<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/NCT01679067</url>
  </required_header>
  <id_info>
    <org_study_id>GALT-HIV</org_study_id>
    <nct_id>NCT01679067</nct_id>
  </id_info>
  <brief_title>Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients</brief_title>
  <official_title>Phase IV Longitudinal Study of Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients Before and During Antiretroviral Therapy (ART)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clara Lehmann</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cologne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people&#xD;
      are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more&#xD;
      likely to be diagnosed with opportunistic infections, their risk of death is higher and their&#xD;
      rate of immunological improvement is slower (Mussini C et al., 2008). These patients often&#xD;
      present a real challenge due to their advanced clinical status (Borghi V et al., 2008).&#xD;
      Unfortunately, little is known about the clinical presentation of these patients, their&#xD;
      responses to antiretroviral treatment and especially about the changes in the adaptive and&#xD;
      innate immunity of the GALT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator proposes to evaluate the virological, immunological and clinical outcomes of&#xD;
      ART in HIV-1 infected 'late presenters'. The investigator further wants to investigate the&#xD;
      longitudinal dynamics of the innate and adaptive immunity restoration in the GALT and&#xD;
      peripheral blood of HIV infected patients under ART. In particular the investigators want to&#xD;
      longitudinally assess DCs, NK-cells, CD4+ T-cells und CD45RO+-T-cells as well as the levels&#xD;
      of IFNγ, IFNα, TNFα, and IL-12 in the GALT and peripheral blood by flow cytometry and by&#xD;
      real-time PCR and correlate these data with laboratory and clinical parameters.&#xD;
&#xD;
      The investigators expect that this longitudinal study and experiments outlined in the&#xD;
      protocol will provide valuable information about several important issues of the clinical&#xD;
      outcome of patients under ART as well as understanding immunopathology during HIV-infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>restoration of CD4 + T-cells in the GALT with ART</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Function of Dendritic Cells (DC) in the GALT with ART</measure>
    <time_frame>6 months</time_frame>
    <description>Functional characterization of DCs (IFNγ, IFNα) of DCs in the GALT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional characterization of NK-cells in the GALT with ART</measure>
    <time_frame>6 months</time_frame>
    <description>Functional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>HIV Infection</condition>
  <arm_group>
    <arm_group_label>HIV-GALT</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colonoscopy with endoscopic biopsies</intervention_name>
    <arm_group_label>HIV-GALT</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Endoscopic biopsies, PBMC&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        prospective longitudinal non- controlled phase IV study, 30 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented HIV infection&#xD;
&#xD;
          -  Patients naive to antiretroviral treatment&#xD;
&#xD;
          -  Age older than 18 years&#xD;
&#xD;
          -  Indication for initiation of ART&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on antiretroviral treatment&#xD;
&#xD;
          -  No informed consent&#xD;
&#xD;
          -  Estimated life expectancy &lt;1 year&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Cologne</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>January 12, 2016</last_update_submitted>
  <last_update_submitted_qc>January 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>Clara Lehmann</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>GALT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
  </condition_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/NCT01679067
org study id: GALT-HIV
nct id: NCT01679067
lead sponsor: 
collaborator: 
has dmc: No
To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people
      are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more
      likely to be diagnosed with opportunistic infections, their risk of death is higher and their
      rate of immunological improvement is slower (Mussini C et al., 2008). These patients often
      present a real challenge due to their advanced clinical status (Borghi V et al., 2008).
      Unfortunately, little is known about the clinical presentation of these patients, their
      responses to antiretroviral treatment and especially about the changes in the adaptive and
      innate immunity of the GALT.
The investigator proposes to evaluate the virological, immunological and clinical outcomes of
      ART in HIV-1 infected 'late presenters'. The investigator further wants to investigate the
      longitudinal dynamics of the innate and adaptive immunity restoration in the GALT and
      peripheral blood of HIV infected patients under ART. In particular the investigators want to
      longitudinally assess DCs, NK-cells, CD4+ T-cells und CD45RO+-T-cells as well as the levels
      of IFNγ, IFNα, TNFα, and IL-12 in the GALT and peripheral blood by flow cytometry and by
      real-time PCR and correlate these data with laboratory and clinical parameters.

      The investigators expect that this longitudinal study and experiments outlined in the
      protocol will provide valuable information about several important issues of the clinical
      outcome of patients under ART as well as understanding immunopathology during HIV-infection.
observational model: Cohort
time perspective: Prospective
measure: restoration of CD4 + T-cells in the GALT with ART
time frame: 6 months
measure: Function of Dendritic Cells (DC) in the GALT with ART
time frame: 6 months
description: Functional characterization of DCs (IFNγ, IFNα) of DCs in the GALT
measure: Functional characterization of NK-cells in the GALT with ART
time frame: 6 months
description: Functional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART
arm group label: HIV-GALT
intervention type: Procedure
intervention name: colonoscopy with endoscopic biopsies
arm group label: HIV-GALT
Endoscopic biopsies, PBMC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Cologne
investigator full name: Clara Lehmann
investigator title: principal investigator
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome