<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/NCT02987530</url>
  </required_header>
  <id_info>
    <org_study_id>ANRS 169</org_study_id>
    <secondary_id>2016-001683-11</secondary_id>
    <nct_id>NCT02987530</nct_id>
  </id_info>
  <brief_title>National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection</brief_title>
  <acronym>OPTIPRIM-2</acronym>
  <official_title>Phase III Multicenter Randomized Trial Evaluating in Patients at the Time of the Primary HIV-1 Infection, the Impact on the Viral Reservoir of a Combination Including Tenofovir/Emtricitabine and Dolutegravir or Tenofovir/Emtricitabine and Darunavir/Cobicistat</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ANRS, Emerging Infectious Diseases</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the impact of two combination of two tablets once&#xD;
      daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat&#xD;
      associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients&#xD;
      with primary HIV-1 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase III, randomized (1: 1), comparative, superiority, open-label, parallel assignment,&#xD;
      national multicenter trial evaluating two treatments in patients with primary HIV-1&#xD;
      infection.&#xD;
&#xD;
      Comparison of the two combinations regarding:&#xD;
&#xD;
        -  Viral reservoir at W48&#xD;
&#xD;
        -  Early inhibition of viral replication,&#xD;
&#xD;
        -  Plasmatic and cellular cumulative viremia at W48,&#xD;
&#xD;
        -  Immune reconstitution with CD4, CD8 levels and CD4 / CD8 ratio,&#xD;
&#xD;
        -  Activation parameters decrease,&#xD;
&#xD;
        -  Adherence to treatments,&#xD;
&#xD;
        -  Treatments tolerance,&#xD;
&#xD;
        -  Adverse events,&#xD;
&#xD;
        -  Quality of life (by self-administered questionnaires). Study of the pharmacokinetics /&#xD;
           dynamics relationship of the decay of plasma, cellular and spermatic compartments' viral&#xD;
           loads.&#xD;
&#xD;
           50 participants per group will be enrolled in 40 sites in France. Co- inclusion in ANRS&#xD;
           CO 06 PRIMO cohort will be offered&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV-DNA levels in the peripheral blood mononuclear cell (PBMC) at week 48</measure>
    <time_frame>week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative cellular viremia up to week 48</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative plasmatic viremia (HIV-1 RNA) at week 48</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative plasmatic viremia using the values obtained by ultrasensitive quantification for all HIV-1-RNA values &lt; 50 copies / mL.</measure>
    <time_frame>week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of HIV-1 RNA in plasma at week 2, week 4, week 8, week 12, week 24, week 36, week 48 and changes between week 0 and week 48</measure>
    <time_frame>week 2, week 4, week 8, week 12, week 24, week 36, week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with HIV-1 RNA &lt;50 copies / mL at week 2, week 4, week 8, week 12, week 24, week 36, week 48</measure>
    <time_frame>week 2, week 4, week 8, week 12, week 24, week 36, week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with HIV-1-RNA plasma below the ultrasensitive technique quantification threshold at week 2, week 4, week 8, week 12, week 24, week 36 and week 48</measure>
    <time_frame>week 2, week 4, week 8, week 12, week 24, week 36 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total DNA-HIV levels measured in PBMC at week 2, week 4, week 8, week 12, week 24, week 36 and week 48</measure>
    <time_frame>week 2, week 4, week 8, week 12, week 24, week 36 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total DNA-HIV levels measured in PBMC: changes between week 0 and week 48.</measure>
    <time_frame>between week 0 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 and CD8 counts and percentage at week 2, week 4, week 8, week 12, week 24, week 36, week 48.</measure>
    <time_frame>week 2, week 4, week 8, week 12, week 24, week 36, week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 and CD8 counts and percentage changes between week 0 and week 48.</measure>
    <time_frame>between week 0 and week 48.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4/CD8 ratio at week 2, week 4, week 8, week 12, week 24, week 36, week 48.</measure>
    <time_frame>week 2, week 4, week 8, week 12, week 24, week 36, week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4/CD8 ratio changes between week 0 and week 48.</measure>
    <time_frame>between week 0 and week 48.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: mean concentrations between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease.</measure>
    <time_frame>between week 0 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: cumulative AUC between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease.</measure>
    <time_frame>between week 0 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trial treatments tolerance using self-administered questionnaires of symptoms experienced.</measure>
    <time_frame>week 0, week 4, week 8, week 12, week 24, week 36 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported quality of life using self-administered questionnaire (PROQOL-HIV questionnaire).</measure>
    <time_frame>between week 0 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number, nature and time of occurrence of stage 3 or 4 clinical and biological adverse events (using ANRS scale to grade severity of adverse events in adults).</measure>
    <time_frame>between week 0 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV infection progression defined by occurrence of B or C stage clinical events or death between week 0 and week 48</measure>
    <time_frame>between week 0 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Metabolic disorders assessed by measurement of cholesterol, triglycerides, blood glucose and lipase</measure>
    <time_frame>between week 0 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of Renal function assessed by urea and serum creatinine.</measure>
    <time_frame>between week 0 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to treatments using self-administered questionnaires</measure>
    <time_frame>week 4, week 8, week 12, week 24, week 36 and week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to treatments using pills' counts by local pharmacist</measure>
    <time_frame>week 4, week 8, week 12, week 24 and week 36</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to treatments using MEMS (Medical Event Monitoring System) data collected during the first 3 months</measure>
    <time_frame>between week 0 and week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>HIV-1 Infection</condition>
  <arm_group>
    <arm_group_label>Dolutegravir + Emtricitabine/Tenofovir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will take Dolutegravir 50 mg (= Tivicay, 1 tablet per day) with Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Darunavir/Cobicistat + Emtricitabine/Ténofovir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will take Darunavir 800 mg / Cobicistat 150 mg (=Rezolsta, 1 tablet per day) + Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dolutegravir</intervention_name>
    <description>Oral use, 50mg/day</description>
    <arm_group_label>Dolutegravir + Emtricitabine/Tenofovir</arm_group_label>
    <other_name>Tivicay</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darunavir-cobicistat</intervention_name>
    <description>Oral use, 800-150mg/day</description>
    <arm_group_label>Darunavir/Cobicistat + Emtricitabine/Ténofovir</arm_group_label>
    <other_name>Rezolsta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Emtricitabine-Tenofovir</intervention_name>
    <description>Oral use, Emtricititabine : 200mg/day Ténofovir : 245mg</description>
    <arm_group_label>Darunavir/Cobicistat + Emtricitabine/Ténofovir</arm_group_label>
    <arm_group_label>Dolutegravir + Emtricitabine/Tenofovir</arm_group_label>
    <other_name>Truvada</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years at screening visit.&#xD;
&#xD;
          -  Patients with primary HIV-1 infection: Any results achieved in the previous 10 days of&#xD;
             inclusion visit will be taken into account. If the Enzyme Linked ImmunoSorbent Assay&#xD;
             (ELISA) test result does not dissociate the signals antibodies and p24 antigen or in&#xD;
             case of rapid test result :&#xD;
&#xD;
               -  Negative ELISA / rapid test and positive HIV-1 RNA confirmed by a second positive&#xD;
                  HIV-1 RNA.&#xD;
&#xD;
               -  Positive ELISA / rapid test and WB-HIV1 [0-5] band (s) or IB-HIV-1 [0-3] band(s)&#xD;
                  confirmed by a positive HIV-1 RNA.&#xD;
&#xD;
        If the ELISA test result dissociated p24 antigen and antibodies signals:&#xD;
&#xD;
          -  ELISA Ac - / p24 - and positive HIV-1 RNA confirmed by a second positive HIV-1 RNA.&#xD;
&#xD;
          -  ELISA Ac - / p24 + confirmed by a positive HIV-1 RNA.&#xD;
&#xD;
          -  ELISA Ac + / p24 + or - and WB-HIV1 [0-5] band (s) or IB-HIV-1 [0-3] band(s) confirmed&#xD;
             by a positive HIV-1 RNA.&#xD;
&#xD;
               -  Written informed consent signed by the person and the investigator no later than&#xD;
                  the day of the screening visit and before any exam performed in the trial&#xD;
                  (article L1122-1-1 Public Health Code).&#xD;
&#xD;
               -  Affiliate or beneficiary of a social security system (Article L1121-11 of the&#xD;
                  Public Health Code) (the State Medical Aid or AME is not a social security&#xD;
                  system).&#xD;
&#xD;
               -  Patients followed in selected centers, accepting additional constraints and&#xD;
                  having signed a consent, will participate to virological, immunological and&#xD;
                  pharmacological sub-studies.&#xD;
&#xD;
               -  Patient agreeing to participate in the trial for 1 year according to the defined&#xD;
                  terms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any antiretroviral treatment (for Pre-Exposure Prohylaxis or Post-exposure&#xD;
             prophylaxis) during the 4 weeks preceding inclusion.&#xD;
&#xD;
          -  Associated pathology with urgent care needed.&#xD;
&#xD;
          -  Prothrombin Ratio &lt; 50%.&#xD;
&#xD;
          -  Creatinine clearance &lt; 70 mL / min (Cockroft).&#xD;
&#xD;
          -  aspartate transaminase (AST), alanine transaminase (ALT), or bilirubin (total and&#xD;
             conjugated) ≥ 10 times the upper limit of normal.&#xD;
&#xD;
          -  Patient with isolated HIV-2 viral strain.&#xD;
&#xD;
          -  Women of childbearing potential without effective contraception method (see appendix&#xD;
             A6).&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
&#xD;
          -  Person under legal guardianship or deprived of liberty by a judicial or administrative&#xD;
             decision.&#xD;
&#xD;
          -  Patient participating in another research evaluating other treatments with an&#xD;
             exclusion period ongoing at the screening visit.&#xD;
&#xD;
          -  Planned absence which could prevent optimal trial participation (vacation abroad,&#xD;
             moving, imminent job change ...).&#xD;
&#xD;
          -  Co-administration of prohibited treatments (see § 9.5).&#xD;
&#xD;
          -  History or presence of allergy to the study drugs or their components;&#xD;
&#xD;
          -  Unstable liver disease (as defined by the presence of ascites, encephalopathy,&#xD;
             coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice),&#xD;
             known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic&#xD;
             gallstones).&#xD;
&#xD;
          -  Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh&#xD;
             classification.&#xD;
&#xD;
          -  Any symptoms or laboratory values suggesting a systemic disorder (renal, hepatic,&#xD;
             cardiovascular, pulmonary) or other medical conditions that could interfere with the&#xD;
             interpretation of trial results or compromise the health of patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoine Chéret, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Bicêtre</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>All The Regions Of The Country (40 Centers)</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>primary infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
    <mesh_term>Dolutegravir</mesh_term>
    <mesh_term>Darunavir</mesh_term>
    <mesh_term>Cobicistat</mesh_term>
    <mesh_term>Cobicistat mixture with darunavir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02987530
org study id: ANRS 169
secondary id: 2016-001683-11
nct id: NCT02987530
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the impact of two combination of two tablets once
      daily: dolutegravir associated with emtricitabine / tenofovir versus darunavir / cobicistat
      associated with emtricitabine / tenofovir on DNA HIV measured in PBMC at 48 weeks in patients
      with primary HIV-1 infection.
Phase III, randomized (1: 1), comparative, superiority, open-label, parallel assignment,
      national multicenter trial evaluating two treatments in patients with primary HIV-1
      infection.

      Comparison of the two combinations regarding:

        -  Viral reservoir at W48

        -  Early inhibition of viral replication,

        -  Plasmatic and cellular cumulative viremia at W48,

        -  Immune reconstitution with CD4, CD8 levels and CD4 / CD8 ratio,

        -  Activation parameters decrease,

        -  Adherence to treatments,

        -  Treatments tolerance,

        -  Adverse events,

        -  Quality of life (by self-administered questionnaires). Study of the pharmacokinetics /
           dynamics relationship of the decay of plasma, cellular and spermatic compartments' viral
           loads.

           50 participants per group will be enrolled in 40 sites in France. Co- inclusion in ANRS
           CO 06 PRIMO cohort will be offered
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HIV-DNA levels in the peripheral blood mononuclear cell (PBMC) at week 48
time frame: week 48
measure: Cumulative cellular viremia up to week 48
time frame: week 48
measure: Cumulative plasmatic viremia (HIV-1 RNA) at week 48
time frame: week 48
measure: Cumulative plasmatic viremia using the values obtained by ultrasensitive quantification for all HIV-1-RNA values < 50 copies / mL.
time frame: week 48
measure: Levels of HIV-1 RNA in plasma at week 2, week 4, week 8, week 12, week 24, week 36, week 48 and changes between week 0 and week 48
time frame: week 2, week 4, week 8, week 12, week 24, week 36, week 48
measure: Percentage of patients with HIV-1 RNA <50 copies / mL at week 2, week 4, week 8, week 12, week 24, week 36, week 48
time frame: week 2, week 4, week 8, week 12, week 24, week 36, week 48
measure: Proportion of patients with HIV-1-RNA plasma below the ultrasensitive technique quantification threshold at week 2, week 4, week 8, week 12, week 24, week 36 and week 48
time frame: week 2, week 4, week 8, week 12, week 24, week 36 and week 48
measure: Total DNA-HIV levels measured in PBMC at week 2, week 4, week 8, week 12, week 24, week 36 and week 48
time frame: week 2, week 4, week 8, week 12, week 24, week 36 and week 48
measure: Total DNA-HIV levels measured in PBMC: changes between week 0 and week 48.
time frame: between week 0 and week 48
measure: CD4 and CD8 counts and percentage at week 2, week 4, week 8, week 12, week 24, week 36, week 48.
time frame: week 2, week 4, week 8, week 12, week 24, week 36, week 48
measure: CD4 and CD8 counts and percentage changes between week 0 and week 48.
time frame: between week 0 and week 48.
measure: CD4/CD8 ratio at week 2, week 4, week 8, week 12, week 24, week 36, week 48.
time frame: week 2, week 4, week 8, week 12, week 24, week 36, week 48
measure: CD4/CD8 ratio changes between week 0 and week 48.
time frame: between week 0 and week 48.
measure: Pharmacokinetic: mean concentrations between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease.
time frame: between week 0 and week 48
measure: Pharmacokinetic: cumulative AUC between week 0 and week 48 will be linked to plasma RNA-VIH and DNA-VIH decrease.
time frame: between week 0 and week 48
measure: Trial treatments tolerance using self-administered questionnaires of symptoms experienced.
time frame: week 0, week 4, week 8, week 12, week 24, week 36 and week 48
measure: Reported quality of life using self-administered questionnaire (PROQOL-HIV questionnaire).
time frame: between week 0 and week 48
measure: Number, nature and time of occurrence of stage 3 or 4 clinical and biological adverse events (using ANRS scale to grade severity of adverse events in adults).
time frame: between week 0 and week 48
measure: HIV infection progression defined by occurrence of B or C stage clinical events or death between week 0 and week 48
time frame: between week 0 and week 48
measure: Evolution of Metabolic disorders assessed by measurement of cholesterol, triglycerides, blood glucose and lipase
time frame: between week 0 and week 48
measure: Evolution of Renal function assessed by urea and serum creatinine.
time frame: between week 0 and week 48
measure: Adherence to treatments using self-administered questionnaires
time frame: week 4, week 8, week 12, week 24, week 36 and week 48
measure: Adherence to treatments using pills' counts by local pharmacist
time frame: week 4, week 8, week 12, week 24 and week 36
measure: Adherence to treatments using MEMS (Medical Event Monitoring System) data collected during the first 3 months
time frame: between week 0 and week 12
arm group label: Dolutegravir + Emtricitabine/Tenofovir
arm group type: Experimental
description: Patients will take Dolutegravir 50 mg (= Tivicay, 1 tablet per day) with Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks
arm group label: Darunavir/Cobicistat + Emtricitabine/Ténofovir
arm group type: Active Comparator
description: Patients will take Darunavir 800 mg / Cobicistat 150 mg (=Rezolsta, 1 tablet per day) + Emtricitabine 200 mg / Ténofovir 245 mg (=Truvada, 1 tablet per day) for 48 weeks
intervention type: Drug
intervention name: Dolutegravir
description: Oral use, 50mg/day
arm group label: Dolutegravir + Emtricitabine/Tenofovir
other name: Tivicay
intervention type: Drug
intervention name: Darunavir-cobicistat
description: Oral use, 800-150mg/day
arm group label: Darunavir/Cobicistat + Emtricitabine/Ténofovir
other name: Rezolsta
intervention type: Drug
intervention name: Emtricitabine-Tenofovir
description: Oral use, Emtricititabine : 200mg/day Ténofovir : 245mg
arm group label: Darunavir/Cobicistat + Emtricitabine/Ténofovir
arm group label: Dolutegravir + Emtricitabine/Tenofovir
other name: Truvada
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoine Chéret, MD, PhD
role: Principal Investigator
affiliation: Hôpital Bicêtre
facility: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Dolutegravir
mesh term: Darunavir
mesh term: Cobicistat
mesh term: Cobicistat mixture with darunavir
sharing ipd: No