<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/NCT02976259</url>
  </required_header>
  <id_info>
    <org_study_id>IMEA 051</org_study_id>
    <nct_id>NCT02976259</nct_id>
  </id_info>
  <brief_title>Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection</brief_title>
  <acronym>DOLUPRIM</acronym>
  <official_title>Kinetics of HIV-RNA Decay in Seminal Plasma of Men Receiving a Dolutegravir-based Regimen at the Time of Primary HIV Infection (IMEA 051-DOLUPRIM Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue&#xD;
      Henri Huchard - 75018 PARIS Tél. : 01.40. 25. 63. 65 - Fax : 01.40.25.63.56&#xD;
&#xD;
      Coordinating investigator:&#xD;
&#xD;
      Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses&#xD;
&#xD;
      1 avenue Claude Vellefaux - 75010 PARIS Tél. : 01 42 49 49 73 - Fax : 01 42 49 47 43 E-mail :&#xD;
      caroline.lascoux-combe@aphp.fr&#xD;
&#xD;
      Participating country : FRANCE&#xD;
&#xD;
      Primary objective : Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal&#xD;
      plasma in patients starting a triple combination regimen with dolutegravir + tenofovir DF&#xD;
      (TDF) + emtricitabine (FTC) at the time of PHI.&#xD;
&#xD;
      Secondary objectives :&#xD;
&#xD;
        -  Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal&#xD;
           plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48&#xD;
&#xD;
        -  To assess the frequency of intermittent shedding in seminal plasma once virological&#xD;
           suppression has been achieved and until W48&#xD;
&#xD;
        -  Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48&#xD;
&#xD;
        -  Comparison of dolutegravir concentration in blood plasma and seminal plasma&#xD;
&#xD;
        -  Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma&#xD;
&#xD;
        -  Analysis by deep sequencing of the viral population (quasi-species) in both compartments&#xD;
           (blood plasma and seminal plasma) before virological suppression has been achieved (i.e.&#xD;
           at D0 and W12)&#xD;
&#xD;
      Inclusion criteria :&#xD;
&#xD;
        -  Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or&#xD;
           indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a&#xD;
           western blot profile compatible with ongoing seroconversion (incomplete western blot&#xD;
           with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative&#xD;
           test for HIV antibodies followed within 3 months by a positive HIV serology&#xD;
&#xD;
        -  Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245&#xD;
           mg/200 mg) initiated by the referee physician within a maximum of 15 days after&#xD;
           diagnosis of PHI&#xD;
&#xD;
        -  Genotypic sensitivity to TDF, FTC and DTG&#xD;
&#xD;
        -  Patient with medical care insurance&#xD;
&#xD;
      Exclusion criteria :&#xD;
&#xD;
        -  Chronic infection&#xD;
&#xD;
        -  Infection or co-infection with HIV-2&#xD;
&#xD;
      Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients&#xD;
      (exploratory study)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondary objectives :&#xD;
&#xD;
        -  Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal&#xD;
           plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48&#xD;
&#xD;
        -  To assess the frequency of intermittent shedding in seminal plasma once virological&#xD;
           suppression has been achieved and until W48&#xD;
&#xD;
        -  Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48&#xD;
&#xD;
        -  Comparison of dolutegravir concentration in blood plasma and seminal plasma&#xD;
&#xD;
        -  Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma&#xD;
&#xD;
        -  Analysis by deep sequencing of the viral population (quasi-species) in both compartments&#xD;
           (blood plasma and seminal plasma) before virological suppression has been achieved (i.e.&#xD;
           at D0 and W12)&#xD;
&#xD;
      Inclusion criteria :&#xD;
&#xD;
        -  Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or&#xD;
           indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a&#xD;
           western blot profile compatible with ongoing seroconversion (incomplete western blot&#xD;
           with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative&#xD;
           test for HIV antibodies followed within 3 months by a positive HIV serology&#xD;
&#xD;
        -  Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245&#xD;
           mg/200 mg) initiated by the referee physician within a maximum of 15 days after&#xD;
           diagnosis of PHI&#xD;
&#xD;
        -  Genotypic sensitivity to TDF, FTC and DTG&#xD;
&#xD;
        -  Patient with medical care insurance&#xD;
&#xD;
      Exclusion criteria :&#xD;
&#xD;
        -  Chronic infection&#xD;
&#xD;
        -  Infection or co-infection with HIV-2&#xD;
&#xD;
      Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients&#xD;
      (exploratory study)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid</measure>
    <time_frame>2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks</time_frame>
    <description>Measure of HIV-RNA level in blood plasma and seminal fluid at each point and comparaison about the decay between both</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid</measure>
    <time_frame>Day 0 and 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of dolutegravir concentration in blood plasma and seminal fluid</measure>
    <time_frame>2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks</time_frame>
    <description>Measure of doltegravir concentration in blood and seminal fluid at each points and comparaison of the value between the 2 compartments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved</measure>
    <time_frame>Day 0 and 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>HIV Infection Primary</condition>
  <arm_group>
    <arm_group_label>Patient HIV primary infection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HIV primary infection Patient male receiving Dolutegravir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dolutegravir</intervention_name>
    <description>All patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples)</description>
    <arm_group_label>Patient HIV primary infection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or&#xD;
             indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii)&#xD;
             a western blot profile compatible with ongoing seroconversion (incomplete western blot&#xD;
             with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative&#xD;
             test for HIV antibodies followed within 3 months by a positive HIV serology&#xD;
&#xD;
          -  Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245&#xD;
             mg/200 mg) initiated by the referee physician within a maximum of 15 days after&#xD;
             diagnosis of PHI&#xD;
&#xD;
          -  Genotypic sensitivity to TDF, FTC and DTG&#xD;
&#xD;
          -  Patient with medical care insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic infection&#xD;
&#xD;
          -  Infection or co-infection with HIV-2&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2019</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dolutegravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02976259
org study id: IMEA 051
nct id: NCT02976259
lead sponsor: 
has dmc: No
Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue
      Henri Huchard - 75018 PARIS Tél. : 01.40. 25. 63. 65 - Fax : 01.40.25.63.56

      Coordinating investigator:

      Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses

      1 avenue Claude Vellefaux - 75010 PARIS Tél. : 01 42 49 49 73 - Fax : 01 42 49 47 43 E-mail :
      caroline.lascoux-combe@aphp.fr

      Participating country : FRANCE

      Primary objective : Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal
      plasma in patients starting a triple combination regimen with dolutegravir + tenofovir DF
      (TDF) + emtricitabine (FTC) at the time of PHI.

      Secondary objectives :

        -  Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal
           plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48

        -  To assess the frequency of intermittent shedding in seminal plasma once virological
           suppression has been achieved and until W48

        -  Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48

        -  Comparison of dolutegravir concentration in blood plasma and seminal plasma

        -  Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma

        -  Analysis by deep sequencing of the viral population (quasi-species) in both compartments
           (blood plasma and seminal plasma) before virological suppression has been achieved (i.e.
           at D0 and W12)

      Inclusion criteria :

        -  Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or
           indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a
           western blot profile compatible with ongoing seroconversion (incomplete western blot
           with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative
           test for HIV antibodies followed within 3 months by a positive HIV serology

        -  Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245
           mg/200 mg) initiated by the referee physician within a maximum of 15 days after
           diagnosis of PHI

        -  Genotypic sensitivity to TDF, FTC and DTG

        -  Patient with medical care insurance

      Exclusion criteria :

        -  Chronic infection

        -  Infection or co-infection with HIV-2

      Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients
      (exploratory study)
Secondary objectives :

        -  Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal
           plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48

        -  To assess the frequency of intermittent shedding in seminal plasma once virological
           suppression has been achieved and until W48

        -  Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48

        -  Comparison of dolutegravir concentration in blood plasma and seminal plasma

        -  Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma

        -  Analysis by deep sequencing of the viral population (quasi-species) in both compartments
           (blood plasma and seminal plasma) before virological suppression has been achieved (i.e.
           at D0 and W12)

      Inclusion criteria :

        -  Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or
           indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a
           western blot profile compatible with ongoing seroconversion (incomplete western blot
           with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative
           test for HIV antibodies followed within 3 months by a positive HIV serology

        -  Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245
           mg/200 mg) initiated by the referee physician within a maximum of 15 days after
           diagnosis of PHI

        -  Genotypic sensitivity to TDF, FTC and DTG

        -  Patient with medical care insurance

      Exclusion criteria :

        -  Chronic infection

        -  Infection or co-infection with HIV-2

      Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients
      (exploratory study)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid
time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
description: Measure of HIV-RNA level in blood plasma and seminal fluid at each point and comparaison about the decay between both
measure: The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid
time frame: Day 0 and 48 weeks
measure: Comparison of dolutegravir concentration in blood plasma and seminal fluid
time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks
description: Measure of doltegravir concentration in blood and seminal fluid at each points and comparaison of the value between the 2 compartments
measure: Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved
time frame: Day 0 and 12 weeks
arm group label: Patient HIV primary infection
arm group type: Experimental
description: HIV primary infection Patient male receiving Dolutegravir
intervention type: Drug
intervention name: Dolutegravir
description: All patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples)
arm group label: Patient HIV primary infection
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Dolutegravir
sharing ipd: No