<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/NCT01690403</url>
  </required_header>
  <id_info>
    <org_study_id>INT12291</org_study_id>
    <secondary_id>U1111-1131-1992</secondary_id>
    <nct_id>NCT01690403</nct_id>
  </id_info>
  <brief_title>Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients</brief_title>
  <official_title>An Open-label, Non-randomized, Single Sequence, Two Periods, Four-treatment, Three Parallel Groups Pharmacokinetic Interaction Study of Repeated Oral Doses (Daily or Weekly Regimen) of Rifapentine on ATRIPLA™ (Fixed Dose Combination of Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate) Given to HIV+ Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      - To evaluate the effect of single and repeated administration of rifapentine given as daily&#xD;
      or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and&#xD;
      tenofovir given as a fixed dose combination (ATRIPLA™ ).&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      - To evaluate the safety and tolerability of concomitant administration of rifapentine and&#xD;
      ATRIPLA™ given to HIV+ patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Screening to admission: up to 21 days&#xD;
&#xD;
        -  Admission to the end of the follow-up: up to 41 days&#xD;
&#xD;
             -  Period 1: Treatment period of 15 days with ATRIPLA™ (background therapy). Patients&#xD;
                should receive the same regimen and dose of ATRIPLA™ during the all study screening&#xD;
                and period 1.&#xD;
&#xD;
             -  Period 2: Treatment over a period of 21 days in co-administration with rifapentine.&#xD;
&#xD;
             -  Follow up: 3 to 5 days after the last rifapentine administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine PK parameters Cmax, Cmin and AUC0-24 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)</measure>
    <time_frame>Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2 ,Day 1 and Day 16 for cohort 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine PK parameters t1/2z, tmax for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)</measure>
    <time_frame>Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine PK parameters tlag, CL/F for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)</measure>
    <time_frame>Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine PK parameter for AUC0-10 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)</measure>
    <time_frame>Day -2 and Day 1 for cohorts 1 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR)</measure>
    <time_frame>Cohort 2: Day 1, 8, and 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR)</measure>
    <time_frame>Cohort 2: Day 1, 8, and 15</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cohort 3 (optional)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rifapentine (M000473)</intervention_name>
    <description>Pharmaceutical form:tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>cohort 1</arm_group_label>
    <arm_group_label>cohort 2</arm_group_label>
    <arm_group_label>cohort 3 (optional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EFZ EMT TDF</intervention_name>
    <description>Pharmaceutical form:tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>cohort 1</arm_group_label>
    <arm_group_label>cohort 2</arm_group_label>
    <arm_group_label>cohort 3 (optional)</arm_group_label>
    <other_name>ATRIPLA™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
        - HIV+ male and female patients receiving ATRIPLA™ aged 18 to 55 years old with a CD4 count&#xD;
        cells of at least 350&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Any history or presence of clinically relevant cardiovascular, pulmonary,&#xD;
             gastrointestinal, hepatic, renal, metabolic, haematological (patients with porphyria),&#xD;
             neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic&#xD;
             (if female), or infectious disease, or signs of acute illness other than HIV disease.&#xD;
&#xD;
          -  Active or latent tuberculosis infection&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 840001</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>February 26, 2015</last_update_submitted>
  <last_update_submitted_qc>February 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifapentine</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/NCT01690403
org study id: INT12291
secondary id: U1111-1131-1992
nct id: NCT01690403
lead sponsor: 
has dmc: No
Primary Objective:

      - To evaluate the effect of single and repeated administration of rifapentine given as daily
      or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and
      tenofovir given as a fixed dose combination (ATRIPLA™ ).

      Secondary Objective:

      - To evaluate the safety and tolerability of concomitant administration of rifapentine and
      ATRIPLA™ given to HIV+ patients
-  Screening to admission: up to 21 days

        -  Admission to the end of the follow-up: up to 41 days

             -  Period 1: Treatment period of 15 days with ATRIPLA™ (background therapy). Patients
                should receive the same regimen and dose of ATRIPLA™ during the all study screening
                and period 1.

             -  Period 2: Treatment over a period of 21 days in co-administration with rifapentine.

             -  Follow up: 3 to 5 days after the last rifapentine administration.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: To determine PK parameters Cmax, Cmin and AUC0-24 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)
time frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2 ,Day 1 and Day 16 for cohort 2
measure: To determine PK parameters t1/2z, tmax for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)
time frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2
measure: To determine PK parameters tlag, CL/F for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)
time frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2
measure: To determine PK parameter for AUC0-10 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)
time frame: Day -2 and Day 1 for cohorts 1 and 3
measure: To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR)
time frame: Cohort 2: Day 1, 8, and 15
measure: To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR)
time frame: Cohort 2: Day 1, 8, and 15
arm group label: cohort 1
arm group type: Experimental
description: Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1).
arm group label: cohort 2
arm group type: Experimental
description: Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2).
arm group label: cohort 3 (optional)
arm group type: Experimental
description: Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3).
intervention type: Drug
intervention name: rifapentine (M000473)
description: Pharmaceutical form:tablet
Route of administration: oral
arm group label: cohort 1
arm group label: cohort 2
arm group label: cohort 3 (optional)
intervention type: Drug
intervention name: EFZ EMT TDF
description: Pharmaceutical form:tablet
Route of administration: oral
arm group label: cohort 1
arm group label: cohort 2
arm group label: cohort 3 (optional)
other name: ATRIPLA™
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Rifapentine