<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/NCT01709084</url>
  </required_header>
  <id_info>
    <org_study_id>CR100875</org_study_id>
    <secondary_id>TMC278IFD3002</secondary_id>
    <nct_id>NCT01709084</nct_id>
  </id_info>
  <brief_title>A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment</brief_title>
  <acronym>SALIF</acronym>
  <official_title>A Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression &lt;400 Copies/mL of TDF/FTC/RPV Versus TDF/FTC/EFV in First-line Antiretroviral NNRTI-based Suppressed Patients. Switching At Low HIV-1 RNA Into Fixed Dose Combinations (SALIF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag International NV</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to&#xD;
      standard treatment) in terms of the percentage of patients who have plasma human&#xD;
      immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per&#xD;
      mL after 48 weeks of randomized treatment with tenofovir disoproxil&#xD;
      fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 48-week, multicenter (study conducted at multiple sites), multinational (conducted&#xD;
      at different countries), open-label (all people know the identity of the intervention),&#xD;
      randomized (the study medication is assigned by chance) study to assess whether tenofovir&#xD;
      disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) shows noninferior response rates&#xD;
      of human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) suppression less than&#xD;
      400 copies per mL, compared with TDF/FTC/efavirenz (TDF/FTC/EFV). The study consists of 3&#xD;
      phases including, the screening phase (of 6 weeks), treatment phase (of 48 weeks), and follow&#xD;
      up phase (of 30 to 35 days after the last dose of study medication). During the 48 weeks&#xD;
      treatment phase, patients currently with HIV-1 RNA suppression less than 50 copies per mL on&#xD;
      their first-line antiretroviral regimen, will be randomized in a 1:1 ratio, in 2 groups, ie,&#xD;
      Group 1 (treatment group) and Group 2 (control group). Both these groups will receive a fixed&#xD;
      dose combination (FDC) regimen (ie, FDC tablet: one tablet per day) of either TDF/FTC/RPV in&#xD;
      Group 1 or TDF/FTC/EFV in Group 2. Patients will return for study visits at Week 4, 12, 24,&#xD;
      36, and 48 during the treatment period, and then every 24 weeks thereafter during the&#xD;
      extended treatment period until the last patient has his or her Week 48 (or treatment&#xD;
      discontinuation) visit. Safety evaluations for adverse events, clinical laboratory (central&#xD;
      and local) tests, electrocardiogram, vital signs, and physical examination will be performed&#xD;
      throughout the study. The treatment duration for each patient will be expected to be between&#xD;
      48 and 108 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2013</start_date>
  <completion_date type="Actual">July 2, 2020</completion_date>
  <primary_completion_date type="Actual">October 22, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (&lt;) 400 Copies Per Milliliter (Copies/mL) at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Plasma HIV-1 RNA Levels &lt; 50 Copies/mL at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Percentage of Participants with plasma HIV-1 RNA &lt;50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (&gt;=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.</measure>
    <time_frame>Week 48</time_frame>
    <description>Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA &gt;=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression &lt;400 copies/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Plasma HIV-1 RNA Levels &gt;= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.</measure>
    <time_frame>Week 48</time_frame>
    <description>Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA &gt;=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression &lt;50 copies/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participant With Treatment Adherence Based on Tablet Count</measure>
    <time_frame>Up to 48 Weeks</time_frame>
    <description>In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of &gt;95% (97% and 98% in RPV and EFV treated treatment groups respectively).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">426</enrollment>
  <condition>Human Immunodeficiency Virus-type 1 Infection</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive fixed dose combination (FDC) tablet of tenofovir disoproxil fumarate/emtricitabine/rilpivirine with a meal, until Week 48.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive FDC tablet of tenofovir disoproxil fumarate/emtricitabine /efavirenz on an empty stomach at bedtime, until Week 48.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rilpivirine</intervention_name>
    <description>Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.</description>
    <arm_group_label>Group 1</arm_group_label>
    <other_name>EDURANT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Efavirenz</intervention_name>
    <description>Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir disoproxil fumarate</intervention_name>
    <description>Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Emtricitabine</intervention_name>
    <description>Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Documented human immunodeficiency virus-type 1 (HIV-1) infection Patients who have been&#xD;
        receiving first line highly active antiretroviral therapy (HAART) for at least 1 year&#xD;
        before the screening visit Patients who have been taking the same ARV combination for at&#xD;
        least 8 weeks before the screening visit and are expected to continue on this regimen&#xD;
        throughout the screening period.&#xD;
&#xD;
        Patients who prefer to change the current HAART regimen for reasons of simplification&#xD;
        and/or toxicity of nucleoside/nucleotide reverse transcriptase inhibitor (N[t]RTI) Plasma&#xD;
        HIV-1 RNA less than 50 copies per mL and CD4+ cell count higher than 200 per mm3 at the&#xD;
        screening visit Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than&#xD;
        or equal to 400 copies per mL) while on previous or current ART History of immunologic&#xD;
        failure (2 consecutive CD4+ cell counts during HAART treatment falling below the pre-HAART&#xD;
        level) History of any primary N[t]RTI or NNRTI mutations Has a previously documented HIV-2&#xD;
        infection Significantly decreased hepatic function or hepatic insufficiency or diagnosed&#xD;
        with acute clinical viral hepatitis Diagnosed with Mycobacterium tuberculosis infection&#xD;
        Severe laboratory abnormalities Creatinine clearance less than 50 mL per minute Addicted to&#xD;
        drug, including alcohol or recreational drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Douala</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yaounde</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Eldoret</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kangemi, Nairobi</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nairobi</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nyanza</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dakar</city>
        <country>Senegal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pikine</city>
        <country>Senegal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bloemfontein</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Soweto</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wentworth, Durban</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Westville, KwaZulu</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amphur Mueang Nonthaburi</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chiang Mai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Entebbe</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cameroon</country>
    <country>Kenya</country>
    <country>Senegal</country>
    <country>South Africa</country>
    <country>Thailand</country>
    <country>Uganda</country>
  </location_countries>
  <removed_countries>
    <country>Ghana</country>
  </removed_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>October 5, 2016</results_first_submitted>
  <results_first_submitted_qc>November 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 5, 2017</results_first_posted>
  <last_update_submitted>January 22, 2021</last_update_submitted>
  <last_update_submitted_qc>January 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human immunodeficiency virus-type 1 infection</keyword>
  <keyword>HIV-1</keyword>
  <keyword>Infectious diseases</keyword>
  <keyword>Ribonucleic acid</keyword>
  <keyword>RNA</keyword>
  <keyword>Tenofovir disoproxil fumarate</keyword>
  <keyword>Emtricitabine</keyword>
  <keyword>Rilpivirine</keyword>
  <keyword>Efavirenz</keyword>
  <keyword>Edurant</keyword>
  <keyword>TMC278</keyword>
  <keyword>R278474</keyword>
  <keyword>Fixed dose combination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
    <mesh_term>Efavirenz</mesh_term>
    <mesh_term>Rilpivirine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TDF/FTC/RPV</title>
          <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
        </group>
        <group group_id="P2">
          <title>TDF/FTC/EFV</title>
          <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="213"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="211"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
                <participants group_id="P2" count="198"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Reached a Virologic Endpoint</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TDF/FTC/RPV</title>
          <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
        </group>
        <group group_id="B2">
          <title>TDF/FTC/EFV</title>
          <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</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="213"/>
            <count group_id="B2" value="211"/>
            <count group_id="B3" value="424"/>
          </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="40.6" spread="8"/>
                    <measurement group_id="B2" value="40.6" spread="8.7"/>
                    <measurement group_id="B3" value="40.6" spread="8.34"/>
                  </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="137"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="271"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="153"/>
                  </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>CAMEROON</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>KENYA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SENEGAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOUTH AFRICA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>THAILAND</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UGANDA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (&lt;) 400 Copies Per Milliliter (Copies/mL) at Week 48</title>
        <description>Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.</description>
        <time_frame>Week 48</time_frame>
        <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>TDF/FTC/RPV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>TDF/FTC/EFV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (&lt;) 400 Copies Per Milliliter (Copies/mL) at Week 48</title>
          <description>Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.</description>
          <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.</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="213"/>
                <count group_id="O2" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.9" lower_limit="-6.44"/>
                    <measurement group_id="O2" value="96.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Plasma HIV-1 RNA Levels &lt; 50 Copies/mL at Week 48</title>
        <description>Percentage of Participants with plasma HIV-1 RNA &lt;50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.</description>
        <time_frame>Week 48</time_frame>
        <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>TDF/FTC/RPV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>TDF/FTC/EFV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Plasma HIV-1 RNA Levels &lt; 50 Copies/mL at Week 48</title>
          <description>Percentage of Participants with plasma HIV-1 RNA &lt;50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.</description>
          <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.</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="213"/>
                <count group_id="O2" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.9"/>
                    <measurement group_id="O2" value="96.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (&gt;=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.</title>
        <description>Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA &gt;=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression &lt;400 copies/mL.</description>
        <time_frame>Week 48</time_frame>
        <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>TDF/FTC/RPV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>TDF/FTC/EFV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (&gt;=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.</title>
          <description>Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA &gt;=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression &lt;400 copies/mL.</description>
          <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.</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="201"/>
                <count group_id="O2" value="205"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Plasma HIV-1 RNA Levels &gt;= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.</title>
        <description>Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA &gt;=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression &lt;50 copies/mL.</description>
        <time_frame>Week 48</time_frame>
        <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>TDF/FTC/RPV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>TDF/FTC/EFV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Plasma HIV-1 RNA Levels &gt;= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.</title>
          <description>Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA &gt;=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression &lt;50 copies/mL.</description>
          <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.</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="201"/>
                <count group_id="O2" value="205"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participant With Treatment Adherence Based on Tablet Count</title>
        <description>In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of &gt;95% (97% and 98% in RPV and EFV treated treatment groups respectively).</description>
        <time_frame>Up to 48 Weeks</time_frame>
        <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>TDF/FTC/RPV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>TDF/FTC/EFV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participant With Treatment Adherence Based on Tablet Count</title>
          <description>In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of &gt;95% (97% and 98% in RPV and EFV treated treatment groups respectively).</description>
          <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.</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="207"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.2" spread="1.981"/>
                    <measurement group_id="O2" value="97.6" spread="1.649"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations</title>
        <description>To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>TDF/FTC/RPV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
          </group>
          <group group_id="O2">
            <title>TDF/FTC/EFV</title>
            <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations</title>
          <description>To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.</description>
          <population>The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>TDF/FTC/RPV</title>
          <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.</description>
        </group>
        <group group_id="E2">
          <title>TDF/FTC/EFV</title>
          <description>Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 16.0</default_vocab>
        <default_assessment>Non-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="16" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="211"/>
              </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="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food Allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Neurocysticercosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Neurosyphilis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Cervix Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Uterine Leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
              </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="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adenomyosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Uterine Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="128" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="137" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Malaria</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase Increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Increased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="211"/>
              </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="17" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="211"/>
              </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="19" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>It was an open label switch study with a significant number of patients (55%) on the Efavirenz (EFV) arm who did not switch their Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) unlike in the Rilpivirine (RPV) arm where 100% switched.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Director, R&amp;D, Medical Departement</name_or_title>
      <organization>Janssen R&amp;D US</organization>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709084
org study id: CR100875
secondary id: TMC278IFD3002
nct id: NCT01709084
lead sponsor: 
has dmc: Yes
The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to
      standard treatment) in terms of the percentage of patients who have plasma human
      immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per
      mL after 48 weeks of randomized treatment with tenofovir disoproxil
      fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).
This is a 48-week, multicenter (study conducted at multiple sites), multinational (conducted
      at different countries), open-label (all people know the identity of the intervention),
      randomized (the study medication is assigned by chance) study to assess whether tenofovir
      disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) shows noninferior response rates
      of human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) suppression less than
      400 copies per mL, compared with TDF/FTC/efavirenz (TDF/FTC/EFV). The study consists of 3
      phases including, the screening phase (of 6 weeks), treatment phase (of 48 weeks), and follow
      up phase (of 30 to 35 days after the last dose of study medication). During the 48 weeks
      treatment phase, patients currently with HIV-1 RNA suppression less than 50 copies per mL on
      their first-line antiretroviral regimen, will be randomized in a 1:1 ratio, in 2 groups, ie,
      Group 1 (treatment group) and Group 2 (control group). Both these groups will receive a fixed
      dose combination (FDC) regimen (ie, FDC tablet: one tablet per day) of either TDF/FTC/RPV in
      Group 1 or TDF/FTC/EFV in Group 2. Patients will return for study visits at Week 4, 12, 24,
      36, and 48 during the treatment period, and then every 24 weeks thereafter during the
      extended treatment period until the last patient has his or her Week 48 (or treatment
      discontinuation) visit. Safety evaluations for adverse events, clinical laboratory (central
      and local) tests, electrocardiogram, vital signs, and physical examination will be performed
      throughout the study. The treatment duration for each patient will be expected to be between
      48 and 108 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48
time frame: Week 48
description: Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
measure: Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48
time frame: Week 48
description: Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
measure: Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
time frame: Week 48
description: Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL.
measure: Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
time frame: Week 48
description: Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL.
measure: Percentage of Participant With Treatment Adherence Based on Tablet Count
time frame: Up to 48 Weeks
description: In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively).
measure: Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations
time frame: Up to Week 48
description: To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.
arm group label: Group 1
arm group type: Experimental
description: Patients will receive fixed dose combination (FDC) tablet of tenofovir disoproxil fumarate/emtricitabine/rilpivirine with a meal, until Week 48.
arm group label: Group 2
arm group type: Active Comparator
description: Patients will receive FDC tablet of tenofovir disoproxil fumarate/emtricitabine /efavirenz on an empty stomach at bedtime, until Week 48.
intervention type: Drug
intervention name: Rilpivirine
description: Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.
arm group label: Group 1
other name: EDURANT
intervention type: Drug
intervention name: Efavirenz
description: Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.
arm group label: Group 2
intervention type: Drug
intervention name: Tenofovir disoproxil fumarate
description: Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.
arm group label: Group 1
arm group label: Group 2
intervention type: Drug
intervention name: Emtricitabine
description: Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen-Cilag International NV Clinical Trial
role: Study Director
affiliation: Janssen-Cilag International NV
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country: Cameroon
country: Kenya
country: Senegal
country: South Africa
country: Thailand
country: Uganda
country: Ghana
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Efavirenz
mesh term: Rilpivirine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: It was an open label switch study with a significant number of patients (55%) on the Efavirenz (EFV) arm who did not switch their Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) unlike in the Rilpivirine (RPV) arm where 100% switched.
point of contact: 