xml: <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/NCT06034938</url>
    </required_header>
    <id_info>
      <org_study_id>MISP-RC_Parienti007</org_study_id>
      <nct_id>NCT06034938</nct_id>
    </id_info>
    <brief_title>DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)</brief_title>
    <acronym>DOR</acronym>
    <official_title>DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Merck Sharp &amp; Dohme LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Caen</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral&#xD;
        combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in&#xD;
        participants with suppressed HIV who previously developed M184V/I mutation that confers&#xD;
        resistance to 3TC. The main question it aims to answer is to explore the rate of HIV&#xD;
        suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until&#xD;
        48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the&#xD;
        HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to&#xD;
        DOR/3TC/TDF with careful HIV-RNA monitoring.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>Open-label, non-comparative, single arm pilot trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Plasma HIV-RNA at 24-week</measure>
      <time_frame>24 weeks from the switch to DOR/3TC/TDF</time_frame>
      <description>Number of copies/mL</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma HIV-RNA at 48-week</measure>
      <time_frame>48 weeks from the switch to DOR/3TC/TDF</time_frame>
      <description>Number of copies/mL</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Hiv</condition>
    <arm_group>
      <arm_group_label>Single arm DOR/3TC/TDF</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Doravirine 100 mg Lamivudine 300 mg Tenofovir disoproxil fumarate 245 mg Delstrigo (R): 1 pill/day for 48 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]</intervention_name>
      <description>Switch previous therapy with DOR/TDF/3TC</description>
      <arm_group_label>Single arm DOR/3TC/TDF</arm_group_label>
      <other_name>Delstrigo</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult living with HIV&#xD;
  &#xD;
            -  Receiving stable antiretroviral treatment for at least 3 months&#xD;
  &#xD;
            -  HIV RNA VL&lt;50cp/mL for at least 6 months&#xD;
  &#xD;
            -  Presence of the M184V/I mutation in at least one previous genotype performed on plasma&#xD;
               HIV RNA but absent from the genotype on current standard pro-viral DNA (Sanger&#xD;
               technique)&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of genotypic mutation associated with resistance to DOR or TDF according to&#xD;
               the ANRS version 32 algorithm, i.e. :&#xD;
  &#xD;
            -  For DOR : V106A/M; Y188L; G190E/S; M230L; L100I + K103N; K103N + Y181C; K103N + P225H;&#xD;
               F227C; At least 3 amongst: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y&#xD;
  &#xD;
            -  For TDF : At least 3 mutations among: M41L, E44D, D67N, T69D/N/S, L74V/I, L210W,&#xD;
               T215A/C/D/E/G/H/I/L/N/S/V/Y/F; K65R/E/N ; Insertion at codon 69; K70E&#xD;
  &#xD;
            -  Contraindications to the use of DOR/TDF/3TC&#xD;
  &#xD;
            -  Hypersensitivity to doravirine, tenofovir, lamivudine or any of the excipients&#xD;
               (lactose in particular)&#xD;
  &#xD;
            -  Current or recent treatment with a strong CYP3A4 inducer&#xD;
  &#xD;
            -  Breast-feeding&#xD;
  &#xD;
            -  Patients already on DOR&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#xD;
  &#xD;
            -  Patients under guardianship or trusteeship&#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_contact>
      <last_name>Jean-Jacques Parienti, MD, PhD</last_name>
      <phone>+33231064320</phone>
      <email>parienti-jj@chu-caen.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Francois Fournel, MSc</last_name>
      <email>fournel-f@chu-caen.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU de Caen</name>
        <address>
          <city>Caen</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>CHU Orléans</name>
        <address>
          <city>Orléans</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Laurent Hocqueloux, MD</last_name>
      </contact>
      <contact_backup>
        <phone>+33238514444</phone>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>CHU Rouen</name>
        <address>
          <city>Rouen</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Manuel Etienne, MD, PhD</last_name>
        <phone>+33 232888990</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>CH Tourcoing</name>
        <address>
          <city>Tourcoing</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Olivier Robineau</last_name>
        <phone>+33 320694949</phone>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>doravirine</keyword>
    <keyword>M184 mutation</keyword>
    <keyword>Maintenance therapy</keyword>
    <keyword>PLWH</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tenofovir</mesh_term>
      <mesh_term>Lamivudine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Contact principal investigator</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>2-year after publishing the princeps study</ipd_time_frame>
      <ipd_access_criteria>Relevant scientific question with protocol</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034938
  org study id: MISP-RC_Parienti007
  nct id: NCT06034938
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral
        combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in
        participants with suppressed HIV who previously developed M184V/I mutation that confers
        resistance to 3TC. The main question it aims to answer is to explore the rate of HIV
        suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until
        48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the
        HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to
        DOR/3TC/TDF with careful HIV-RNA monitoring.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Open-label, non-comparative, single arm pilot trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Plasma HIV-RNA at 24-week
  time frame: 24 weeks from the switch to DOR/3TC/TDF
  description: Number of copies/mL
  measure: Plasma HIV-RNA at 48-week
  time frame: 48 weeks from the switch to DOR/3TC/TDF
  description: Number of copies/mL
  arm group label: Single arm DOR/3TC/TDF
  arm group type: Experimental
  description: Doravirine 100 mg Lamivudine 300 mg Tenofovir disoproxil fumarate 245 mg Delstrigo (R): 1 pill/day for 48 weeks
  intervention type: Drug
  intervention name: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
  description: Switch previous therapy with DOR/TDF/3TC
  arm group label: Single arm DOR/3TC/TDF
  other name: Delstrigo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jean-Jacques Parienti, MD, PhD
  phone: +33231064320
  email: parienti-jj@chu-caen.fr
  last name: Francois Fournel, MSc
  email: fournel-f@chu-caen.fr
  facility: 
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Tenofovir
  mesh term: Lamivudine
  sharing ipd: Yes
  ipd description: Contact principal investigator
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 2-year after publishing the princeps study
  ipd access criteria: Relevant scientific question with protocol