<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/NCT01705574</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-236-0128</org_study_id>
    <secondary_id>2012-003708-11</secondary_id>
    <nct_id>NCT01705574</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women</brief_title>
  <acronym>WAVES</acronym>
  <official_title>A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the efficacy of a regimen containing&#xD;
      elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus&#xD;
      ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate&#xD;
      (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2012</start_date>
  <completion_date type="Actual">September 6, 2018</completion_date>
  <primary_completion_date type="Actual">February 9, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm</measure>
    <time_frame>Week 48</time_frame>
    <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase</measure>
    <time_frame>Baseline; Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm</measure>
    <time_frame>Week 96</time_frame>
    <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA &lt; 50 Copies/mL at Week 48 of the Open-Label Extension Phase</measure>
    <time_frame>Open-Label Extension Week 48</time_frame>
    <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase</measure>
    <time_frame>Baseline; Open-Label Extension Week 48</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">583</enrollment>
  <condition>Acquired Immunodeficiency Syndrome</condition>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>E/C/F/TDF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATV + RTV+ FTC/TDF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ATV + RTV + FTC/TDF + E/C/F/TDF placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open-Label Extension Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 48 weeks of blinded treatment, participants will continue to take blinded study drug for 12 weeks and return for an unblinding visit at Week 60. Participants who are virologically suppressed at Week 48 during the double-blinded treatment phase will have the option to enter the open-label extension phase. Participants randomized to the E/C/F/TDF arm will continue to receive open-label E/C/F/TDF and participants randomized to the ATV+ RTV + FTC/TDF arm will be re-randomized to receive either open-label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or open-label ATV + RTV+ FTC/TDF.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E/C/F/TDF</intervention_name>
    <description>150/150/200/300 mg FDC tablet administered orally with food once daily</description>
    <arm_group_label>E/C/F/TDF</arm_group_label>
    <arm_group_label>Open-Label Extension Phase</arm_group_label>
    <other_name>Stribild®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATV</intervention_name>
    <description>300 mg capsule administered orally with food once daily</description>
    <arm_group_label>ATV + RTV+ FTC/TDF</arm_group_label>
    <arm_group_label>Open-Label Extension Phase</arm_group_label>
    <other_name>Reyataz®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RTV</intervention_name>
    <description>100 mg tablet administered orally with food once daily</description>
    <arm_group_label>ATV + RTV+ FTC/TDF</arm_group_label>
    <arm_group_label>Open-Label Extension Phase</arm_group_label>
    <other_name>Norvir®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FTC/TDF</intervention_name>
    <description>200/300 mg tablet administered orally with food once daily</description>
    <arm_group_label>ATV + RTV+ FTC/TDF</arm_group_label>
    <arm_group_label>Open-Label Extension Phase</arm_group_label>
    <other_name>Truvada®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E/C/F/TDF Placebo</intervention_name>
    <description>Tablet administered orally with food once daily</description>
    <arm_group_label>ATV + RTV+ FTC/TDF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATV Placebo</intervention_name>
    <description>Tablet administered orally with food once daily</description>
    <arm_group_label>E/C/F/TDF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RTV Placebo</intervention_name>
    <description>Capsule administered orally with food once daily</description>
    <arm_group_label>E/C/F/TDF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FTC/TDF Placebo</intervention_name>
    <description>Tablet administered orally with food once daily</description>
    <arm_group_label>E/C/F/TDF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E/C/F/TAF</intervention_name>
    <description>150/150/200/10 mg FDC tablet administered orally with food once daily</description>
    <arm_group_label>Open-Label Extension Phase</arm_group_label>
    <other_name>Genvoya®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Female (at birth), age ≥ 18 years&#xD;
&#xD;
          -  Ability to understand and sign a written informed consent form&#xD;
&#xD;
          -  Plasma HIV-1 RNA levels ≥ 500 copies/mL&#xD;
&#xD;
          -  No prior use of any approved or investigational antiretroviral drug for any length of&#xD;
             time&#xD;
&#xD;
          -  Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir&#xD;
             disoproxil fumarate (TDF) and atazanavir (ATV) boosted with ritonavir (RTV)&#xD;
&#xD;
          -  Normal ECG&#xD;
&#xD;
          -  Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to&#xD;
             the Cockcroft Gault formula&#xD;
&#xD;
          -  Hepatic transaminases ≤ 5 x upper limit of normal (ULN)&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5 mg/dL&#xD;
&#xD;
          -  Adequate hematologic function&#xD;
&#xD;
          -  Serum amylase ≤ 5 x ULN&#xD;
&#xD;
          -  Women of childbearing potential must agree to utilize protocol recommended&#xD;
             contraception methods or be non-heterosexually active, or practice sexual abstinence&#xD;
             from screening throughout the duration of the study period and for 30 days following&#xD;
             the last dose of study drug&#xD;
&#xD;
          -  Women who utilize hormonal contraceptive as one of their birth control methods must&#xD;
             have used the same method for at least three months prior to study dosing.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  A new AIDS defining condition diagnosed within the 30 days&#xD;
&#xD;
          -  Females receiving drug treatment for Hepatitis C, or females who are anticipated to&#xD;
             receive treatment for Hepatitis C during the course of the study&#xD;
&#xD;
          -  Females experiencing decompensated cirrhosis&#xD;
&#xD;
          -  Females who are breastfeeding&#xD;
&#xD;
          -  Positive serum pregnancy test (female of childbearing potential)&#xD;
&#xD;
          -  Have an implanted defibrillator or pacemaker&#xD;
&#xD;
          -  Have an ECG pulse rate interval ≥ 220 msec&#xD;
&#xD;
          -  Current alcohol or substance use which may potentially interfere with the female's&#xD;
             study compliance&#xD;
&#xD;
          -  History of malignancy within the past 5 years or ongoing malignancy other than&#xD;
             cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive&#xD;
             cutaneous squamous carcinoma&#xD;
&#xD;
          -  Active, serious infections requiring parenteral antibiotic or antifungal therapy&#xD;
             within 30 days prior to baseline&#xD;
&#xD;
          -  Participation in any other clinical trial without prior approval&#xD;
&#xD;
          -  Any other clinical condition or prior therapy that would make the female unsuitable&#xD;
             for the study or unable to comply with the dosing requirements&#xD;
&#xD;
          -  Females receiving ongoing therapy with any disallowed medications, including drugs not&#xD;
             to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any&#xD;
             known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir&#xD;
             capsules or ritonavir tablets&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California AIDS Clinical Trials Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</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>George Washington University Medical Faculty Associates</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</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>IDOCF/ValuhealthMD</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Hospital Comprehensive Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triple O Research Institute, P.A.</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Research Consortium of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory HIV/AIDS Clinical Trials Unit</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Disease Specialists of Atlanta</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercer University Mercer Medicine</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chatham County Health Daprtment</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSUHSC HIV Out-Patient Clinic Research</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Institute</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Michael's Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Medical School</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Hospital Queens</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>01135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina AIDS Clinical Trials Unit</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University The Brody School of Medicine Div. of Infectious Diseases</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wexner Medical Center at the Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Toledo Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia FIGHT</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital- Internal General Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Clinical Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT - Physicians</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AIDS Arms, Inc./Trinity Health &amp; Wellness Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Infectious Diseases Consultants, PA</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therapeutic Concepts, PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Tropical Medicine</name>
      <address>
        <city>Antwerp</city>
        <zip>2000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Pierre University Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux IRIS SUD</name>
      <address>
        <city>Brussels</city>
        <zip>1050</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Dominicano de Estudio Virologicos - IDEV</name>
      <address>
        <city>Santo Domingo</city>
        <zip>10514</zip>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salvador B Gautier Hospital, Infectious Diseases Department</name>
      <address>
        <city>Santo Domingo</city>
        <zip>10514</zip>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maladies Infectieuses Dpt</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Health Sciences - University of Milan - San Paolo Hospital</name>
      <address>
        <city>Milan</city>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luigi Sacco Hospital, Milan</name>
      <address>
        <city>Milan</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Malattie Infettive, Azienda Ospedaliero Universitaria</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Civil de Guadalajara Dr Juan I Menchaca</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44340</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Civil de Guadalajara</name>
      <address>
        <city>Guadalajara</city>
        <zip>44280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán</name>
      <address>
        <city>Mexico City</city>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Fernando Fonseca</name>
      <address>
        <city>Amadora</city>
        <zip>2720-276</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central</name>
      <address>
        <city>Lisboa</city>
        <zip>1200-110</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Maria - Serviço de Doenças Infecciosas</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>centro Hospitalar S. João</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto - Hospital Joaquim Urbano</name>
      <address>
        <city>Porto</city>
        <zip>4369-004</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Santarém</name>
      <address>
        <city>Santarem</city>
        <zip>2005-177</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maternal Infants Studies Center (CEMI)</name>
      <address>
        <city>San Juan</city>
        <zip>00936</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases</name>
      <address>
        <city>Barnaul</city>
        <zip>656010</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GUZ &quot;Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases</name>
      <address>
        <city>Irkutsk</city>
        <zip>664043</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases</name>
      <address>
        <city>Khabarovsk</city>
        <zip>680031</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Infectious Diseases Center&quot;, LLC</name>
      <address>
        <city>Koltsovo</city>
        <zip>630559</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Healthcare Institution &quot;Clinical Centre for AIDS and Infectious Diseases Fight and Prevention&quot; of Krasnodar regio Department for Healthcare</name>
      <address>
        <city>Krasnodar</city>
        <zip>350015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GUZ &quot;Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases&quot;</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GUZ &quot;Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases&quot;</name>
      <address>
        <city>Lipetsk</city>
        <zip>398043</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Hospital 2</name>
      <address>
        <city>Moscow</city>
        <zip>105275</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department</name>
      <address>
        <city>Moscow</city>
        <zip>105275</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GKUZ MO &quot;Center for Prevention and Treatment of AIDS and Infectious Diseases&quot; (Moscow Regional AIDS Center)</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Health Institution of Nizhniy Novgorod &quot;Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <zip>603950</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budgetary Medical Facility of the Orel Region &quot;Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases&quot;</name>
      <address>
        <city>Orel</city>
        <zip>302040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases</name>
      <address>
        <city>Perm</city>
        <zip>614000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>190020</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Petersburg GUZ &quot;Center for Prevention and Control of AIDS and Infectious Diseases&quot;, Out-patient Department</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>190103</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg GUZ &quot;Clinical Infectious Hospital named after S.P.Botkin&quot;</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>191167</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;Republic Clinical Infectious Hospital&quot;</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>196645</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases</name>
      <address>
        <city>Saratov</city>
        <zip>410009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases</name>
      <address>
        <city>Volgograd</city>
        <zip>400040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GUZ &quot;Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases&quot;</name>
      <address>
        <city>Voronezh</city>
        <zip>394065</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty of Medicine Ramathibodi Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiang Mai University</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bamrasnaradura lnfectious Disease Institute</name>
      <address>
        <city>Nonthaburi</city>
        <zip>11000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joint Clinical Research Centre</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Healthe NHS Trust</name>
      <address>
        <city>London</city>
        <zip>E11BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homerton University Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>E96SR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW32QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital, South London Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SE18 4QH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College London</name>
      <address>
        <city>London</city>
        <zip>SE59RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W21NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mortimer Market Centre and Central and North West London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>WC1E 6JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <zip>RG1 5LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Dominican Republic</country>
    <country>France</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Thailand</country>
    <country>Uganda</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
  </removed_countries>
  <results_reference>
    <citation>Squires K, Kityo C, Hodder S, Johnson M, Voronin E, Hagins D, Avihingsanon A, Koenig E, Jiang S, White K, Cheng A, Szwarcberg J, Cao H. Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study. Lancet HIV. 2016 Sep;3(9):e410-e420. doi: 10.1016/S2352-3018(16)30016-9. Epub 2016 May 27.</citation>
    <PMID>27562742</PMID>
  </results_reference>
  <results_reference>
    <citation>Hodder S, Squires K, Gathe J, Kityo C, Supparatpinyo K, Moshkovich G, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Presented at Interscience Conference on Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection (ICAAC/ICC) 2015; September 17-21; San Diego, CA.</citation>
  </results_reference>
  <results_reference>
    <citation>Squires K, Kityo C, Hodder S, Hagins D, Avihingsanon A, Plotnikova Y, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Poster no. MOLBPE08. Presented at 8th International Antiviral Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, 2015; 19-22 July, Vancouver, BC, Canada.</citation>
  </results_reference>
  <results_reference>
    <citation>Hodder S, Kityo C, Koenig E, Mussini C, Post F, Romanova S, et al. Genotypic analysis of the global clinical trial of treatment-naive women. Abstract 16. Presented at 5th International Workshop on HIV &amp; Women, 2015; 21-22 February, Seattle, WA.</citation>
  </results_reference>
  <results_reference>
    <citation>Squires K, Hodder S, Kityo C, Clumeck N, Johnson M, Plotnikova Y, et al. Enrollment in the Women's Antiretroviral Efficacy and Safety study (WAVES), a Phase 3 global study assessing antiretroviral regimen in treatment-naive women. Abstract 54. Presented at 5th International Workshop on HIV &amp; Women, 2015; 21-22 February, Seattle, WA.</citation>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>February 11, 2016</results_first_submitted>
  <results_first_submitted_qc>February 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 10, 2016</results_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV-1</keyword>
  <keyword>HIV</keyword>
  <keyword>Treatment-Naive</keyword>
  <keyword>Women</keyword>
  <keyword>WAVES</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in North America, Europe, Dominican Republic, Thailand, and Uganda. The first participant was screened on 24 October 2012. The last study visit occurred on 06 September 2018.</recruitment_details>
      <pre_assignment_details>810 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Double-Blind STB to Open-Label STB</title>
          <description>Double-Blind (DB) Phase: Stribild® (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) 150/150/200/300 mg fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + Truvada® (TVD; emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) placebo orally once daily with food for 48 weeks&#xD;
Open-Label Extension (OLE) Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Double-Blind ATV+RTV+TVD</title>
          <description>Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks</description>
        </group>
        <group group_id="P3">
          <title>Double-Blind ATV+RTV+TVD to Open-Label GEN</title>
          <description>Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks&#xD;
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label (OL) Genvoya® (GEN; elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; E/C/F/TAF) 150/150/200/10 mg FDC orally once daily with food for 48 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD</title>
          <description>Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks&#xD;
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-Blind Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="293"/>
                <participants group_id="P2" count="290"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="260"/>
                <participants group_id="P2" count="249"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </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="12"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-Label Extension Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="246"/>
                <participants group_id="P2" count="0">Participants either entered the OL GEN arm or OL ATV+RTV+TVD arm.</participants>
                <participants group_id="P3" count="159">159 participants entered from the DB ATV+RTV+TVD arm.</participants>
                <participants group_id="P4" count="53">53 participants entered from the DB ATV+ RTV + TVD arm.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="231"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="148"/>
                <participants group_id="P4" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="5"/>
              </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="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set included participants who were randomized and received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Double-Blind STB to Open-Label STB</title>
          <description>Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks&#xD;
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Double-Blind ATV+RTV+TVD to OL GEN or OL ATV+ RTV+TVD</title>
          <description>Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks&#xD;
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and either receive open-label GEN 150/150/200/10 mg FDC or open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="289"/>
            <count group_id="B2" value="286"/>
            <count group_id="B3" value="575"/>
          </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="36" spread="10.1"/>
                    <measurement group_id="B2" value="36" spread="9.7"/>
                    <measurement group_id="B3" value="36" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="289"/>
                    <measurement group_id="B2" value="286"/>
                    <measurement group_id="B3" value="575"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="276"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="247"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Permitted</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="269"/>
                    <measurement group_id="B2" value="262"/>
                    <measurement group_id="B3" value="531"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Permitted</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dominican Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uganda</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4 Cell Count</title>
          <units>cells/µL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="376" spread="199.6"/>
                    <measurement group_id="B2" value="385" spread="210.2"/>
                    <measurement group_id="B3" value="381" spread="204.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV-1 RNA Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>≤ 100,000 copies/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="220"/>
                    <measurement group_id="B2" value="214"/>
                    <measurement group_id="B3" value="434"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 100,000 to ≤400,000 copies/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 400,000 copies/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm</title>
        <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
        <time_frame>Week 48</time_frame>
        <population>Participants in the Intent-to-Treat (ITT) Analysis Set (randomized and received at least one dose of study drug) were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind STB</title>
            <description>Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind ATV+RTV+TVD</title>
            <description>Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + TVD (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm</title>
          <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
          <population>Participants in the Intent-to-Treat (ITT) Analysis Set (randomized and received at least one dose of study drug) were analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="289"/>
                <count group_id="O2" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2"/>
                    <measurement group_id="O2" value="80.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA &lt; 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group.</non_inferiority_desc>
            <param_type>Difference in proportions</param_type>
            <param_value>6.5</param_value>
            <ci_percent>95.2</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>12.6</ci_upper_limit>
            <estimate_desc>Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>If noninferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.034</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.</method_desc>
            <param_type>Difference in proportions</param_type>
            <param_value>6.5</param_value>
            <ci_percent>95.2</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>12.6</ci_upper_limit>
            <estimate_desc>Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was &gt; 0, superiority of STB over ATV+RTV+TVD was established.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase</title>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Participants in the ITT Analysis Set with available data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Double-Blind STB</title>
            <description>Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks</description>
          </group>
          <group group_id="O2">
            <title>Double-Blind ATV+RTV+TVD</title>
            <description>Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase</title>
          <population>Participants in the ITT Analysis Set with available data were analyzed.</population>
          <units>cells/μL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="263"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="221" spread="165.1"/>
                    <measurement group_id="O2" value="212" spread="176.8"/>
                  </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 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm</title>
        <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the ITT Analysis Set who received STB through 96 weeks were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>ALL STB</title>
            <description>Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks&#xD;
Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had option to receive open-label STB FDC orally once daily with food for 48 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA &lt; 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm</title>
          <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
          <population>Participants in the ITT Analysis Set who received STB through 96 weeks were analyzed.</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="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.5" lower_limit="79.7" upper_limit="88.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA &lt; 50 Copies/mL at Week 48 of the Open-Label Extension Phase</title>
        <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
        <time_frame>Open-Label Extension Week 48</time_frame>
        <population>Participants in the OLE ITT Analysis Set were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Open-Label GEN</title>
            <description>Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Open-Label ATV+RTV+TVD</title>
            <description>Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA &lt; 50 Copies/mL at Week 48 of the Open-Label Extension Phase</title>
          <description>The percentage of participants with HIV-1 RNA &lt; 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.</description>
          <population>Participants in the OLE ITT Analysis Set were analyzed.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.3"/>
                    <measurement group_id="O2" value="86.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase</title>
        <time_frame>Baseline; Open-Label Extension Week 48</time_frame>
        <population>Participants in the OLE ITT Analysis Set with available on-treatment data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Open-Label STB</title>
            <description>Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Open-Label GEN</title>
            <description>Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Open-Label ATV + RTV + TVD</title>
            <description>Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase</title>
          <population>Participants in the OLE ITT Analysis Set with available on-treatment data were analyzed.</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="239"/>
                <count group_id="O2" value="151"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="265" spread="190.4"/>
                    <measurement group_id="O2" value="35" spread="137.5"/>
                    <measurement group_id="O3" value="49" spread="204.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB (DB STB and OL STB) = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)</time_frame>
      <desc>Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.</desc>
      <group_list>
        <group group_id="E1">
          <title>Double-Blind: STB</title>
          <description>Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks</description>
        </group>
        <group group_id="E2">
          <title>Double-Blind: ATV+RTV+TVD</title>
          <description>Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks</description>
        </group>
        <group group_id="E3">
          <title>DB STB to OL STB</title>
          <description>Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.</description>
        </group>
        <group group_id="E4">
          <title>DB ATV+RTV+TVD to OL GEN</title>
          <description>Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.</description>
        </group>
        <group group_id="E5">
          <title>DB ATV+RTV+TVD to OL ATV+RTV+TVD</title>
          <description>Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and recieve open-label ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC orally once daily with food for 48 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="53"/>
              </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="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cardiomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Chronic hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Bone tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Breast abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Malaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Syphilis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram T wave inversion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </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="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Fibroadenoma of breast</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gestational hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Imminent abortion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ruptured ectopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine hypertonus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Conversion disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Substance abuse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </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="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </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="2" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Neonatal respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="176" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="194" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="118" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="68" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="20" subjects_at_risk="53"/>
              </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="11" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ocular icterus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Malaria</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </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="10" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="53"/>
              </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="20" subjects_at_risk="289"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="286"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="246"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="159"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="53"/>
              </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>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>There were no limitations affecting the analysis or results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Gilead Clinical Study Information Center</name_or_title>
      <organization>Gilead Sciences</organization>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@gilead.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/NCT01705574
org study id: GS-US-236-0128
secondary id: 2012-003708-11
nct id: NCT01705574
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to evaluate the efficacy of a regimen containing
      elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus
      ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate
      (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm
time frame: Week 48
description: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
measure: Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
time frame: Baseline; Week 48
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm
time frame: Week 96
description: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
measure: Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase
time frame: Open-Label Extension Week 48
description: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
measure: Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase
time frame: Baseline; Open-Label Extension Week 48
arm group label: E/C/F/TDF
arm group type: Experimental
description: E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo
arm group label: ATV + RTV+ FTC/TDF
arm group type: Active Comparator
description: ATV + RTV + FTC/TDF + E/C/F/TDF placebo
arm group label: Open-Label Extension Phase
arm group type: Experimental
description: After 48 weeks of blinded treatment, participants will continue to take blinded study drug for 12 weeks and return for an unblinding visit at Week 60. Participants who are virologically suppressed at Week 48 during the double-blinded treatment phase will have the option to enter the open-label extension phase. Participants randomized to the E/C/F/TDF arm will continue to receive open-label E/C/F/TDF and participants randomized to the ATV+ RTV + FTC/TDF arm will be re-randomized to receive either open-label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or open-label ATV + RTV+ FTC/TDF.
intervention type: Drug
intervention name: E/C/F/TDF
description: 150/150/200/300 mg FDC tablet administered orally with food once daily
arm group label: E/C/F/TDF
arm group label: Open-Label Extension Phase
other name: Stribild®
intervention type: Drug
intervention name: ATV
description: 300 mg capsule administered orally with food once daily
arm group label: ATV + RTV+ FTC/TDF
arm group label: Open-Label Extension Phase
other name: Reyataz®
intervention type: Drug
intervention name: RTV
description: 100 mg tablet administered orally with food once daily
arm group label: ATV + RTV+ FTC/TDF
arm group label: Open-Label Extension Phase
other name: Norvir®
intervention type: Drug
intervention name: FTC/TDF
description: 200/300 mg tablet administered orally with food once daily
arm group label: ATV + RTV+ FTC/TDF
arm group label: Open-Label Extension Phase
other name: Truvada®
intervention type: Drug
intervention name: E/C/F/TDF Placebo
description: Tablet administered orally with food once daily
arm group label: ATV + RTV+ FTC/TDF
intervention type: Drug
intervention name: ATV Placebo
description: Tablet administered orally with food once daily
arm group label: E/C/F/TDF
intervention type: Drug
intervention name: RTV Placebo
description: Capsule administered orally with food once daily
arm group label: E/C/F/TDF
intervention type: Drug
intervention name: FTC/TDF Placebo
description: Tablet administered orally with food once daily
arm group label: E/C/F/TDF
intervention type: Drug
intervention name: E/C/F/TAF
description: 150/150/200/10 mg FDC tablet administered orally with food once daily
arm group label: Open-Label Extension Phase
other name: Genvoya®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: United States
country: Brazil
citation: Squires K, Kityo C, Hodder S, Johnson M, Voronin E, Hagins D, Avihingsanon A, Koenig E, Jiang S, White K, Cheng A, Szwarcberg J, Cao H. Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study. Lancet HIV. 2016 Sep;3(9):e410-e420. doi: 10.1016/S2352-3018(16)30016-9. Epub 2016 May 27.
PMID: 27562742
citation: Hodder S, Squires K, Gathe J, Kityo C, Supparatpinyo K, Moshkovich G, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Presented at Interscience Conference on Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection (ICAAC/ICC) 2015; September 17-21; San Diego, CA.
citation: Squires K, Kityo C, Hodder S, Hagins D, Avihingsanon A, Plotnikova Y, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Poster no. MOLBPE08. Presented at 8th International Antiviral Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, 2015; 19-22 July, Vancouver, BC, Canada.
citation: Hodder S, Kityo C, Koenig E, Mussini C, Post F, Romanova S, et al. Genotypic analysis of the global clinical trial of treatment-naive women. Abstract 16. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.
citation: Squires K, Hodder S, Kityo C, Clumeck N, Johnson M, Plotnikova Y, et al. Enrollment in the Women's Antiretroviral Efficacy and Safety study (WAVES), a Phase 3 global study assessing antiretroviral regimen in treatment-naive women. Abstract 54. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Immunologic Deficiency Syndromes
mesh term: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There were no limitations affecting the analysis or results.
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