<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/NCT02198443</url>
  </required_header>
  <id_info>
    <org_study_id>STRIB-PEP</org_study_id>
    <nct_id>NCT02198443</nct_id>
  </id_info>
  <brief_title>Comparison of Two Combinations in Antiretroviral Post-Exposure Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.</brief_title>
  <acronym>STRIB-PEP</acronym>
  <official_title>Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion Clinic per a la Recerca Biomédica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion Clinic per a la Recerca Biomédica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to compare the tolerability and adherence to a new drug&#xD;
      regimen of post-exposure prophylaxis (PEP) for HIV,&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2015</start_date>
  <primary_completion_date type="Actual">July 15, 2016</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason</measure>
    <time_frame>Twenty Eigth days</time_frame>
    <description>A subject is considered to abandon treatment if within 28 days&#xD;
dies&#xD;
Do not come to visit week 4&#xD;
changed or discontinued study treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinical adverse events and / or laboratory alterations.</measure>
    <time_frame>twenty-four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up</measure>
    <time_frame>twenty four weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>degree of adhesion during the treatment period</measure>
    <time_frame>twenty eight days</time_frame>
    <description>Measured by pill count and patient adherence questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to loss of adherence to TARV</measure>
    <time_frame>twenty eight days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.</measure>
    <time_frame>twenty four weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Tenofovir+emtricitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)</intervention_name>
    <description>(TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets</description>
    <arm_group_label>Tenofovir+emtricitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil</intervention_name>
    <description>Film-coated tablets of 150 mg of elvitegravir, cobicistat 150 mg, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil. One tablet once / day.</description>
    <arm_group_label>Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil</arm_group_label>
    <other_name>(Stribild)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years&#xD;
&#xD;
          -  Have been exposed to HIV, non-occupational and meets the requirements of current&#xD;
             recommendations to start with three antiretroviral drugs PEP&#xD;
&#xD;
          -  that adequately informed consent in writing to participate in the study and undergo&#xD;
             testing and exploration that entails&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women, lactating, or those intend become pregnant during the study period.&#xD;
&#xD;
          -  subjects who are known or suspected case presents the source resistors to one of the&#xD;
             drugs of the pattern of study&#xD;
&#xD;
          -  contraindicated treatment with the study drugs, or products under investigation&#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>Felipe García, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital clínic y provincial de Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital clínico y provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinic per a la Recerca Biomédica</investigator_affiliation>
    <investigator_full_name>Anna Cruceta</investigator_full_name>
    <investigator_title>project manager</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Lopinavir</mesh_term>
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
    <mesh_term>Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
    <mesh_term>Cobicistat</mesh_term>
    <mesh_term>Elvitegravir</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02198443
org study id: STRIB-PEP
nct id: NCT02198443
lead sponsor: 
has dmc: No
The main objective of this study is to compare the tolerability and adherence to a new drug
      regimen of post-exposure prophylaxis (PEP) for HIV,
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of patients who leave the initial treatment of post-exposure prophylaxis (PEP) for HIV for any reason
time frame: Twenty Eigth days
description: A subject is considered to abandon treatment if within 28 days
dies
Do not come to visit week 4
changed or discontinued study treatment.
measure: Incidence of clinical adverse events and / or laboratory alterations.
time frame: twenty-four weeks
measure: Proportion of patients who discontinued treatment due to toxicity or intolerance in each of the treatment arms at 24 weeks follow-up
time frame: twenty four weeks
measure: degree of adhesion during the treatment period
time frame: twenty eight days
description: Measured by pill count and patient adherence questionnaire
measure: time to loss of adherence to TARV
time frame: twenty eight days
measure: Proportion of patients with seroconversion in both treatment arms at 24 weeks follow-up.
time frame: twenty four weeks
arm group label: Tenofovir+emtricitabine
arm group type: Active Comparator
arm group label: Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil
arm group type: Experimental
intervention type: Drug
intervention name: Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)
description: (TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets
arm group label: Tenofovir+emtricitabine
intervention type: Drug
intervention name: elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil
description: Film-coated tablets of 150 mg of elvitegravir, cobicistat 150 mg, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil. One tablet once / day.
arm group label: Elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil
other name: (Stribild)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Felipe García, MD
role: Principal Investigator
affiliation: Hospital clínic y provincial de Barcelona
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Anna Cruceta
investigator title: project manager
mesh term: Ritonavir
mesh term: Lopinavir
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
mesh term: Cobicistat
mesh term: Elvitegravir