Viral Load (&lt;50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48</title>
          <description>Change from baseline in log10 HIV-1 RNA viral load (&lt;50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.</description>
          <population>The ITT analysis set included all participants who were randomized and received at least one dose of study treatment in study. Here, n (number analyzed) signifies participants analyzed for this outcome measure (OM) at specified timepoints.</population>
          <units>log10 HIV-1 RNA copies per mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.65" spread="0.056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="0.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.43" spread="0.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.78" spread="0.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.08" spread="0.096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.14" spread="0.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.14" spread="0.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL at Week 24</title>
        <description>Percentage of participants with HIV-1 RNA &lt; 50 copies/mL were reported.</description>
        <time_frame>Week 24</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL at Week 24</title>
          <description>Percentage of participants with HIV-1 RNA &lt; 50 copies/mL were reported.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.7" lower_limit="73.35" upper_limit="87.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48</title>
        <description>The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.</description>
        <time_frame>Baseline, Weeks 12, 24 and 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48</title>
          <description>The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.</population>
          <units>Cells per millimeter cube (cells/mm^3)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.56" spread="16.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182.11" spread="16.885"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222.60" spread="20.618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules</title>
        <description>Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula &lt; 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (&gt;=) 2.5*upper limit of normal (ULN); c). Serum lipase &gt;=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules</title>
          <description>Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula &lt; 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (&gt;=) 2.5*upper limit of normal (ULN); c). Serum lipase &gt;=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.</description>
          <population>The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)</title>
        <description>Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)</title>
          <description>Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
          <population>The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Grade 3 and 4 Adverse Events</title>
        <description>AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Grade 3 and 4 Adverse Events</title>
          <description>AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.</description>
          <population>The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities</title>
        <description>Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities</title>
          <description>Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.</description>
          <population>The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperbilirubinemia: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperbilirubinemia: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophosphatemia: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophosphatemia: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Lymphocytes Count: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Lymphocytes Count: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings</title>
        <description>Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.</description>
        <time_frame>Up to Day 35</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings</title>
          <description>Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)</title>
        <description>Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [&lt;500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility).</description>
        <time_frame>Baseline (Day 1)</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)</title>
          <description>Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [&lt;500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility).</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this endpoint.</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="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Primary PI RAM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary PI RAM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Darunavir RAM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emtricitabine RAM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NNRTI RAM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Primary INI RAM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary INI RAM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48</title>
        <description>Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA &gt;= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
        <time_frame>Week 24 and 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48</title>
          <description>Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA &gt;= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)</title>
        <description>Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (&gt;=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)</title>
          <description>Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (&gt;=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment</title>
        <description>Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment</title>
          <description>Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit</title>
        <description>Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The modified ITT analysis set included all participants who were randomized and received at least one dose of study treatment and are HIV-1 positive after enrollment. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. Here, n (number analyzed) signifies participants analyzed at specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit</title>
          <description>Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.</description>
          <population>The modified ITT analysis set included all participants who were randomized and received at least one dose of study treatment and are HIV-1 positive after enrollment. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. Here, n (number analyzed) signifies participants analyzed at specified categories.</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Retention in care: Completed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented Clinical Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment Adherence &gt;95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48</title>
        <description>Percentage of participants with treatment adherence &gt;95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (&gt;) 95 percent (%) by pill count.</description>
        <time_frame>Weeks 4, 8, 12, 24, 36, and 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment Adherence &gt;95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48</title>
          <description>Percentage of participants with treatment adherence &gt;95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (&gt;) 95 percent (%) by pill count.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;95% at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;95% at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;95% at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;95% at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;95% at Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;95% at Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48</title>
        <description>Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.</description>
        <time_frame>Weeks 4, 8, 12, 24, 36, and 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48</title>
          <description>Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.</population>
          <units>Percentage of participants</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.76" spread="2.440"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.50" spread="3.518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.02" spread="6.967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.04" spread="10.949"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.49" spread="3.535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.48" spread="3.571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48</title>
        <description>The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48</title>
          <description>The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.52" spread="0.472"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.87" spread="0.387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.88" spread="0.442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hospitalizations</title>
        <description>Number of participants with hospitalizations (overnight) was reported.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hospitalizations</title>
          <description>Number of participants with hospitalizations (overnight) was reported.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Hospitalizations</title>
        <description>Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Hospitalizations</title>
          <description>Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="1" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Outpatient Visits</title>
        <description>Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Outpatient Visits</title>
          <description>Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>General practitioner visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specialist visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nurse practitioner visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician assistant visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Home healthcare nurse visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Emergency Room Visits</title>
        <description>Number of participants with emergency room visits was reported.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Emergency Room Visits</title>
          <description>Number of participants with emergency room visits was reported.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.</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="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])</title>
        <description>Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies those participants who were evaluable for the specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Main Study</title>
            <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])</title>
          <description>Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.</description>
          <population>The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies those participants who were evaluable for the specified categories.</population>
          <units>USA dollars</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overnight hospitalization</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2035.0" lower_limit="2035" upper_limit="4070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hospital day care ward (without overnight)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="341.0" lower_limit="341" upper_limit="341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emergency room visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212.0" lower_limit="212" upper_limit="424"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General practitioner visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142.0" lower_limit="71" upper_limit="355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specialist visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.0" lower_limit="94" upper_limit="752"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nurse practitioner visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0" lower_limit="66" upper_limit="264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician assistant visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" lower_limit="47" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148.0" lower_limit="16" upper_limit="788"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96</title>
        <description>Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
        <time_frame>Up to Week 96</time_frame>
        <population>Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Extension Study</title>
            <description>Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96</title>
          <description>Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.</description>
          <population>Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.</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="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96</title>
        <description>AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.</description>
        <time_frame>Up to Week 96</time_frame>
        <population>Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Extension Study</title>
            <description>Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96</title>
          <description>AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.</description>
          <population>Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.</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="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96</title>
        <description>Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.</description>
        <time_frame>Up to Week 96</time_frame>
        <population>Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Extension Study</title>
            <description>Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96</title>
          <description>Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.</description>
          <population>Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase.</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="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Glucose: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophosphatemia: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophosphatemia: Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96</title>
        <description>Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA &gt;= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
        <time_frame>Weeks 72 and 96</time_frame>
        <population>Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. Here 'n' (number analyzed) signifies number of participants with observed virologic response at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>D/C/F/TAF: Extension Study</title>
            <description>Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96</title>
          <description>Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA &lt;1 log10 reduction from baseline, and HIV-1 RNA &gt;= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA &lt;50 copies/mL, a rebound in HIV 1 RNA to &gt;= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a &gt;1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.</description>
          <population>Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. Here 'n' (number analyzed) signifies number of participants with observed virologic response at specified timepoints.</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="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 72</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Main study: Up to 48 Weeks; Extension Study: Up to 96 Weeks</time_frame>
      <desc>The safety analysis was performed on the Intent-to-treat analysis set (ITT) analysis set during main study (Week 0-48) included all the participants who were randomized and received at least one dose of study treatment in the study and safety analysis set (SAS) was used for the analyses during the extension study (Week 48-96) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>D/C/F/TAF: Main Study</title>
          <description>Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48.</description>
        </group>
        <group group_id="E2">
          <title>D/C/F/TAF: Extension Study</title>
          <description>Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Non-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="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Muscle Rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Road Traffic Accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Psychotic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Non-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="92" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Motion Sickness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypogonadism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness Transient</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lacrimation Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Lower</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anogenital Dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anorectal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dental Caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Duodenogastric Reflux</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Food Poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lip Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Paraesthesia Oral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Influenza Like Illness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Gallbladder Polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatic Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatic Steatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Seasonal Allergy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abscess Limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Acute Hepatitis C</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anal Chlamydia Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anorectal Human Papilloma Virus Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cellulitis Staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chlamydial Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Conjunctivitis Viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Genitourinary Chlamydia Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gonorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatitis A</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Gonococcal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Otitis Media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Papilloma Viral Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pharyngeal Chlamydia Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pilonidal Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Proctitis Gonococcal</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Secondary Syphilis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Syphilis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tooth Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Viral Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anal Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Exposure to Communicable Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Human Bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Muscle Strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Post-Traumatic Neck Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Pressure Diastolic Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Body Temperature Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac Murmur</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal Loss of Weight</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Impaired Fasting Glucose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Increased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vitamin D Deficiency</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cervical Spinal Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Groin Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Stiffness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Plantar Fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Systemic Lupus Erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tenosynovitis Stenosans</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Trigger Finger</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adrenal Adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Seborrhoeic Keratosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Warts</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal Dreams</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Adjustment Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Adjustment Disorder with Depressed Mood</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Adjustment Disorder with Mixed Anxiety and Depressed Mood</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Alcoholic Hangover</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bipolar Disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Depressed Mood</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Drug Abuse</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Initial Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Major Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Panic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Psychotic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical Dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Erectile Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary Congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rhinitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinus Congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermal Cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis Allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Macule</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Night Sweats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pityriasis Rosea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash Macular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash Papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash Pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Seborrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin Hypopigmentation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Diastolic Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Essential Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Systolic Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </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>A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study limitations included the open-label, single-arm study design and the small sample size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior director medical leader</name_or_title>
      <organization>Janssen Scientific Affairs, LLC</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.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/NCT03227861
org study id: CR108345
secondary id: TMC114FD2HTX3002
nct id: NCT03227861
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/
      Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of
      care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive
      participants as determined by the proportion of virologic responders defined as having
      (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
time frame: Week 48
description: Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is < 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
measure: Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48
time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48
description: Change from baseline in log10 HIV-1 RNA viral load (<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
time frame: Week 24
description: Percentage of participants with HIV-1 RNA < 50 copies/mL were reported.
measure: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48
time frame: Baseline, Weeks 12, 24 and 48
description: The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.
measure: Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules
time frame: Up to Week 48
description: Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula < 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (>=) 2.5*upper limit of normal (ULN); c). Serum lipase >=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.
measure: Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)
time frame: Up to Week 48
description: Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
measure: Percentage of Participants Experiencing Grade 3 and 4 Adverse Events
time frame: Up to Week 48
description: AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
measure: Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities
time frame: Up to Week 48
description: Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
measure: Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings
time frame: Up to Day 35
description: Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.
measure: Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)
time frame: Baseline (Day 1)
description: Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [<500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility).
measure: Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48
time frame: Week 24 and 48
description: Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
measure: Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)
time frame: Up to Week 48
description: Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
measure: Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment
time frame: Up to Week 48
description: Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.
measure: Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit
time frame: Up to Week 48
description: Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.
measure: Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48
time frame: Weeks 4, 8, 12, 24, 36, and 48
description: Percentage of participants with treatment adherence >95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count.
measure: Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48
time frame: Weeks 4, 8, 12, 24, 36, and 48
description: Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.
measure: Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48
time frame: Weeks 4, 24, and 48
description: The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction.
measure: Number of Participants With Hospitalizations
time frame: Up to Week 48
description: Number of participants with hospitalizations (overnight) was reported.
measure: Duration of Hospitalizations
time frame: Up to Week 48
description: Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.
measure: Number of Participants With Outpatient Visits
time frame: Up to Week 48
description: Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.
measure: Number of Participants With Emergency Room Visits
time frame: Up to Week 48
description: Number of participants with emergency room visits was reported.
measure: Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])
time frame: Up to Week 48
description: Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.
measure: Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96
time frame: Up to Week 96
description: Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
measure: Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96
time frame: Up to Week 96
description: AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
measure: Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96
time frame: Up to Week 96
description: Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
measure: Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96
time frame: Weeks 72 and 96
description: Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
arm group label: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
arm group type: Experimental
description: Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit.
intervention type: Drug
intervention name: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
description: Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.
arm group label: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Scientific Affairs, LLC Clinical Trial
role: Study Director
affiliation: Janssen Scientific Affairs, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study limitations included the open-label, single-arm study design and the small sample size.
point of contact: 