<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/NCT03011957</url>
  </required_header>
  <id_info>
    <org_study_id>2014P002489</org_study_id>
    <nct_id>NCT03011957</nct_id>
  </id_info>
  <brief_title>Biomarkers for Muscle Function and Aging in Chronic HIV Infection</brief_title>
  <acronym>MATCH</acronym>
  <official_title>Biomarkers for Muscle Function and Aging in Chronic HIV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy&#xD;
      (ART) and demographically matched uninfected adults to evaluate muscle and aging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MATCH is a non-randomized observational longitudinal study. We will recruit HIV infected&#xD;
      adults (50 to 65 years old) and demographically matched uninfected control subjects to be&#xD;
      followed for 4 years over the course of a 5 year study. The targeted age range of 50-65 is&#xD;
      chosen to evaluate aging HIV infected individuals at risk for early frailty in the United&#xD;
      States. All subjects will undergo blood draws and physical function assessment, and a subset&#xD;
      will undergo a CT scan of muscle and will have a muscle biopsy taken.&#xD;
&#xD;
      A substudy will be performed on a subgroup of HIV-infected and HIV-uninfected men from the&#xD;
      main cohort to measure daily physical activity by using an activity tracker.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2019</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>Inflammation at baseline and 3 years</measure>
    <time_frame>3 years</time_frame>
    <description>Inflammation at baseline and yearly for 3 years will be assessed by measuring circulating levels of inflammatory cytokines (e.g., CRP, IL6) and soluble monocyte/macrophage biomarkers (e.g., sCD14, sC163). These multiple measurements will be aggregated to arrive at one composite inflammatory score. Outcome will be assessed in association with HIV status and physical function.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>HIV positive viral load &lt; 200 copies/ml 50-65 years old CD4 &gt; 350 cells/ml Male or Female</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>HIV negative 50-65 years old CD4 &gt; 350 cells/ml Male or Female</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, muscle biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: 66 HIV+ (both men and women), 50 through 65 years of age, on effective&#xD;
        antiretroviral therapy (ART).&#xD;
&#xD;
        Group 2: 94 HIV- (both men and women), 50 through 65 years of age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group 1: HIV positive subjects&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  50-65 years old&#xD;
&#xD;
          -  On Antiretroviral therapy and an HIV viral load below 200 copies/ml&#xD;
&#xD;
          -  CD4 equal to or greater than 350 cells/mm3&#xD;
&#xD;
          -  Postmenopausal (women)&#xD;
&#xD;
          -  Lower extremity mobility sufficient to participate in functional assessment.&#xD;
&#xD;
        Group 2: HIV negative subjects Inclusion Criteria for Group 2 subjects&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  50-65 years old&#xD;
&#xD;
          -  Negative for HIV (based on an HIV antibody test at Study Visit 1)&#xD;
&#xD;
          -  Matched to Group 1 for sex (50% W, 50% M) and age (50 - 65yo)&#xD;
&#xD;
          -  Postmenopausal (women)&#xD;
&#xD;
          -  Lower extremity mobility sufficient to participate in functional assessment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria for Group 1 Subjects&#xD;
&#xD;
          -  Acute or serious illness within 60 days prior to entry&#xD;
&#xD;
          -  Use of pharmacologic doses of corticosteroids in the past 6 months.&#xD;
&#xD;
          -  Use of anabolic therapy in the past 6 months.&#xD;
&#xD;
          -  Lower extremity mobility insufficient to participate in functional assessment.&#xD;
&#xD;
          -  Current use (last 30 days) of anticoagulants or known bleeding disorder.&#xD;
&#xD;
        Exclusion Criteria for Group 2 subjects&#xD;
&#xD;
          -  Acute or serious illness within 60 days prior to entry&#xD;
&#xD;
          -  Use of pharmacologic doses of corticosteroids in the past 6 months&#xD;
&#xD;
          -  Use of anabolic therapy in the past 6 months&#xD;
&#xD;
          -  Lower extremity mobility insufficient to participate in functional assessment&#xD;
&#xD;
          -  Current use (last 30 days) of anticoagulants or known bleeding disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monty A Montano, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Womens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Tran T, Guardigni V, Pencina KM, Amato AA, Floyd M, Brawley B, Mozeleski B, McKinnon J, Woodbury E, Heckel E, Li Z, Storer T, Sax PE, Montano M. Atypical Skeletal Muscle Profiles in Human Immunodeficiency Virus-Infected Asymptomatic Middle-Aged Adults. Clin Infect Dis. 2018 Jun 1;66(12):1918-1927. doi: 10.1093/cid/cix1121.</citation>
    <PMID>29293942</PMID>
  </results_reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Monty Montano</investigator_full_name>
    <investigator_title>Director, Muscle and Aging Interventions</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only aggregate data will be made available through publication</ipd_description>
  </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/NCT03011957
org study id: 2014P002489
nct id: NCT03011957
lead sponsor: 
has dmc: No
MATCH is an observation study of HIV-infected adults on effective antiretroviral therapy
      (ART) and demographically matched uninfected adults to evaluate muscle and aging.
MATCH is a non-randomized observational longitudinal study. We will recruit HIV infected
      adults (50 to 65 years old) and demographically matched uninfected control subjects to be
      followed for 4 years over the course of a 5 year study. The targeted age range of 50-65 is
      chosen to evaluate aging HIV infected individuals at risk for early frailty in the United
      States. All subjects will undergo blood draws and physical function assessment, and a subset
      will undergo a CT scan of muscle and will have a muscle biopsy taken.

      A substudy will be performed on a subgroup of HIV-infected and HIV-uninfected men from the
      main cohort to measure daily physical activity by using an activity tracker.
observational model: Cohort
time perspective: Prospective
measure: Inflammation at baseline and 3 years
time frame: 3 years
description: Inflammation at baseline and yearly for 3 years will be assessed by measuring circulating levels of inflammatory cytokines (e.g., CRP, IL6) and soluble monocyte/macrophage biomarkers (e.g., sCD14, sC163). These multiple measurements will be aggregated to arrive at one composite inflammatory score. Outcome will be assessed in association with HIV status and physical function.
arm group label: Group 1
description: HIV positive viral load < 200 copies/ml 50-65 years old CD4 > 350 cells/ml Male or Female
arm group label: Group 2
description: HIV negative 50-65 years old CD4 > 350 cells/ml Male or Female
Blood, muscle biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Monty A Montano, PhD
role: Principal Investigator
affiliation: Brigham and Womens Hospital
facility: 
country: United States
citation: Tran T, Guardigni V, Pencina KM, Amato AA, Floyd M, Brawley B, Mozeleski B, McKinnon J, Woodbury E, Heckel E, Li Z, Storer T, Sax PE, Montano M. Atypical Skeletal Muscle Profiles in Human Immunodeficiency Virus-Infected Asymptomatic Middle-Aged Adults. Clin Infect Dis. 2018 Jun 1;66(12):1918-1927. doi: 10.1093/cid/cix1121.
PMID: 29293942
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Monty Montano
investigator title: Director, Muscle and Aging Interventions
mesh term: HIV Infections
sharing ipd: No
ipd description: Only aggregate data will be made available through publication