<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/NCT02211690</url>
  </required_header>
  <id_info>
    <org_study_id>2.0 dated 23 June 2014</org_study_id>
    <secondary_id>201047</secondary_id>
    <nct_id>NCT02211690</nct_id>
  </id_info>
  <brief_title>The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis</brief_title>
  <acronym>dPEP</acronym>
  <official_title>The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrew Carr</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ViiV Healthcare Australia Pty. Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 proportion of participants with non-occupational&#xD;
      post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to&#xD;
      follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants&#xD;
      who should and do cease study drug because:&#xD;
&#xD;
        1. The participant is found to be HIV-infected (study drugs will be ceased until the&#xD;
           genotype of the infecting strain is determined)&#xD;
&#xD;
        2. The source is found to be HIV-uninfected&#xD;
&#xD;
      The primary study objectives are:&#xD;
&#xD;
        1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using&#xD;
           dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)&#xD;
&#xD;
        2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP)&#xD;
           using dolutegravir with co-formulated emtricitabine-tenofovir&#xD;
&#xD;
      The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100)&#xD;
      eligible participants will receive dolutegravir (one tablet) with co-formulated&#xD;
      emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following&#xD;
      exposures:&#xD;
&#xD;
        1. receptive anal intercourse with a source known to be HIV-infected; or&#xD;
&#xD;
        2. receptive anal intercourse with a source of unknown HIV status; or&#xD;
&#xD;
        3. insertive anal intercourse with a source known to be HIV-infected&#xD;
&#xD;
      There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e.&#xD;
      to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed&#xD;
      at the investigator's discretion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Number of participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>twelve (12) weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>dolutegravir 50mg with co-formulated emtricitabine-tenofovir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dolutegravir 50 mg (one tablet daily)</intervention_name>
    <arm_group_label>dolutegravir 50mg with co-formulated emtricitabine-tenofovir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>emtricitabine-tenofovir 300/200 mg (one tablet daily)</intervention_name>
    <arm_group_label>dolutegravir 50mg with co-formulated emtricitabine-tenofovir</arm_group_label>
  </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. Potential HIV exposure following:&#xD;
&#xD;
               -  receptive anal intercourse with a source known to be HIV-infected; or&#xD;
&#xD;
               -  receptive anal intercourse with a source of unknown HIV status; or&#xD;
&#xD;
               -  insertive anal intercourse with a source known to be HIV-infected&#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;
          1. Non-sexual exposure&#xD;
&#xD;
          2. Exposure occurring during sex between a man and a woman&#xD;
&#xD;
          3. HIV infection diagnosed on baseline testing (antibody, Western blot, proviral DNA)&#xD;
             including indeterminate serology consistent with possible primary HIV infection&#xD;
&#xD;
          4. Use of any medication contra-indicated with DTG, FTC or TDF&#xD;
&#xD;
          5. Use of any medication that effects the concentration of dolutegravir and / or&#xD;
             concomitant drug including: oxcarbazepine, phenytoin, phenobarbital, carbamazepine,&#xD;
             rifampicin, metformin or St. John's wort (St John's wort can be stopped for the 28-day&#xD;
             period of NPEP).&#xD;
&#xD;
          6. History or presence of allergy to DTG, FTC, TDF or their components&#xD;
&#xD;
          7. Alanine aminotransferase (ALT) ≥5 times the upper limit of the reference range or ALT&#xD;
             ≥3 times and bilirubin ≥1.5 times the upper limit of the reference range&#xD;
&#xD;
          8. Unstable liver disease (as defined by the presence of ascites, encephalopathy,&#xD;
             coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent&#xD;
             jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or&#xD;
             asymptomatic gallstones)&#xD;
&#xD;
          9. Severe hepatic impairment (Class C) as determined by Child-Pugh classification&#xD;
&#xD;
         10. Serum estimated Glomerular Filtration Rate (eGFR) &lt;60 mL/min/BSAc&#xD;
&#xD;
         11. Current therapy for hepatitis B infection&#xD;
&#xD;
         12. Serological evidence of chronic/active hepatitis B&#xD;
&#xD;
         13. Previous OPEP/NPEP containing DTG&#xD;
&#xD;
         14. A participant with a history or current evidence of any condition, therapy, or&#xD;
             laboratory abnormality, or other circumstance that might confound the results of the&#xD;
             study, or interfere with the participant's participation for the full duration of the&#xD;
             study&#xD;
&#xD;
         15. Unable to complete study procedures&#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>St Vincent's Hospital Centre for Applied Medical Research</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydney Sexual Health Centre</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic 16, Royal North Shore Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melbourne Sexual Health Centre</name>
      <address>
        <city>Carlton</city>
        <state>Victoria</state>
        <zip>3053</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>May 25, 2016</last_update_submitted>
  <last_update_submitted_qc>May 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2016</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>Head Clinical research Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</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>
  </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/NCT02211690
org study id: 2.0 dated 23 June 2014
secondary id: 201047
nct id: NCT02211690
lead sponsor: 
collaborator: 
has dmc: No
This study aims to describe the proportion of participants with non-occupational
      post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to
      follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants
      who should and do cease study drug because:

        1. The participant is found to be HIV-infected (study drugs will be ceased until the
           genotype of the infecting strain is determined)

        2. The source is found to be HIV-uninfected

      The primary study objectives are:

        1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using
           dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF)

        2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP)
           using dolutegravir with co-formulated emtricitabine-tenofovir

      The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100)
      eligible participants will receive dolutegravir (one tablet) with co-formulated
      emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following
      exposures:

        1. receptive anal intercourse with a source known to be HIV-infected; or

        2. receptive anal intercourse with a source of unknown HIV status; or

        3. insertive anal intercourse with a source known to be HIV-infected

      There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e.
      to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed
      at the investigator's discretion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants with Adverse Events as a Measure of Safety and Tolerability
time frame: twelve (12) weeks
arm group label: dolutegravir 50mg with co-formulated emtricitabine-tenofovir
arm group type: Experimental
description: One-hundred eligible participants will receive dolutegravir (1 x 50mg tablet) with co-formulated emtricitabine-tenofovir (1 tablet) once daily for 28 days
intervention type: Drug
intervention name: dolutegravir 50 mg (one tablet daily)
arm group label: dolutegravir 50mg with co-formulated emtricitabine-tenofovir
intervention type: Drug
intervention name: emtricitabine-tenofovir 300/200 mg (one tablet daily)
arm group label: dolutegravir 50mg with co-formulated emtricitabine-tenofovir
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor-Investigator
investigator affiliation: St Vincent's Hospital
investigator full name: Andrew Carr
investigator title: Head Clinical research Program
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Dolutegravir