<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/NCT04460924</url>
  </required_header>
  <id_info>
    <org_study_id>ARTiBIOME: Observational study</org_study_id>
    <nct_id>NCT04460924</nct_id>
  </id_info>
  <brief_title>ARTiBIOME: Observational Study on the Effect of HIV and ART on Gut Microbiome</brief_title>
  <official_title>ARTiBIOME: Effect of HIV and ART on Gut Microbiome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Antiretroviral treatment for HIV has allowed patients to have undetectable viral load&#xD;
      indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with&#xD;
      increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of&#xD;
      intestinal bacterial populations. However, little is known on the impact of the&#xD;
      antiretroviral treatment on this population and very few studies have evaluated these&#xD;
      alterations.&#xD;
&#xD;
      The aim of this study is to study microbiome on healthy patients and HIV-infected patients&#xD;
      exposed to antiretroviral treatment with integrase strand transfer inhibitors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">March 1, 2023</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Alpha diversity changes of fecal microbiota composition</measure>
    <time_frame>Baseline and 1 month, 3 months, 12 months</time_frame>
    <description>Alpha diversity changes of fecal microbiota composition between study groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beta diversity changes of fecal microbiota composition</measure>
    <time_frame>Baseline and 1 month, 3 months, 12 months</time_frame>
    <description>Beta diversity changes of fecal microbiota composition between study groups</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>MSM HIV-uninfected and ART naïve</arm_group_label>
    <description>Men who have sex with men without HIV infection, not receiving ART</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MSM HIV-infected starting ART</arm_group_label>
    <description>Men who have sex with men with HIV infection, starting ART</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MSM HIV-infected on ART with &gt;500 CD4 Tcells</arm_group_label>
    <description>Men who have sex with men with HIV infection, on ART and with &gt;500 CD4 T cells/uL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MSM HIV-infected on ART with &lt;350 CD4 Tcells</arm_group_label>
    <description>Men who have sex with men with HIV infection, on ART and with &lt;350 CD4 T cells/uL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MSM HIV negative patients starting PEP with INST</arm_group_label>
    <description>Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Integrase strand transfer inhibitors</intervention_name>
    <description>Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment</description>
    <arm_group_label>MSM HIV negative patients starting PEP with INST</arm_group_label>
    <arm_group_label>MSM HIV-infected on ART with &lt;350 CD4 Tcells</arm_group_label>
    <arm_group_label>MSM HIV-infected on ART with &gt;500 CD4 Tcells</arm_group_label>
    <arm_group_label>MSM HIV-infected starting ART</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Feces&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will compare 20 MSM HIV negative patients starting PEP with INSTI with:&#xD;
&#xD;
          -  20 MSM HIV-uninfected and ART naïve (A)&#xD;
&#xD;
          -  20 MSM HIV-infected starting ART (B)&#xD;
&#xD;
          -  20 MSM HIV-infected on ART with &gt;500 CD4 Tcells ( C )&#xD;
&#xD;
          -  20 MSM HIV-infected on ART with &lt;350 CD4 Tcells (D) (the study population has been&#xD;
             restricted to MSM given the strong influence of sexual orientation on the microbiota&#xD;
             composition&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Willing to sign consent form&#xD;
&#xD;
          -  Men with an age &gt;18 years&#xD;
&#xD;
          -  Engagement in insertive or receptive anal intercourse with another men&#xD;
&#xD;
             *Exclusion criteria:&#xD;
&#xD;
          -  Previous history of ART exposure&#xD;
&#xD;
          -  Use of antibiotics in the past 3 months&#xD;
&#xD;
          -  Previous history of inflammatory bowel disease, autoimmune disease or cirrhosis.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal and Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Integrase Inhibitors</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/NCT04460924
org study id: ARTiBIOME: Observational study
nct id: NCT04460924
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Antiretroviral treatment for HIV has allowed patients to have undetectable viral load
      indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with
      increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of
      intestinal bacterial populations. However, little is known on the impact of the
      antiretroviral treatment on this population and very few studies have evaluated these
      alterations.

      The aim of this study is to study microbiome on healthy patients and HIV-infected patients
      exposed to antiretroviral treatment with integrase strand transfer inhibitors.
observational model: Case-Control
time perspective: Prospective
measure: Alpha diversity changes of fecal microbiota composition
time frame: Baseline and 1 month, 3 months, 12 months
description: Alpha diversity changes of fecal microbiota composition between study groups
measure: Beta diversity changes of fecal microbiota composition
time frame: Baseline and 1 month, 3 months, 12 months
description: Beta diversity changes of fecal microbiota composition between study groups
arm group label: MSM HIV-uninfected and ART naïve
description: Men who have sex with men without HIV infection, not receiving ART
arm group label: MSM HIV-infected starting ART
description: Men who have sex with men with HIV infection, starting ART
arm group label: MSM HIV-infected on ART with >500 CD4 Tcells
description: Men who have sex with men with HIV infection, on ART and with >500 CD4 T cells/uL
arm group label: MSM HIV-infected on ART with <350 CD4 Tcells
description: Men who have sex with men with HIV infection, on ART and with <350 CD4 T cells/uL
arm group label: MSM HIV negative patients starting PEP with INST
description: Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir
intervention type: Drug
intervention name: Integrase strand transfer inhibitors
description: Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment
arm group label: MSM HIV negative patients starting PEP with INST
arm group label: MSM HIV-infected on ART with <350 CD4 Tcells
arm group label: MSM HIV-infected on ART with >500 CD4 Tcells
arm group label: MSM HIV-infected starting ART
Feces
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Integrase Inhibitors
sharing ipd: No