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/NCT05973825</url>
    </required_header>
    <id_info>
      <org_study_id>ONZ-2023-0154</org_study_id>
      <nct_id>NCT05973825</nct_id>
    </id_info>
    <brief_title>Immuno-virological Evaluation of Persons Living With HIV (PLWH)</brief_title>
    <official_title>Immuno-virological Evaluation of Persons Living With HIV (PLWH) Who Initiated Anti-retroviral Treatment (ART) During Acute HIV Infection and of PLWH on Long Term ART</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Ghent</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Vrije Universiteit Brussel</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre Hospitalier Universitaire Saint Pierre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre Hospitalier Universitaire de Liege</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universitair Ziekenhuis Brussel</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Université Libre de Bruxelles</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>KU Leuven</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Ghent</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a dual arm (arm 1 and arm 2) multi-centric non-randomized (prospective) study.&#xD;
  &#xD;
        Two new multicentric cohorts will be set up in 4 Belgian HIV reference centers (UZ Gent, UZ&#xD;
        Brussel, University Hospital Liege and St. Pierre Hospital Brussels): cohort 1 will comprise&#xD;
        PLWH in whom ART was initiated during acute HIV infection minimum 3 years ago but no more&#xD;
        than 10 years ago (short-term ART cohort); cohort 2 will comprise PLWH on ART since &gt;20 years&#xD;
        (long-term ART cohort). Participants will be included based on suppressed viremia and&#xD;
        uninterrupted ART since initiation. Participants will undergo one blood sampling and one&#xD;
        leukapheresis. In and exclusion criteria are described below.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This project aims to gain new knowledge and insights into the viral reservoir establishment&#xD;
        and HIV Latency as well as to develop new powerful tools to study latency reversal, that will&#xD;
        ultimately contribute to research into an HIV curative treatment.&#xD;
  &#xD;
        The study objectives are&#xD;
  &#xD;
          -  To collect and store state of the art peripheral blood samples (60 vials of 50 X106&#xD;
             PBMC's) from two patient cohorts, 10 acute seroconverters and 10 long-term ART-treated&#xD;
             patients .&#xD;
  &#xD;
          -  To characterize and compare the latent reservoir in blood samples from both cohorts as&#xD;
             for the proviral genome, transcriptome, epigenome and T cell receptor level&#xD;
  &#xD;
          -  To perform an immunological profiling of infected cells.&#xD;
  &#xD;
          -  To evaluate available drugs that induce either a block-and-lock or a shock-and-kill in&#xD;
             in vitro interventions using blood samples from both cohorts&#xD;
  &#xD;
          -  To accelerate the negative selection of transcriptionally competent proviruses in vitro&#xD;
             and determine the role of the different determinants.&#xD;
  &#xD;
          -  To make all data available for the different partners and integrate all data acquired.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">July 12, 2029</completion_date>
    <primary_completion_date type="Anticipated">July 12, 2026</primary_completion_date>
    <phase>N/A</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Information on virological aspects of people on long term ART versus people treated during recent infection</measure>
      <time_frame>3 years</time_frame>
      <description>Intact proviral deoxyribonucleic acid (DNA) assay quantified by digital Polymerase Chain Reaction (pcr)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>HIV-1-infection</condition>
    <condition>HIV Seropositivity</condition>
    <arm_group>
      <arm_group_label>Immuno-virological evaluation of persons living with HIV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Leucapheresis will be performed in HIV positive people making white blood cells available for in depth virological and immunological evaluation</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Leucapheresis</intervention_name>
      <description>leucapheresis is a procedure in which a large amount of blood cells are obtained by an apheresis procedure</description>
      <arm_group_label>Immuno-virological evaluation of persons living with HIV</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Cohort 1: short-term ART cohort&#xD;
  &#xD;
            -  Documented HIV-1 infection&#xD;
  &#xD;
            -  Able and willing to provide written informed consent&#xD;
  &#xD;
            -  Age = or &gt;18 years and &lt; 80 years&#xD;
  &#xD;
            -  ART started during a documented recent HIV-1 infection (acute HIV infection, defined&#xD;
               as:&#xD;
  &#xD;
                 -  Clinical symptoms of acute seroconversion and incomplete Western Blot, or&#xD;
  &#xD;
                 -  Negative screening test within the past 6 months and incomplete Western Blot, or&#xD;
  &#xD;
                 -  Risk contact within the &lt;3 months and presumable primo-infection with or without&#xD;
                    clinical symptoms and incomplete Western Blot.&#xD;
  &#xD;
            -  Being on ART since minimum 2 years and maximum 10 years&#xD;
  &#xD;
            -  Participants should have had a routine plasma viral load measurement at least once a&#xD;
               year.&#xD;
  &#xD;
            -  Viral load &lt; 40 or &lt;50 copies/ml determined by the assay (used in the local centers)&#xD;
               for at least 3 years (one blip &lt; 200 copies/ml is allowed)&#xD;
  &#xD;
            -  Ability and willingness to have blood samples collected and stored for 20 years and&#xD;
               used for various research purposes.&#xD;
  &#xD;
            -  Patients with HIV-1 subtype B are preferred for inclusion (as most of the complex&#xD;
               assays are subtype B specific). However, if the investigators do not reach our target&#xD;
               of 10 participants, patients infected with other subtypes will be allowed to enter the&#xD;
               study. (Primers will subsequently be adapted to the patient-specific proviral&#xD;
               sequences).&#xD;
  &#xD;
          Cohort 2: long-term ART cohort&#xD;
  &#xD;
            -  Documented HIV-1 infection&#xD;
  &#xD;
            -  Able and willing to provide written informed consent&#xD;
  &#xD;
            -  Age = or &gt;18 years and &lt; 80 years&#xD;
  &#xD;
            -  Being on ART since at least 20 years&#xD;
  &#xD;
            -  ART should not have been started during a documented recent HIV-1 infection (acute HIV&#xD;
               infection), defined as:&#xD;
  &#xD;
                 -  Clinical symptoms of acute seroconversion and incomplete Western Blot or&#xD;
  &#xD;
                 -  Negative screening test within the past 6 months and incomplete Western Blot or&#xD;
  &#xD;
                 -  Risk contact within &lt;3 months and presumable primo-infection with or without&#xD;
                    clinical symptoms and incomplete Western Blot.&#xD;
  &#xD;
            -  Patients should have had a routine plasma viral load measurement at least once a year.&#xD;
  &#xD;
            -  Routine plasma viral load &lt; 40 or &lt;50 copies/ml determined by the assay used in the&#xD;
               local centres for at least 20 years (one blip &lt; 200 copies/ml is allowed if it&#xD;
               occurred &gt;10 years ago)&#xD;
  &#xD;
            -  Ability and willingness to have blood samples collected and stored for 20 years and&#xD;
               used for various research purposes.&#xD;
  &#xD;
            -  Participants with HIV-1 subtype B are preferred for inclusion (as most of the complex&#xD;
               assays are subtype B specific). However, if the investigators do not reach our target&#xD;
               of 10 participants, patients infected with other subtypes will be allowed to enter the&#xD;
               study. (Primers will subsequently be adapted to the patient-specific proviral&#xD;
               sequences).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous or current history of opportunistic infection (AIDS defining events as&#xD;
               defined in category C of the Centers for Disease Control and Prevention (CDC) clinical&#xD;
               classification), consisting of chronic HIV-1 infection.&#xD;
  &#xD;
            -  Evidence of active Hepatitis B-virus (HBV) infection (Hepatitis B surface antigen&#xD;
               positive or HBV viral load positive in the past and no evidence of subsequent&#xD;
               seroconversion (= HBV antigen or viral load negative and positive HBV surface&#xD;
               antibody).&#xD;
  &#xD;
            -  Evidence of active HCV infection (HCV antibody positive result within 60 days prior to&#xD;
               study entry with positive HCV viral load or, if the HCV antibody result is negative, a&#xD;
               positive HCV RNA result within 60 days prior to study entry).&#xD;
  &#xD;
            -  Current or known history of cardiomyopathy or significant ischemic or cerebrovascular&#xD;
               disease.&#xD;
  &#xD;
            -  Current cancer.&#xD;
  &#xD;
            -  History of HIV-related thrombocytopenia.&#xD;
  &#xD;
            -  Pregnancy or breastfeeding.&#xD;
  &#xD;
            -  Any condition, including preexisting psychiatric and psychological disorders, which&#xD;
               will in the opinion of the investigator interfere with the trial conduct or safety of&#xD;
               the participant.&#xD;
  &#xD;
            -  Abnormal results of standard of care laboratory tests:&#xD;
  &#xD;
                 1. Confirmed haemoglobin &lt;11g/dl for women and &lt;12 g/dl for men&#xD;
  &#xD;
                 2. Confirmed platelet count &lt;100 000/µl *&#xD;
  &#xD;
                 3. Confirmed neutrophil count &lt;1000/μl&#xD;
  &#xD;
                 4. Confirmed Aspartate aminotransferase (AST) and/or alanine aminotransferase&#xD;
                    (ALT)&gt;10x upper limit of normal (ULN)&#xD;
  &#xD;
            -  Active drug or alcohol use or dependence that, in the opinion of the site&#xD;
               investigator, would interfere with adherence to study requirements.&#xD;
  &#xD;
            -  Acute or serious illness, in the opinion of the site investigator, requiring systemic&#xD;
               treatment and/or hospitalization within 60 days prior to entry.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Linos vandekerckhove</last_name>
      <role>Principal Investigator</role>
      <affiliation>UZ Gent</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Linos Vandekerckhove</last_name>
      <phone>+3293323398</phone>
      <email>linos.vandekerckhove@ugent.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>UZ Gent</name>
        <address>
          <city>Gent</city>
          <state>Oost-Vlaanderen</state>
          <zip>9000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Linos Vandekerckhove</last_name>
        <phone>09333398</phone>
        <email>linos.vandekerckhove@ugent.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Ghent</investigator_affiliation>
      <investigator_full_name>Algemene Inwendige Ziekten</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>HIV Seropositivity</mesh_term>
    </condition_browse>
    <!-- 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/NCT05973825
  org study id: ONZ-2023-0154
  nct id: NCT05973825
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a dual arm (arm 1 and arm 2) multi-centric non-randomized (prospective) study.
  
        Two new multicentric cohorts will be set up in 4 Belgian HIV reference centers (UZ Gent, UZ
        Brussel, University Hospital Liege and St. Pierre Hospital Brussels): cohort 1 will comprise
        PLWH in whom ART was initiated during acute HIV infection minimum 3 years ago but no more
        than 10 years ago (short-term ART cohort); cohort 2 will comprise PLWH on ART since >20 years
        (long-term ART cohort). Participants will be included based on suppressed viremia and
        uninterrupted ART since initiation. Participants will undergo one blood sampling and one
        leukapheresis. In and exclusion criteria are described below.
  This project aims to gain new knowledge and insights into the viral reservoir establishment
        and HIV Latency as well as to develop new powerful tools to study latency reversal, that will
        ultimately contribute to research into an HIV curative treatment.
  
        The study objectives are
  
          -  To collect and store state of the art peripheral blood samples (60 vials of 50 X106
             PBMC's) from two patient cohorts, 10 acute seroconverters and 10 long-term ART-treated
             patients .
  
          -  To characterize and compare the latent reservoir in blood samples from both cohorts as
             for the proviral genome, transcriptome, epigenome and T cell receptor level
  
          -  To perform an immunological profiling of infected cells.
  
          -  To evaluate available drugs that induce either a block-and-lock or a shock-and-kill in
             in vitro interventions using blood samples from both cohorts
  
          -  To accelerate the negative selection of transcriptionally competent proviruses in vitro
             and determine the role of the different determinants.
  
          -  To make all data available for the different partners and integrate all data acquired.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Information on virological aspects of people on long term ART versus people treated during recent infection
  time frame: 3 years
  description: Intact proviral deoxyribonucleic acid (DNA) assay quantified by digital Polymerase Chain Reaction (pcr)
  arm group label: Immuno-virological evaluation of persons living with HIV
  arm group type: Experimental
  description: Leucapheresis will be performed in HIV positive people making white blood cells available for in depth virological and immunological evaluation
  intervention type: Procedure
  intervention name: Leucapheresis
  description: leucapheresis is a procedure in which a large amount of blood cells are obtained by an apheresis procedure
  arm group label: Immuno-virological evaluation of persons living with HIV
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Linos vandekerckhove
  role: Principal Investigator
  affiliation: UZ Gent
  last name: Linos Vandekerckhove
  phone: +3293323398
  email: linos.vandekerckhove@ugent.be
  facility: 
  contact: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Ghent
  investigator full name: Algemene Inwendige Ziekten
  investigator title: Professor
  mesh term: Infections
  mesh term: HIV Seropositivity