<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/NCT02212379</url>
  </required_header>
  <id_info>
    <org_study_id>2014-000828-24</org_study_id>
    <secondary_id>ANRS 163 ETRAL</secondary_id>
    <nct_id>NCT02212379</nct_id>
  </id_info>
  <brief_title>Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL</brief_title>
  <official_title>Dual Therapy Combining Raltegravir With Etravirine Maintains a High Level of Viral Suppression Over 96 Weeks in Long-term Experienced HIV-infected Individuals Over 45 Years on a PI-based Regimen: Results From the Phase II ANRS 163 ETRAL Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Janssen-Cilag Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ANRS, Emerging Infectious Diseases</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter, international, non randomized (single arm), open, phase II trial aims to&#xD;
      evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological&#xD;
      success in virologically suppressed HIV-1 infected patients, of at least 45 years of age,&#xD;
      switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The&#xD;
      primary endpoint was the proportion of participants with virological success at 48 weeks.&#xD;
      Virological success is defined as the absence of 2 consecutive plasma viral load &gt;50&#xD;
      copies/mL within 2 to 4 weeks apart. The study was designed to show an efficacy &gt;90%,&#xD;
      assuming a success rate &gt;95%, with a power of 80% and a 5%type-1 error. A total of 160&#xD;
      individuals was required to achieve the objective. The principal secondary endpoint is the&#xD;
      proportion of patients in therapeutic success up to week 48 and 96.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96</measure>
    <time_frame>at week48 and at week 96</time_frame>
    <description>Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) &gt; 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen.&#xD;
The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Therapeutic Success at Week 48 and Week 96</measure>
    <time_frame>weeks 48 and 96</time_frame>
    <description>Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) &gt; 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96</measure>
    <time_frame>weeks 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)</measure>
    <time_frame>weeks 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time of Virological Failure</measure>
    <time_frame>week 96</time_frame>
    <description>Time between the date of the study treatment initiation and the date of virological failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA &gt; 200 Copies/mL</measure>
    <time_frame>weeks 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure</measure>
    <time_frame>week 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load &gt; 50 Copies/mL</measure>
    <time_frame>week 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Total Cell-associated HIV-DNA</measure>
    <time_frame>from day 0 to week 48 and week 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio</measure>
    <time_frame>from day 0 to week 48 and week 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Adverse Events and Effects</measure>
    <time_frame>From day 0 to week 48 and week 96</time_frame>
    <description>Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)</measure>
    <time_frame>from day 0 to week 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the Calibrated 5-year Framingham Risk Score</measure>
    <time_frame>from day 0 to week 48 and at week 96</time_frame>
    <description>The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome.&#xD;
Median percent change expressed as median (interquartile range (IQR))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change of Renal Function</measure>
    <time_frame>from day 0 to week 96</time_frame>
    <description>Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)</measure>
    <time_frame>from day 0 to week 96</time_frame>
    <description>Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study: Bone Mineral Density</measure>
    <time_frame>from day 0, to week 48 and week 96</time_frame>
    <description>• Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients)&#xD;
Lumbar spine BMD, mg/cm2&#xD;
Total hip BMD, mg/cm2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48</measure>
    <time_frame>week 48</time_frame>
    <description>• Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory Parameters</measure>
    <time_frame>from day 0 to week 96</time_frame>
    <description>• Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96</measure>
    <time_frame>day 0 and weeks 48 and 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Compliant With Treatment Program.</measure>
    <time_frame>at week 0, week 48, and week 96</time_frame>
    <description>The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots</measure>
    <time_frame>from day 0, to week 48</time_frame>
    <description>We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples</measure>
    <time_frame>from day 0, to week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96</measure>
    <time_frame>from day 0, to week 96</time_frame>
    <description>Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.&#xD;
Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin.&#xD;
Ovarian reserve measure is AMH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status</measure>
    <time_frame>from day 0, to week 96</time_frame>
    <description>BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>HIV-1 Infection</condition>
  <arm_group>
    <arm_group_label>raltegravir and etravirine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>raltegravir and etravirine</intervention_name>
    <description>Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
    <arm_group_label>raltegravir and etravirine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented HIV-1 infection&#xD;
&#xD;
          -  Age ≥ 45 years&#xD;
&#xD;
          -  Naïve to integrase inhibitor and etravirine&#xD;
&#xD;
          -  At least 6 months of stable antiretroviral therapy (ART) including a boosted protease&#xD;
             inhibitor, whatever the number of combined drugs&#xD;
&#xD;
          -  HIV-RNA plasma VL ≤ 50 copies/mL during the last 24 months prior to screening visit&#xD;
             (Week-6/Week-4), documented by at least 4 time-points with no more than one blip in&#xD;
             HIV-RNA plasma viral load between 51 and 200 copies/mL&#xD;
&#xD;
          -  HIV-RNA plasma VL ≤ 50 copies/mL at screening visit (Week-6/Week-4)&#xD;
&#xD;
          -  A genotype is available (on amplified DNA at Week-6/Week-4 Visit and/or on RNA in the&#xD;
             medical history of the patient) and shows a virus sensitive to ETR OR no genotype is&#xD;
             available (amplification failure on DNA at Week-6/Week-4 Visit and no genotype in the&#xD;
             medical history of the patient), there are no virological failure on NNRTI in the&#xD;
             medical history&#xD;
&#xD;
          -  CD4+ lymphocytes &gt; 200 cells/mm3&#xD;
&#xD;
          -  Creatinine &lt; 2.5 x ULN&#xD;
&#xD;
          -  CPK (Creatine Phospho Kinase) &lt; 6 ULN (Upper Limit of Normal)&#xD;
&#xD;
          -  AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) &lt; 5 ULN&#xD;
&#xD;
          -  Hemoglobin &gt; 10 g/dL&#xD;
&#xD;
          -  Platelets &gt; 100 000/mm3&#xD;
&#xD;
          -  Negative urinary pregnancy test and use of efficient contraception for women of&#xD;
             childbearing potential&#xD;
&#xD;
          -  For French participants only: subject enrolled in or a beneficiary of a Social&#xD;
             Security programme (State Medical Aid or AME is not a Social Security programme),&#xD;
             article L1121-11 of the Public health code&#xD;
&#xD;
          -  Patients with a coverage from a social health&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous exposure to raltegravir or etravirine&#xD;
&#xD;
          -  Presence of any documented integrase inhibitor mutation on DNA genotype at&#xD;
             Week-6/Week-4 and/or on RNA in the medical history of the patient&#xD;
&#xD;
          -  Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac&#xD;
&#xD;
          -  HIV-2 infection&#xD;
&#xD;
          -  Active viral hepatitis C requiring a specific treatment during the 24 months of the&#xD;
             trial&#xD;
&#xD;
          -  Patient with a history of non-compliance or irregular follow-up&#xD;
&#xD;
          -  Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or antidiabetic&#xD;
             treatment within the last 3 months prior the screening visit (Week-6 /Week-4)&#xD;
&#xD;
          -  Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®),&#xD;
             Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® -&#xD;
             Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John's wort, Carbamazepine&#xD;
             (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra™), Triazolam&#xD;
             (Halcion®)&#xD;
&#xD;
          -  Concomitant treatment using interferon, interleukins or any other immunotherapy or&#xD;
             chemotherapy&#xD;
&#xD;
          -  Concomitant prophylactic or curative treatment for an opportunistic infection&#xD;
&#xD;
          -  All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly&#xD;
             interfere with trial protocol compliance, adherence and/or trial treatment tolerance&#xD;
&#xD;
          -  Subjects under judicial protection due to temporarily and slightly diminished mental&#xD;
             or physical faculties, or under legal guardianship&#xD;
&#xD;
          -  Subjects participating in another clinical trial evaluating different therapies and&#xD;
             including an exclusion period that is still in force during the screening phase&#xD;
&#xD;
          -  Pregnant women or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Katlama, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service des Maladies Infectieuses et Tropicales, Groupe Hospitalier Pitié-Salpêtrière, Paris, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jacques Reynes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Département des Maladies Infectieuses et Tropicales Hôpital Gui de Chauliac, CHU de Montpellier France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dominique Costagliola, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Inserm UMR S 1136 Université Pierre et Marie Curie Epidémiologie, stratégies thérapeutiques et virologie cliniques dans l'infection à VIH, Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jean Verdier</name>
      <address>
        <city>Bondy</city>
        <zip>93140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint André</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin Bicêtre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Sainte marguerite</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Gui de Chauliac</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de l'Archet</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitié-Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</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>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75908</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08000</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la santa Creu i San Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.anrs.fr/</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <results_first_submitted>April 20, 2020</results_first_submitted>
  <results_first_submitted_qc>January 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2021</results_first_posted>
  <last_update_submitted>March 31, 2021</last_update_submitted>
  <last_update_submitted_qc>March 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Raltegravir</keyword>
  <keyword>Etravirine</keyword>
  <keyword>aged, 45 and over</keyword>
  <keyword>Viral load</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Safety</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Raltegravir Potassium</mesh_term>
    <mesh_term>Etravirine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study protocol, Statistical Analysis</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02212379/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02212379/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Between January and November 2015, 219 patients from 20 sites were screened and 170 patients were enrolled in the study.</recruitment_details>
      <pre_assignment_details>Five patients did not initiate the trial treatment by their own decision, leaving 165 patients for the analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Raltegravir and Etravirine</title>
          <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>From Baseline to Week 48</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="165"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>From Week 48 to Week 96</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="156"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Raltegravir and Etravirine</title>
          <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="165"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" lower_limit="48" upper_limit="58"/>
                  </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="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                  </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>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sub-saharan Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Transmission group</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Men who have Sex with Men</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterosexual</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others/Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since HIV diagnosis</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.8" lower_limit="12.8" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CDC stage C</title>
          <description>number of patients with Prior AIDS event</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4 nadir cell count</title>
          <units>cells/mm^3</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="209" lower_limit="93" upper_limit="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatitis C co-infection</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antiretroviral treatment (ART) duration</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.9" lower_limit="11.1" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of suppressed HIV viremia (&lt;50 copies/ml),</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.9" lower_limit="3.4" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of last combined antiretroviral therapy (cART)</title>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" lower_limit="32" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antiretroviral treatment daily dosing</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>once daily</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>twice daily</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>cART at screening</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>2NRTIs + PI/r</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NNRTI + PI/r</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PI/r</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Cardiovascular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyslipidemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Active smoking</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Former smokers</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol use (&gt;2 glasses/day)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4 cell count at screening</title>
          <units>cells/mm^3</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="700" lower_limit="525" upper_limit="904"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD8 cell count at screening</title>
          <units>cells/mm^3</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="678" lower_limit="525" upper_limit="966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4/CD8 ratio at screening</title>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.94" lower_limit="0.67" upper_limit="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total cholesterol</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.4" lower_limit="4.6" upper_limit="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Non-HDL cholesterol</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.9" lower_limit="3.4" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LDL cholesterol</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.2" lower_limit="2.7" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HDL cholesterol</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.3" lower_limit="1.1" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.3" lower_limit="1.0" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides/HDL ratio</title>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.0" lower_limit="0.6" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycaemia</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.2" lower_limit="4.7" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated glomerular filtration rate (eGFR, CKD-EPI method)</title>
          <units>mL/min/1.73 m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93.9" lower_limit="79.2" upper_limit="103.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.3" lower_limit="22.5" upper_limit="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist circumference</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92" lower_limit="84" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hip circumference</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95" lower_limit="90" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist/Hip ratio</title>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.97" lower_limit="0.9" upper_limit="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Viruses with mutations that could potentially impact etravirine</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96</title>
        <description>Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) &gt; 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen.&#xD;
The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96</description>
        <time_frame>at week48 and at week 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96</title>
          <description>Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) &gt; 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen.&#xD;
The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96</description>
          <units>percentage of participant</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="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.4" lower_limit="95.6" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" lower_limit="95.0" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Therapeutic Success at Week 48 and Week 96</title>
        <description>Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) &gt; 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure</description>
        <time_frame>weeks 48 and 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Therapeutic Success at Week 48 and Week 96</title>
          <description>Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) &gt; 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure</description>
          <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="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.1" lower_limit="90.5" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7" lower_limit="87.5" upper_limit="95.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96</title>
        <time_frame>weeks 48 and 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96</title>
          <units>percentage of participant</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="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="1.7" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="2.9" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)</title>
        <time_frame>weeks 48 and 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)</title>
          <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="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.01" upper_limit="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time of Virological Failure</title>
        <description>Time between the date of the study treatment initiation and the date of virological failure</description>
        <time_frame>week 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time of Virological Failure</title>
          <description>Time between the date of the study treatment initiation and the date of virological failure</description>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="1" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA &gt; 200 Copies/mL</title>
        <time_frame>weeks 48 and 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA &gt; 200 Copies/mL</title>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.01" upper_limit="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure</title>
        <time_frame>week 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load &gt; 50 Copies/mL</title>
        <time_frame>week 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load &gt; 50 Copies/mL</title>
          <units>hazard ratio</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="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Age &gt;60 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="1.4" upper_limit="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=2 glasses/day alcohol consumption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" lower_limit="1.5" upper_limit="85.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of Total Cell-associated HIV-DNA</title>
        <time_frame>from day 0 to week 48 and week 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of Total Cell-associated HIV-DNA</title>
          <units>percentage of change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline to week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-29" upper_limit="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-37" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio</title>
        <time_frame>from day 0 to week 48 and week 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio</title>
          <units>percentage of change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD4: 0-48 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="-10.9" upper_limit="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8: 0-48 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-18.7" upper_limit="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4/CD8: 0-48 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="-5.7" upper_limit="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4: 0-96 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="-9.4" upper_limit="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD8: 0-96 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.2" lower_limit="-17.1" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD4/CD8: 0-96 week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" lower_limit="-2.6" upper_limit="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Adverse Events and Effects</title>
        <description>Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects.</description>
        <time_frame>From day 0 to week 48 and week 96</time_frame>
        <population>After week 48, only 156 participants remained on the study treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Adverse Events and Effects</title>
          <description>Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects.</description>
          <population>After week 48, only 156 participants remained on the study treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE: 0-48 week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or 4 AE: 0-48 week</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="165"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE : 48-96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or 4 AE: 48-96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)</title>
        <time_frame>from day 0 to week 96</time_frame>
        <population>the number analyzed in one or more rows differs from overall number analyzed due to the Non determined data</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)</title>
          <population>the number analyzed in one or more rows differs from overall number analyzed due to the Non determined data</population>
          <units>percentage of change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>fasting triglycerides</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.8" lower_limit="-40.2" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>total cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-16.3" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL-cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="-7.1" upper_limit="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL-cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" lower_limit="-19.2" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>fasting glycemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-7.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of the Calibrated 5-year Framingham Risk Score</title>
        <description>The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome.&#xD;
Median percent change expressed as median (interquartile range (IQR))</description>
        <time_frame>from day 0 to week 48 and at week 96</time_frame>
        <population>the number of analyzed participants differs from overall participants due to the Non determined data.</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of the Calibrated 5-year Framingham Risk Score</title>
          <description>The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome.&#xD;
Median percent change expressed as median (interquartile range (IQR))</description>
          <population>the number of analyzed participants differs from overall participants due to the Non determined data.</population>
          <units>Median percent change as median (IQR)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>from D0 to week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="-22.9" upper_limit="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>from D0 to week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" lower_limit="-21.3" upper_limit="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change of Renal Function</title>
        <description>Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula</description>
        <time_frame>from day 0 to week 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change of Renal Function</title>
          <description>Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula</description>
          <units>Median percent change, as median (IQR)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" lower_limit="-6.6" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)</title>
        <description>Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96</description>
        <time_frame>from day 0 to week 96</time_frame>
        <population>Five participants were not evaluated at week 96</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)</title>
          <description>Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96</description>
          <population>Five participants were not evaluated at week 96</population>
          <units>percentage of change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total fat mass, Kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="-1.0" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limb fat, Kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" lower_limit="0.7" upper_limit="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trunk fat, Kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="-1.9" upper_limit="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sub-study: Bone Mineral Density</title>
        <description>• Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients)&#xD;
Lumbar spine BMD, mg/cm2&#xD;
Total hip BMD, mg/cm2</description>
        <time_frame>from day 0, to week 48 and week 96</time_frame>
        <population>The number analyzed in one or more rows differs from overall number analyzed due to the missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Sub-study: Bone Mineral Density</title>
          <description>• Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients)&#xD;
Lumbar spine BMD, mg/cm2&#xD;
Total hip BMD, mg/cm2</description>
          <population>The number analyzed in one or more rows differs from overall number analyzed due to the missing data</population>
          <units>percentage of change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lumbar spine BMD from D0 to week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="-1.1" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumbar spine BMD at week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-2.9" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total hip BMD from D0 to week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="-0.9" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total hip BMD at week 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-0.8" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48</title>
        <description>• Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48</description>
        <time_frame>week 48</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48</title>
          <description>• Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inflammatory Parameters</title>
        <description>• Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots</description>
        <time_frame>from day 0 to week 96</time_frame>
        <population>The number analyzed in one or more rows differs from overall number analyzed due to the missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Inflammatory Parameters</title>
          <description>• Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots</description>
          <population>The number analyzed in one or more rows differs from overall number analyzed due to the missing data</population>
          <units>percentage of change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL-6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="-32.4" upper_limit="58.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IP-10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.1" lower_limit="-23.9" upper_limit="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sCD163</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="-21.0" upper_limit="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sCD14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27" lower_limit="-38" upper_limit="-8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-6.8" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hsCRP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-34.2" upper_limit="55.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D-Dimer</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5" lower_limit="-2.6" upper_limit="40.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insulin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="-16.0" upper_limit="42.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96</title>
        <time_frame>day 0 and weeks 48 and 96</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Compliant With Treatment Program.</title>
        <description>The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%).</description>
        <time_frame>at week 0, week 48, and week 96</time_frame>
        <population>Among 165 analyzed participated, 155 filled the baseline self-reported adherence questionnaire, 146 at week 48 and 136 at week 96</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Compliant With Treatment Program.</title>
          <description>The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%).</description>
          <population>Among 165 analyzed participated, 155 filled the baseline self-reported adherence questionnaire, 146 at week 48 and 136 at week 96</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>low (&lt;80) at W0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>medium (80-95) at W0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high (&gt;95) at W0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low (&lt;80) at W48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>medium (80-95) at W48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high (&gt;95) at W48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>low (&lt;80) at W96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>medium (80-95) at W96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>high (&gt;95) at W96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots</title>
        <description>We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48)</description>
        <time_frame>from day 0, to week 48</time_frame>
        <population>We evaluated the AMH level in 40 women with available samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots</title>
          <description>We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48)</description>
          <population>We evaluated the AMH level in 40 women with available samples.</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Reproductive activity: D0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.172" lower_limit="0.075" upper_limit="0.290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-menopausal: D0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009" lower_limit="0.008" upper_limit="0.012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-menopausal: D0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009" lower_limit="0.008" upper_limit="0.0095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reproductive activity: W48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.152" lower_limit="0.034" upper_limit="0.400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-menopausal: W48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.008" lower_limit="0.006" upper_limit="0.010"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-menopausal: W48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.005" lower_limit="0.004" upper_limit="0.007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples</title>
        <time_frame>from day 0, to week 48</time_frame>
        <population>We evaluated the MCP1 level in 40 women with available samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Raltegravir and Etravirine</title>
            <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
          </group>
        </group_list>
        <measure>
          <title>Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples</title>
          <population>We evaluated the MCP1 level in 40 women with available samples.</population>
          <units>Percentage change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Premenopausal with mesurable AMH</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="-18.9" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Premenopausal with reduced ovarian reserve</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="-2.1" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-menopausal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" lower_limit="-13.7" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96</title>
        <description>Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.&#xD;
Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin.&#xD;
Ovarian reserve measure is AMH</description>
        <time_frame>from day 0, to week 96</time_frame>
        <population>We evaluated the AMH level in 40 women with available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Premenopausal With Mesurable AMH</title>
            <description>AMH was detectable (level &gt;0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity</description>
          </group>
          <group group_id="O2">
            <title>Premenopausal With Reduced Ovarian Reserve</title>
            <description>AMH&lt;0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal</description>
          </group>
          <group group_id="O3">
            <title>Postmenopausal</title>
            <description>The menopausal status was recorded by the questionnaire at inclusion</description>
          </group>
        </group_list>
        <measure>
          <title>Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96</title>
          <description>Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.&#xD;
Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin.&#xD;
Ovarian reserve measure is AMH</description>
          <population>We evaluated the AMH level in 40 women with available samples</population>
          <units>Percentage of change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.62" lower_limit="-7.99" upper_limit="15.88"/>
                    <measurement group_id="O2" value="6.91" lower_limit="2.38" upper_limit="17.77"/>
                    <measurement group_id="O3" value="-11.35" lower_limit="-15.81" upper_limit="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL-cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.52" lower_limit="-20.13" upper_limit="27.13"/>
                    <measurement group_id="O2" value="5.62" lower_limit="-13.10" upper_limit="22.08"/>
                    <measurement group_id="O3" value="-6.58" lower_limit="-19.77" upper_limit="-0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL-cholesterol</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.47" lower_limit="3.90" upper_limit="27.79"/>
                    <measurement group_id="O2" value="27.74" lower_limit="16.77" upper_limit="42.86"/>
                    <measurement group_id="O3" value="-4.84" lower_limit="-11.35" upper_limit="9.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.59" lower_limit="-28.10" upper_limit="27.57"/>
                    <measurement group_id="O2" value="-38.37" lower_limit="-45.18" upper_limit="-13.70"/>
                    <measurement group_id="O3" value="-0.99" lower_limit="-33.12" upper_limit="16.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sCD14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.6" lower_limit="-39.2" upper_limit="-5.4"/>
                    <measurement group_id="O2" value="-32.8" lower_limit="-43.2" upper_limit="-23.4"/>
                    <measurement group_id="O3" value="-18.8" lower_limit="-36.5" upper_limit="-3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>sCD163</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" lower_limit="-9.7" upper_limit="32.3"/>
                    <measurement group_id="O2" value="15.9" lower_limit="-9.2" upper_limit="34.2"/>
                    <measurement group_id="O3" value="4.8" lower_limit="-21.0" upper_limit="49.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hsCRP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="-36.0" upper_limit="31.5"/>
                    <measurement group_id="O2" value="31.8" lower_limit="-63.3" upper_limit="122.6"/>
                    <measurement group_id="O3" value="-31.4" lower_limit="-44.7" upper_limit="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D-dimers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" lower_limit="-18.3" upper_limit="27.2"/>
                    <measurement group_id="O2" value="34.8" lower_limit="14.6" upper_limit="90.2"/>
                    <measurement group_id="O3" value="23.1" lower_limit="-7.9" upper_limit="46.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="-5.3" upper_limit="3.7"/>
                    <measurement group_id="O2" value="1.8" lower_limit="-9.9" upper_limit="4.2"/>
                    <measurement group_id="O3" value="-1.2" lower_limit="-7.8" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6hs</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" lower_limit="-21.6" upper_limit="62.7"/>
                    <measurement group_id="O2" value="-49.9" lower_limit="-50.5" upper_limit="-20.8"/>
                    <measurement group_id="O3" value="-0.9" lower_limit="-40.7" upper_limit="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IP-10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.3" lower_limit="-37.3" upper_limit="-2.9"/>
                    <measurement group_id="O2" value="8.2" lower_limit="-8.2" upper_limit="33.1"/>
                    <measurement group_id="O3" value="-5.4" lower_limit="-34.9" upper_limit="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insulin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.2" lower_limit="-48.6" upper_limit="-0.4"/>
                    <measurement group_id="O2" value="30.3" lower_limit="-7.9" upper_limit="50.0"/>
                    <measurement group_id="O3" value="11.4" lower_limit="-14.0" upper_limit="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status</title>
        <description>BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean</description>
        <time_frame>from day 0, to week 96</time_frame>
        <population>AMH level were evaluated in 40 women with available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Premenopausal With Mesurable AMH</title>
            <description>AMH was detectable (level &gt;0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity</description>
          </group>
          <group group_id="O2">
            <title>Premenopausal With Reduced Ovarian Reserve</title>
            <description>AMH&lt;0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal</description>
          </group>
          <group group_id="O3">
            <title>Postmenopausal</title>
            <description>The menopausal status was recorded by the questionnaire at inclusion</description>
          </group>
        </group_list>
        <measure>
          <title>Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status</title>
          <description>BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean</description>
          <population>AMH level were evaluated in 40 women with available samples</population>
          <units>Percentage of change</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Body mass index (BMI)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.96" lower_limit="-5.49" upper_limit="2.59"/>
                    <measurement group_id="O2" value="5.69" lower_limit="0.00" upper_limit="12.20"/>
                    <measurement group_id="O3" value="2.07" lower_limit="-1.10" upper_limit="5.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hip circumference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.06" lower_limit="-3.64" upper_limit="11.71"/>
                    <measurement group_id="O2" value="2.80" lower_limit="-1.16" upper_limit="8.85"/>
                    <measurement group_id="O3" value="3.09" lower_limit="-0.94" upper_limit="6.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Waist circumference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.74" lower_limit="-4.76" upper_limit="6.54"/>
                    <measurement group_id="O2" value="4.20" lower_limit="2.80" upper_limit="15.85"/>
                    <measurement group_id="O3" value="6.52" lower_limit="1.11" upper_limit="8.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Waist/hip ratio</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.43" lower_limit="-4.63" upper_limit="-1.17"/>
                    <measurement group_id="O2" value="0.02" lower_limit="-1.42" upper_limit="10.54"/>
                    <measurement group_id="O3" value="1.85" lower_limit="-1.17" upper_limit="5.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limb fat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.94" lower_limit="-5.84" upper_limit="1.94"/>
                    <measurement group_id="O2" value="6.74" lower_limit="-1.62" upper_limit="16.91"/>
                    <measurement group_id="O3" value="10.89" lower_limit="-0.03" upper_limit="28.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trunk fat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.90" lower_limit="-12.91" upper_limit="-2.27"/>
                    <measurement group_id="O2" value="18.80" lower_limit="10.32" upper_limit="25.31"/>
                    <measurement group_id="O3" value="21.27" lower_limit="5.96" upper_limit="39.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total fat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.59" lower_limit="-8.93" upper_limit="-2.13"/>
                    <measurement group_id="O2" value="16.77" lower_limit="7.35" upper_limit="17.91"/>
                    <measurement group_id="O3" value="24.39" lower_limit="0.61" upper_limit="31.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limb lean</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" lower_limit="-1.89" upper_limit="0.96"/>
                    <measurement group_id="O2" value="2.13" lower_limit="-2.73" upper_limit="6.21"/>
                    <measurement group_id="O3" value="-1.44" lower_limit="-2.91" upper_limit="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trunk lean</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.79" lower_limit="-4.60" upper_limit="2.54"/>
                    <measurement group_id="O2" value="5.53" lower_limit="1.93" upper_limit="20.75"/>
                    <measurement group_id="O3" value="-3.24" lower_limit="-6.20" upper_limit="-0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total lean</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.35" lower_limit="-1.93" upper_limit="1.14"/>
                    <measurement group_id="O2" value="5.83" lower_limit="2.02" upper_limit="8.12"/>
                    <measurement group_id="O3" value="-3.01" lower_limit="-4.14" upper_limit="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events data were collected from baseline to week 48 and 96</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Raltegravir and Etravirine</title>
          <description>raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.&#xD;
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Loss of teeth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Open wound of back</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic cytolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>AST increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Anal abcess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hospitalization further diagnosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Osteoarthrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Lumbago</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Pulmonary carcinomia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Delirious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Parotidectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Surgery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <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="23" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>dysgeusia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="165"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="165"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="165"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The absence of a comparator arm, which in terms of impact on fat, bone density and inflammation/activation markers may limit the interpretation of the observed changes over time. One limitation is the small number of women.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Lambert Assoumou</name_or_title>
      <organization>Inserm, Sorbonne Universite, IPLESP</organization>
      <phone>0142164280</phone>
      <email>lambert.assoumou@iplesp.upmc.fr</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/NCT02212379
org study id: 2014-000828-24
secondary id: ANRS 163 ETRAL
nct id: NCT02212379
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This multicenter, international, non randomized (single arm), open, phase II trial aims to
      evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological
      success in virologically suppressed HIV-1 infected patients, of at least 45 years of age,
      switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The
      primary endpoint was the proportion of participants with virological success at 48 weeks.
      Virological success is defined as the absence of 2 consecutive plasma viral load >50
      copies/mL within 2 to 4 weeks apart. The study was designed to show an efficacy >90%,
      assuming a success rate >95%, with a power of 80% and a 5%type-1 error. A total of 160
      individuals was required to achieve the objective. The principal secondary endpoint is the
      proportion of patients in therapeutic success up to week 48 and 96.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96
time frame: at week48 and at week 96
description: Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) > 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen.
The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96
measure: Percentage of Patients With Therapeutic Success at Week 48 and Week 96
time frame: weeks 48 and 96
description: Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) > 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure
measure: Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96
time frame: weeks 48 and 96
measure: Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)
time frame: weeks 48 and 96
measure: Median Time of Virological Failure
time frame: week 96
description: Time between the date of the study treatment initiation and the date of virological failure
measure: Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL
time frame: weeks 48 and 96
measure: Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure
time frame: week 96
measure: Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL
time frame: week 96
measure: Evolution of Total Cell-associated HIV-DNA
time frame: from day 0 to week 48 and week 96
measure: Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
time frame: from day 0 to week 48 and week 96
measure: Number of Participants Experiencing Adverse Events and Effects
time frame: From day 0 to week 48 and week 96
description: Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects.
measure: Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)
time frame: from day 0 to week 96
measure: Evolution of the Calibrated 5-year Framingham Risk Score
time frame: from day 0 to week 48 and at week 96
description: The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome.
Median percent change expressed as median (interquartile range (IQR))
measure: Percent Change of Renal Function
time frame: from day 0 to week 96
description: Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula
measure: Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)
time frame: from day 0 to week 96
description: Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96
measure: Sub-study: Bone Mineral Density
time frame: from day 0, to week 48 and week 96
description: • Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients)
Lumbar spine BMD, mg/cm2
Total hip BMD, mg/cm2
measure: Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48
time frame: week 48
description: • Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48
measure: Inflammatory Parameters
time frame: from day 0 to week 96
description: • Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots
measure: Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96
time frame: day 0 and weeks 48 and 96
measure: Percentage of Participants Compliant With Treatment Program.
time frame: at week 0, week 48, and week 96
description: The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%).
measure: Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
time frame: from day 0, to week 48
description: We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48)
measure: Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples
time frame: from day 0, to week 48
measure: Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
time frame: from day 0, to week 96
description: Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.
Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin.
Ovarian reserve measure is AMH
measure: Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
time frame: from day 0, to week 96
description: BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean
arm group label: raltegravir and etravirine
arm group type: Experimental
intervention type: Drug
intervention name: raltegravir and etravirine
description: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
arm group label: raltegravir and etravirine
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Christine Katlama, MD
role: Principal Investigator
affiliation: Service des Maladies Infectieuses et Tropicales, Groupe Hospitalier Pitié-Salpêtrière, Paris, France
last name: Jacques Reynes, MD
role: Study Chair
affiliation: Département des Maladies Infectieuses et Tropicales Hôpital Gui de Chauliac, CHU de Montpellier France
last name: Dominique Costagliola, PhD
role: Study Director
affiliation: Inserm UMR S 1136 Université Pierre et Marie Curie Epidémiologie, stratégies thérapeutiques et virologie cliniques dans l'infection à VIH, Paris, France
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country: France
country: Spain
url: http://www.anrs.fr/
description: Related Info
responsible party type: Sponsor
mesh term: Raltegravir Potassium
mesh term: Etravirine
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The absence of a comparator arm, which in terms of impact on fat, bone density and inflammation/activation markers may limit the interpretation of the observed changes over time. One limitation is the small number of women.
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