<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/NCT02998320</url>
  </required_header>
  <id_info>
    <org_study_id>GEFR1044015</org_study_id>
    <nct_id>NCT02998320</nct_id>
  </id_info>
  <brief_title>Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis</brief_title>
  <official_title>Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux</source>
  <oversight_info>
    <has_dmc>No</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>
      This study measures the proportion of enrolled patients taking the uninterrupted HIV&#xD;
      post-exposure prophylaxis Genvoya for four weeks&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study measures the proportion of enrolled patients taking the uninterrupted HIV&#xD;
      post-exposure prophylaxis Elvitegravir/Cobicistat/FTC/Tenofovir alafenamide (E/C/F/TAF) for&#xD;
      four Weeks.&#xD;
&#xD;
      Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Cobicistat is a&#xD;
      selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily.&#xD;
      Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue&#xD;
      àf 2'-dexicytidine. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor&#xD;
      (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks</measure>
    <time_frame>Day 28</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>HIV Risk</condition>
  <arm_group>
    <arm_group_label>Genvoya</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genvoya</intervention_name>
    <description>Oral use (one tablet each day); 150/150/200/10 mg; 28 days</description>
    <arm_group_label>Genvoya</arm_group_label>
    <other_name>(E/C/F/TAF) ATC Code: J05AR18</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  an age above 18 years&#xD;
&#xD;
          -  consultation within 48 hours following a risk of HIV transmission (blood or sexual&#xD;
             contact)&#xD;
&#xD;
          -  indication for HIV post-exposure prophylaxis (according to French guidelines)&#xD;
&#xD;
          -  person able to understand the nature of the study&#xD;
&#xD;
          -  person who signed his consent form to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  person exposed to HIV risk from person infected by HIV, whose therapeutic history&#xD;
             justifies the prescription of another combination of antiretroviral drugs&#xD;
&#xD;
          -  contraindications to the prescription of Genvoy&#xD;
&#xD;
          -  other medical contraindications&#xD;
&#xD;
          -  person infected by hepatitis B virus&#xD;
&#xD;
          -  pregnant or lactating woman&#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>David Rey</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpitaux Universitaires de Strasbourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-André</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ambroise Paré</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Manchester</name>
      <address>
        <city>Charleville-Mézières</city>
        <zip>08011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>77908</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>CHR de Metz</name>
      <address>
        <city>Metz</city>
        <zip>57050</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GH Pitié Salpetriere</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Tourcoing</name>
      <address>
        <city>Tourcoing</city>
        <zip>59208</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_browse>
  <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/NCT02998320
org study id: GEFR1044015
nct id: NCT02998320
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study measures the proportion of enrolled patients taking the uninterrupted HIV
      post-exposure prophylaxis Genvoya for four weeks
This study measures the proportion of enrolled patients taking the uninterrupted HIV
      post-exposure prophylaxis Elvitegravir/Cobicistat/FTC/Tenofovir alafenamide (E/C/F/TAF) for
      four Weeks.

      Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Cobicistat is a
      selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily.
      Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue
      àf 2'-dexicytidine. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor
      (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
time frame: Day 28
arm group label: Genvoya
arm group type: Experimental
description: Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days
intervention type: Drug
intervention name: Genvoya
description: Oral use (one tablet each day); 150/150/200/10 mg; 28 days
arm group label: Genvoya
other name: (E/C/F/TAF) ATC Code: J05AR18
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Rey
role: Principal Investigator
affiliation: Hôpitaux Universitaires de Strasbourg
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
sharing ipd: No