<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/NCT01715636</url>
  </required_header>
  <id_info>
    <org_study_id>1.0 dated 28 May 2012</org_study_id>
    <secondary_id>Carr (IN-AU-264-0119)</secondary_id>
    <nct_id>NCT01715636</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men.</brief_title>
  <acronym>EPEP</acronym>
  <official_title>Safety, Tolerability, and Adherence to Co-formulated Emtricitabine-rilpivirine-tenofovir Used as HIV Nonoccupational Post Exposure Prophylaxis in Men Who Have Sex With Men (EPEP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrew Carr</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St Vincent's Hospital, Sydney</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to describe the safety, tolerability and adherence to the coformulated&#xD;
      anti-HIV drug tenofovir-emtricitabine-rilpivirine (eviplera) when given to men who have sex&#xD;
      with men (MSM) following an actual or potential sexual exposure to HIV. This biomedical&#xD;
      intervention is known as nonoccupational post-exposure prophylaxis (NPEP). Patients receive&#xD;
      NPEP if they meet the criteria outlined in the 2007 National Australian NPEP Guidelines.&#xD;
      Three or two anti-HIV drugs are administered for 28-days depending on the severity of the the&#xD;
      assessed HIV acquisition risk. In this study eviplera would constitute 3-drug NPEP.&#xD;
      Tenofovir-emtricitabine (truvada) a component of eviplera has been used in NPEP at SVH since&#xD;
      2006.&#xD;
&#xD;
      This is a multi site, prospective, open-label, non-randomised trial. Participants will be MSM&#xD;
      who present at the various recruitment sites requesting NPEP. Initially, 50 eligible&#xD;
      participants will be assigned to receive eviplera 25mg once daily taken with food for 28-days&#xD;
      according to established Australian guidelines for the use of 3-drug NPEP. There will be 7&#xD;
      visits over a 12-week period. Follow-up post NPEP is for 8 weeks. If an interim analysis&#xD;
      demonstrates acceptable safety, it is proposed to seek ethics approval to increase the&#xD;
      samples size to 100 patients to gain more accurate information on regimen completion rate and&#xD;
      on-drug adherence.&#xD;
&#xD;
      The primary study objectives are:&#xD;
&#xD;
        1. To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF&#xD;
&#xD;
        2. To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF&#xD;
&#xD;
        3. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using&#xD;
           FTC-RPV-TDF&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera</measure>
    <time_frame>28 days</time_frame>
    <description>Objective AE and SAE data collection/grading utilising DAIDS data collection tool. Measurement of weight, electrolytes, urea, creatinine, eGFR, inorganic phosphate, calcium, liver function, glucose, amylase, lipase, creatine kinase, lactate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera</measure>
    <time_frame>28 days</time_frame>
    <description>Subjective reporting of AEs with data collection/grading utilising DAIDS-AE</description>
  </secondary_outcome>
  <other_outcome>
    <measure>on-drug adherence and regimen completion dates</measure>
    <time_frame>28 days</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men</condition>
  <arm_group>
    <arm_group_label>Eviplera</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg</intervention_name>
    <arm_group_label>Eviplera</arm_group_label>
    <other_name>Eviplera</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Man who has sex with men&#xD;
&#xD;
          2. Age at least 18 years&#xD;
&#xD;
          3. Eligible for 3-drug NPEP according to Australian guidelines for the use of 3-drug NPEP&#xD;
             following an actual or potential sexual exposure to HIV or receptive anal intercourse&#xD;
             with an unknown source&#xD;
&#xD;
          4. Able to provide written, informed consent&#xD;
&#xD;
          5. Able to commit to the study visits&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
          6. Non-sexual exposure&#xD;
&#xD;
          7. Exposure occurring during sex between a man and a woman&#xD;
&#xD;
          8. HIV infection diagnosed on day 1 serological testing including indeterminate serology&#xD;
             consistent with possible primary HIV infection&#xD;
&#xD;
          9. Use of any medication contraindicated with FTC-RPV-TDF&#xD;
&#xD;
         10. Serum hepatic transaminase (alanine aminotransferase [ALT] greater than 5 times the&#xD;
             upper limit of the normal range&#xD;
&#xD;
         11. Serum estimated Glomerular Filtration Rate (eGFR) &lt;60mL/min/ BSAc&#xD;
&#xD;
         12. Current therapy for hepatitis B&#xD;
&#xD;
         13. Day 1 serological evidence of chronic/active hepatitis B&#xD;
&#xD;
         14. Previous NPEP containing FTC-RPV-TDF&#xD;
&#xD;
         15. A patient with a history or current evidence of any condition, therapy, or laboratory&#xD;
             abnormality, or other circumstance that might confound the results of the study, or&#xD;
             interfere with the patient's participation for the full duration of the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sydney Sexual Heatlh Centre</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melbourne Sexual Health Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3053</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>January 8, 2015</last_update_submitted>
  <last_update_submitted_qc>January 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>St Vincent's Hospital</investigator_affiliation>
    <investigator_full_name>Andrew Carr</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>Rilpivirine</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/NCT01715636
org study id: 1.0 dated 28 May 2012
secondary id: Carr (IN-AU-264-0119)
nct id: NCT01715636
lead sponsor: 
has dmc: No
This study aims to describe the safety, tolerability and adherence to the coformulated
      anti-HIV drug tenofovir-emtricitabine-rilpivirine (eviplera) when given to men who have sex
      with men (MSM) following an actual or potential sexual exposure to HIV. This biomedical
      intervention is known as nonoccupational post-exposure prophylaxis (NPEP). Patients receive
      NPEP if they meet the criteria outlined in the 2007 National Australian NPEP Guidelines.
      Three or two anti-HIV drugs are administered for 28-days depending on the severity of the the
      assessed HIV acquisition risk. In this study eviplera would constitute 3-drug NPEP.
      Tenofovir-emtricitabine (truvada) a component of eviplera has been used in NPEP at SVH since
      2006.

      This is a multi site, prospective, open-label, non-randomised trial. Participants will be MSM
      who present at the various recruitment sites requesting NPEP. Initially, 50 eligible
      participants will be assigned to receive eviplera 25mg once daily taken with food for 28-days
      according to established Australian guidelines for the use of 3-drug NPEP. There will be 7
      visits over a 12-week period. Follow-up post NPEP is for 8 weeks. If an interim analysis
      demonstrates acceptable safety, it is proposed to seek ethics approval to increase the
      samples size to 100 patients to gain more accurate information on regimen completion rate and
      on-drug adherence.

      The primary study objectives are:

        1. To describe the safety of 28 days of NPEP using co-formulated FTC-RPV-TDF

        2. To describe the tolerability of 28 days of NPEP using FTC-RPV-TDF

        3. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using
           FTC-RPV-TDF
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To describe the safety of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
time frame: 28 days
description: Objective AE and SAE data collection/grading utilising DAIDS data collection tool. Measurement of weight, electrolytes, urea, creatinine, eGFR, inorganic phosphate, calcium, liver function, glucose, amylase, lipase, creatine kinase, lactate
measure: To describe the tolerability of 28 days of nonoccupational post-exposure prophylaxis with Eviplera
time frame: 28 days
description: Subjective reporting of AEs with data collection/grading utilising DAIDS-AE
measure: on-drug adherence and regimen completion dates
time frame: 28 days
arm group label: Eviplera
arm group type: Other
description: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg, one tablet, once daily, taken with food, for 28 days
intervention type: Drug
intervention name: Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg
arm group label: Eviplera
other name: Eviplera
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor-Investigator
investigator affiliation: St Vincent's Hospital
investigator full name: Andrew Carr
investigator title: Professor
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Rilpivirine