<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/NCT01701882</url>
  </required_header>
  <id_info>
    <org_study_id>SSAT 047</org_study_id>
    <nct_id>NCT01701882</nct_id>
  </id_info>
  <brief_title>A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine</brief_title>
  <official_title>A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Stephens Aids Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St Stephens Aids Trust</source>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the benefits of switching away from efavirenz&#xD;
      (which patients are taking in combination with Kivexa® or as part of the combination pill,&#xD;
      Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty&#xD;
      with sleeping}, bad dreams etc). The investigators in this study will investigate the effect&#xD;
      of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and&#xD;
      rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new&#xD;
      component of the combination.&#xD;
&#xD;
      Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination&#xD;
      with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical&#xD;
      studies, where patients were starting HIV treatment for the first time.&#xD;
&#xD;
      This study will also investigate the safety (in terms of other side effects and the routine&#xD;
      blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness,&#xD;
      your viral load and CD4 counts, when you switch treatment to&#xD;
      tenofovir/emtricitabine/rilpivirine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Resolution of toxicity after 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>To investigate whether switching individuals with intolerance to efavirenz-containing cART (as Atripla or Kivexa plus Efavarinz) to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 12 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resolution of toxicity after 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
    <description>To investigate whether switching to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 24 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>tenofovir/emtricitabine/rilpivirine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A one pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tenofovir/emtricitabine/rilpivirine</intervention_name>
    <arm_group_label>tenofovir/emtricitabine/rilpivirine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient volunteers who meet all of the following criteria are eligible for this trial:&#xD;
&#xD;
               1. Is male or female aged 18 years or above&#xD;
&#xD;
               2. Has HIV-1 infection documented in their medical notes&#xD;
&#xD;
               3. Has signed the Informed Consent Form voluntarily&#xD;
&#xD;
               4. Is willing to comply with the protocol requirements&#xD;
&#xD;
               5. Has been on Atripla for at least 12 weeks OR Kivexa plus efavirenz&#xD;
&#xD;
               6. Has an HIV-plasma viral load at screening &lt;50 copies/mL (single re-test allowed)&#xD;
&#xD;
               7. Has a CD4 cell count at screening &gt;50 cells/mm3&#xD;
&#xD;
               8. Estimated glomerular filtration rate (MDRD) &gt;50 ml/min.&#xD;
&#xD;
               9. Has symptomatic CNS related toxicity associated with EFV&#xD;
&#xD;
              10. If female and of childbearing potential, is using effective birth control methods&#xD;
                  (as agreed by the investigator) and is willing to continue practising these birth&#xD;
                  control methods during the trial and for at least 30 days after the end of the&#xD;
                  trial. Note: Women who are postmenopausal for least 2 years, women with total&#xD;
                  hysterectomy, and women who have a tubal ligation are considered of&#xD;
                  non-childbearing potential&#xD;
&#xD;
              11. If a heterosexually active male, he is using effective birth control methods and&#xD;
                  is willing to continue practising these birth control methods during the trial&#xD;
                  and until follow-up visit&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Patients meeting 1 or more of the following criteria cannot be selected:&#xD;
&#xD;
               1. Infected with HIV-2&#xD;
&#xD;
               2. Using any concomitant therapy disallowed as per SPC for the study drugs (note&#xD;
                  acid-reducing agents and interaction with rilpivirine)&#xD;
&#xD;
               3. Has acute viral hepatitis including, but not limited to, A, B, or C&#xD;
&#xD;
               4. Has chronic hepatitis B and/or C with AST and/or ALT &gt;5 x ULN Note: Subjects can&#xD;
                  enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable&#xD;
                  result in last 6 months) and with chronic HCV if not expected to require&#xD;
                  treatment during the trial period.&#xD;
&#xD;
               5. Any investigational drug within 30 days prior to the trial drug administration&#xD;
&#xD;
               6. Has received rilpivirine in the past&#xD;
&#xD;
               7. Any clinical evidence of baseline resistance mutations&#xD;
&#xD;
               8. Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and&#xD;
                  patients with galactose intolerance, the Lapp lactase deficiency, or&#xD;
                  glucose-galactose malabsorption&#xD;
&#xD;
               9. Severe hepatic impairment&#xD;
&#xD;
              10. Moderate or severe renal impairment (creatinine clearance &lt; 50ml/min)&#xD;
&#xD;
              11. If female, she is pregnant or breastfeeding&#xD;
&#xD;
              12. Screening blood result with any grade 3/4 toxicity according to Division of AIDS&#xD;
                  (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid&#xD;
                  elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).&#xD;
&#xD;
              13. Any condition (including drug/alcohol abuse) or laboratory results which, in the&#xD;
                  investigator's opinion, interfere with assessments or completion of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St Stephen's AIDS Trust</name>
      <address>
        <city>London</city>
        <zip>SW10 9TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</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>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/NCT01701882
org study id: SSAT 047
nct id: NCT01701882
lead sponsor: 
The purpose of the study is to investigate the benefits of switching away from efavirenz
      (which patients are taking in combination with Kivexa® or as part of the combination pill,
      Atripla®) in patients with central nervous system side effects (such as insomnia {difficulty
      with sleeping}, bad dreams etc). The investigators in this study will investigate the effect
      of switching to a single tablet regimen (Eviplera®) containing tenofovir, emtricitabine and
      rilpivirine. If patients are currently taking Atripla, rilpivirine will be the only new
      component of the combination.

      Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination
      with Truvada®, it showed fewer side effects when compared to efavirenz in 2 other clinical
      studies, where patients were starting HIV treatment for the first time.

      This study will also investigate the safety (in terms of other side effects and the routine
      blood tests which we ordinarily use to monitor your treatment) and monitor effectiveness,
      your viral load and CD4 counts, when you switch treatment to
      tenofovir/emtricitabine/rilpivirine.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Resolution of toxicity after 12 weeks
time frame: 12 weeks
description: To investigate whether switching individuals with intolerance to efavirenz-containing cART (as Atripla or Kivexa plus Efavarinz) to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 12 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.
measure: Resolution of toxicity after 24 weeks
time frame: 24 weeks
description: To investigate whether switching to tenofovir/emtricitabine/rilpivirine is associated with resolution of toxicity after 24 weeks. CNS toxicity will be measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale.
arm group label: tenofovir/emtricitabine/rilpivirine
arm group type: Experimental
description: A one pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily.
intervention type: Drug
intervention name: tenofovir/emtricitabine/rilpivirine
arm group label: tenofovir/emtricitabine/rilpivirine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Rilpivirine