<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/NCT03009032</url>
  </required_header>
  <id_info>
    <org_study_id>14/016</org_study_id>
    <nct_id>NCT03009032</nct_id>
  </id_info>
  <brief_title>Synbiotics in Advanced HIV Infection</brief_title>
  <acronym>PROMALTIA</acronym>
  <official_title>Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease</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>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario 12 de Octubre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital San Pedro de Logroño</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital del Mar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a&#xD;
      greater risk of clinical progression. Gut bacteria metabolism appears to impact immune&#xD;
      recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and&#xD;
      probiotics seem to exert immunological effects, the clinical implications in this key&#xD;
      population remain unknown. This is a pilot multicenter randomized placebo-controlled, double&#xD;
      blind clinical trial in HIV-infected ART-naive subjects with &lt;350 CD4 T cells/mm3 or AIDS.&#xD;
      Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341&#xD;
      or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be&#xD;
      safety and immunological recovery. Secondary outcomes will include changes in fecal&#xD;
      microbiota structure and plasma inflammatory markers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>From baseline through week 48</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in CD4+ T cell counts/uL</measure>
    <time_frame>From baseline through week 48</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in CD8+ T cell counts/uL</measure>
    <time_frame>From baseline through week 48</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in CD4/CD8 ratio</measure>
    <time_frame>From baseline through week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiota composition: alpha-diversity</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota composition: Unifrac distances</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota composition: Canberra distances</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma soluble CD14 levels</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma hs-CRP levels</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma IFABP levels</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma lipoteichoic acid levels</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma kynurenine/tryptophan ratio</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in percentage of HLADR+/CD38+ T cells</measure>
    <time_frame>From baseline through week 48</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>HIV Infection Asymptomatic</condition>
  <arm_group>
    <arm_group_label>PMT25341</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLACEBO</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Lactose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>PMT25341</intervention_name>
    <arm_group_label>PMT25341</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Lactose</description>
    <arm_group_label>PLACEBO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-infected ART-naive subjects with &lt;350 CD4 T cells/mm3 or AIDS&#xD;
&#xD;
          -  Initiating ART with any first-line regimen recommended in the Spanish GESIDA National&#xD;
             Guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Type 1 or 2 diabetes&#xD;
&#xD;
          -  End-stage renal disease&#xD;
&#xD;
          -  Lactose intolerance&#xD;
&#xD;
          -  Use of immunomodulatory drugs&#xD;
&#xD;
          -  Neutrophil count &lt;750cells/uL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</investigator_affiliation>
    <investigator_full_name>Sergio Serrano-Villar</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>immunologic recovery</keyword>
  <keyword>microbiota</keyword>
  <keyword>prebiotics</keyword>
  <keyword>probiotics</keyword>
  <keyword>synbiotics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
  </condition_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/NCT03009032
org study id: 14/016
nct id: NCT03009032
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a
      greater risk of clinical progression. Gut bacteria metabolism appears to impact immune
      recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and
      probiotics seem to exert immunological effects, the clinical implications in this key
      population remain unknown. This is a pilot multicenter randomized placebo-controlled, double
      blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS.
      Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341
      or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be
      safety and immunological recovery. Secondary outcomes will include changes in fecal
      microbiota structure and plasma inflammatory markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: From baseline through week 48
measure: Changes in CD4+ T cell counts/uL
time frame: From baseline through week 48
measure: Changes in CD8+ T cell counts/uL
time frame: From baseline through week 48
measure: Changes in CD4/CD8 ratio
time frame: From baseline through week 48
measure: Microbiota composition: alpha-diversity
time frame: From baseline through week 48
measure: Microbiota composition: Unifrac distances
time frame: From baseline through week 48
measure: Microbiota composition: Canberra distances
time frame: From baseline through week 48
measure: Changes in plasma soluble CD14 levels
time frame: From baseline through week 48
measure: Changes in plasma hs-CRP levels
time frame: From baseline through week 48
measure: Changes in plasma IFABP levels
time frame: From baseline through week 48
measure: Changes in plasma lipoteichoic acid levels
time frame: From baseline through week 48
measure: Changes in plasma kynurenine/tryptophan ratio
time frame: From baseline through week 48
measure: Changes in percentage of HLADR+/CD38+ T cells
time frame: From baseline through week 48
arm group label: PMT25341
arm group type: Experimental
description: A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids
arm group label: PLACEBO
arm group type: Placebo Comparator
description: Lactose
intervention type: Dietary Supplement
intervention name: PMT25341
arm group label: PMT25341
intervention type: Dietary Supplement
intervention name: Placebo
description: Lactose
arm group label: PLACEBO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
investigator full name: Sergio Serrano-Villar
investigator title: MD, PhD
mesh term: Infections
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
sharing ipd: No