<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/NCT02975258</url>
  </required_header>
  <id_info>
    <org_study_id>PRO15070529</org_study_id>
    <secondary_id>1R56HL128134-01A1</secondary_id>
    <nct_id>NCT02975258</nct_id>
  </id_info>
  <brief_title>Adiposity and Airway Inflammation in HIV-Associated Airway Disease</brief_title>
  <acronym>SHOP</acronym>
  <official_title>Adiposity and Airway Inflammation in HIV-Associated Airway Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this study are to 1) examine the relationships among inflammation, obesity, and&#xD;
      asthma in people with HIV and 2) to test if special subtypes of cells or markers are present&#xD;
      in the blood and lungs of people with HIV with asthma compared to those without asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study involves the recruitment of participant population and the use of data&#xD;
      from the existing research study cohorts that have been recruited and have provided informed&#xD;
      consent for participation. Participants meet all inclusion/exclusion criteria will be&#xD;
      enrolled into the study. Participants in the existing research study cohorts have pulmonary&#xD;
      function testing, chest CT scans, and blood draws at each study visit which occurs every 18&#xD;
      months for 3 visits. Some of the study procedures may not be repeated if they were done as&#xD;
      part of other research projects.&#xD;
&#xD;
        1. Main study visit&#xD;
&#xD;
           The following research procedures may be performed over the course of one or more visits&#xD;
           to accommodate scheduling needs. The study visit will take place at the Montefiore&#xD;
           Clinical and Translational Research Center and the University of Pittsburgh Asthma&#xD;
           Institute in the University of Pittsburgh Medical Center - Montefiore Hospital and may&#xD;
           take up to 4 hours to complete.&#xD;
&#xD;
             -  Informed consent&#xD;
&#xD;
             -  Medical history review and demographics&#xD;
&#xD;
             -  Review of inclusion/exclusion criteria&#xD;
&#xD;
             -  Physical examination to include vital signs, weight and height, waist, hip, and&#xD;
                thigh circumferences.&#xD;
&#xD;
             -  Urine pregnancy test for female of childbearing potential&#xD;
&#xD;
             -  Asthma-focused and quality of life questionnaire&#xD;
&#xD;
             -  Exhaled Nitric Oxide (eNO) measurement&#xD;
&#xD;
             -  Spirometry&#xD;
&#xD;
             -  Methacholine challenge testing - will not need to be repeated if the participant&#xD;
                had done this as part of another study in the past 6 months.&#xD;
&#xD;
             -  Chest/Abdominal CT scans (If the participant has had the Chest CT scan done within&#xD;
                6 months as part of other research study, they will not be repeated for study&#xD;
                purposes. Only the Abdominal CT will be performed)&#xD;
&#xD;
             -  Research blood sampling for biomarker analyses - some of this blood will also be&#xD;
                used for pre-bronchoscopy testing in the case that the participant qualifies and is&#xD;
                interested in undergoing part 2, the bronchoscopy visit.&#xD;
&#xD;
             -  Adipose tissue biopsy (Fat Biopsy): performed on participants with a BMI≥25). This&#xD;
                will be repeated if done previously because testing to be done on the fat will be&#xD;
                different than what had been tested on the fat previously.&#xD;
&#xD;
        2. Optional sub-study&#xD;
&#xD;
      On a separate visit, only a subset of 60 selected participants will be asked to undergo the&#xD;
      following procedures to obtain additional lung biological samples. This visit is optional for&#xD;
      participants who are willing to participate in the bronchoscopy portion. The investigators&#xD;
      will try to recruit an equal number (n=15 per group) of obese asthmatics, obese&#xD;
      non-asthmatics, non-obese asthmatics, and non-obese non-asthmatics. The visit will take place&#xD;
      in the Montefiore Clinical Translational Research Center (MUH-CTRC). The bronchoscopy&#xD;
      procedure will take about 30-45 minutes, but the preparation and recovery time will usually&#xD;
      make the visit about 4-8 hours total.&#xD;
&#xD;
      Participants will be expected to fast for 8 hours prior to the bronchoscopy procedure and&#xD;
      refrain from drinking any liquids the day of the procedure. Participants may take their usual&#xD;
      medicines with sips of water.&#xD;
&#xD;
      • Clinical laboratory testing to include complete blood count/differential/platelet count,&#xD;
      prothrombin time/partial thromboplastin time, international Normalized Ratio, blood urea&#xD;
      nitrogen, and creatinine prior to bronchoscopy. If the patient refuses the first blood draw,&#xD;
      the sample is inadequate, or the labs were run more than 30 days prior to the bronchoscopy&#xD;
      visit, a second blood sample of up to 1 tablespoon may be drawn prior to the bronchoscopy&#xD;
      procedure to ensure the patient is healthy enough for the procedure.&#xD;
&#xD;
      If Methacholine challenge was done more than 30 days prior to the visit two date, pulmonary&#xD;
      function tests will be repeated.&#xD;
&#xD;
        -  Oral Wash: participants will be asked to gargle with salt water for 1 minute and then&#xD;
           spit into a container to provide a sample of approximately 10mls (2 teaspoons) at this&#xD;
           study visit.&#xD;
&#xD;
        -  Tongue Scraping: tongue blade or similar object will be used to scrape the participant's&#xD;
           tongue. This sample will be used to determine what bacteria are on the participant's&#xD;
           tongue. This procedure should only take minutes and is not painful.&#xD;
&#xD;
        -  Participants will then rinse with 10cc's of Listerine. This is to assure that there are&#xD;
           no bacteria left behind in the participant's mouth prior to the bronchoscopy.&#xD;
&#xD;
        -  Bronchoscopy with bronchoalveolar lavage (BAL), endobronchial brushing and biopsy&#xD;
&#xD;
      Under local anesthesia, participants will undergo bronchoscopy with BAL for microbiologic&#xD;
      specimens. A light intravenous anesthetic will be titrated to provide participant comfort if&#xD;
      necessary. Vitals signs will be monitored continuously before, during, and after the&#xD;
      procedure. This procedure consists of 3 stages.&#xD;
&#xD;
        1. Pulmonary Lavage: During pulmonary lavage, five 50 mL washes of sterile salt-water&#xD;
           solution will be injected through the bronchoscope. Fluid will be collected with gentle&#xD;
           suctioning for research studies.&#xD;
&#xD;
        2. Bronchial Brushing: A small brush will be introduced through the bronchoscope and gently&#xD;
           rubbed over a very small part of the surface of the lungs. Approximately 10 brushes will&#xD;
           be performed to collect epithelial cells.&#xD;
&#xD;
        3. Endobronchial Biopsy: While the bronchoscope is inserted, another small instrument will&#xD;
           be passed through the bronchoscope to take small samples (biopsies) of tissue from the&#xD;
           walls of the airways. Up to 5 samples may be taken during this procedure.&#xD;
&#xD;
      Following the bronchoscopy procedure, participants will be closely monitored in the&#xD;
      bronchoscopy recovery area or return to the CTRC. Rarely, the participant's asthma may worsen&#xD;
      during or after the procedure. Appropriate medical treatments or overnight observation will&#xD;
      be provided if needed. Participants will not be allowed to drive home after the bronchoscopy.&#xD;
      This is because the sedatives used during the procedure may decrease driving ability. The&#xD;
      investigators will ask for the contact name and number of the person that will pick up the&#xD;
      participant after the bronchoscopy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Adverse interaction of adiposity and HIV-associated inflammation in asthma susceptibility and airway remodeling in HIV</measure>
    <time_frame>Baseline</time_frame>
    <description>The investigator will test association of adiposity (body mass index, waist circumference, computed tomography (CT)-measured visceral adiposity) with prevalence of asthma and longitudinal progression of airway obstruction. the blood and lungs of people with HIV with asthma compared to those without asthma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between leptin and asthma susceptibility in HIV.</measure>
    <time_frame>Baseline</time_frame>
    <description>Leptin, an obesity-related inflammatory marker, levels will be compared between HIV+ asthmatics and non-asthmatics and correlated with airway remodeling on endobronchial biopsy and CT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between adiponectin, asthma susceptibility, and airway remodeling in HIV.</measure>
    <time_frame>Baseline</time_frame>
    <description>Adiponectin, an obesity-related inflammatory marker, levels will be compared between HIV+ asthmatics and non-asthmatics and correlated with airway remodeling on endobronchial biopsy and CT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adipose tissue-related inflammation contributes to asthma susceptibility and airway remodeling in HIV.</measure>
    <time_frame>Baseline</time_frame>
    <description>Using abdominal adipose tissue biopsies, the investigators will phenotype adipose-specific inflammatory cells and pathways and determine associations with asthma, airway remodeling, and longitudinal progression of airway obstruction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low L-arginine increases asthma risk and airway remodeling in HIV.</measure>
    <time_frame>Baseline</time_frame>
    <description>The investigator will measure L-arginine in serum and bronchoalveolar lavage samples to compare levels between HIV+ asthmatics and non-asthmatics and correlate L-arginine with CT and biopsy measures of airway remodeling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low ADMA increases asthma risk and airway remodeling in HIV.</measure>
    <time_frame>Baseline</time_frame>
    <description>The investigator will measure ADMA in serum and bronchoalveolar lavage samples to compare levels between HIV+ asthmatics and non-asthmatics and correlate ADMA with CT and biopsy measures of airway remodeling.</description>
  </secondary_outcome>
  <enrollment type="Actual">102</enrollment>
  <condition>Asthma</condition>
  <condition>HIV</condition>
  <condition>Adiposity</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>Blood will be drawn for plasma, serum, and peripheral blood mononuclear cells.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>The following questionnaires are administered to participants by study personnel: Gingo Asthma Questionnaire (GAQ) and the Asthma Quality of Life questionnaire (AQL).</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spirometry</intervention_name>
    <description>Spirometry is a simple breathing test that measures the amount of air in one's lungs and how well one can move that air by forcefully blowing 3 or more times into a mouthpiece. A series of these maneuvers will be performed under the instruction of a respiratory technician or respiratory therapist.</description>
    <other_name>Lung function testing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Methacholine challenge test</intervention_name>
    <description>A methacholine challenge is a common test often used to support a diagnosis of asthma. The test consists of inhaling increasing doses of methacholine through a nebulizer to assess how quickly the participant's airways narrow.</description>
    <other_name>Asthma Test</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Quantitative CT scans</intervention_name>
    <description>There will be a standard chest CT and an abdominal CT. The CT scans capture contiguous volume scans acquired at slice thicknesses of 5.0 mm in the axial plane and reconstructed with 512 x 512 pixel matrices. CT examinations will encompass the entire thorax and the abdomen and will be performed during a breath-hold at end-inspiration. The investigators will measure % of lung tissue below a threshold for emphysema (i.e. -950 Hounsfield units). Measurements have been histologically-verified and give reproducible measurements. The data set is assembled and analyzed with the image data anonymized. If the participant has had a research chest CT scan done recently, only the abdomen CT will be done.</description>
    <other_name>CT scan of the chest</other_name>
    <other_name>CT scan of the abdomen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Urine pregnancy test</intervention_name>
    <description>All female participants with childbearing potential will be asked to provide a urine sample for pregnancy testing. The result of the pregnancy test must be negative in order for her to be in this research study.</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adipose biopsy</intervention_name>
    <description>The doctor will obtain a sample of fat cells from the participant's abdomen. Numbing medicine will be applied. A needle is placed through the skin &amp; into the fat pad under the skin. A blunt-tip hollow cannula is then used to aspirate fat tissue through the incision.</description>
    <other_name>Fat pad biopsy</other_name>
    <other_name>Fat biopsy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Exhaled nitric oxide measurement</intervention_name>
    <description>The investigators will measure concentrations of exhaled nitric oxide by asking the participant to inhale deeply, and then exhale very slowly into a mouthpiece for between 10-15 seconds.</description>
    <other_name>ENO measurement</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, serum, bronchial wash and cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        HIV positive individuals in the Pittsburgh area&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. Subject who have been previously determined to be HIV positive through testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or breast-feeding&#xD;
&#xD;
          2. Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery&#xD;
             within 3 months, recent myocardial infarction, etc.)&#xD;
&#xD;
          3. Heart condition such as tachycardia, angina or arrhythmias&#xD;
&#xD;
          4. Acute respiratory infection: increasing respiratory symptoms or fever (temperature&#xD;
             &gt;100.4°F [38°C]) within 4 weeks of study entry&#xD;
&#xD;
          5. Hospitalization within 4 weeks of study entry&#xD;
&#xD;
          6. Uncontrolled hypertension at screening visit (systolic &gt; 160 mm Hg or diastolic &gt; 100&#xD;
             mm Hg) from an average of two or more readings (participant may return for screening&#xD;
             after blood pressure is controlled)&#xD;
&#xD;
          7. Active cancer requiring systemic chemotherapy or radiation&#xD;
&#xD;
          8. Active infection of lungs, brain, or abdomen; or intravenous drug use or alcohol use&#xD;
             that will impair ability to complete study investigations in the opinion of the&#xD;
             investigator&#xD;
&#xD;
          9. History of prior lung resection&#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>Alison Morris, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Alison Morris</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Asthma</keyword>
  <keyword>Adiposity</keyword>
  <keyword>Lung disease</keyword>
  <keyword>Weight</keyword>
  <keyword>Fat</keyword>
  <keyword>Obese</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitric Oxide</mesh_term>
    <mesh_term>Methacholine Chloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02975258
org study id: PRO15070529
secondary id: 1R56HL128134-01A1
nct id: NCT02975258
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The goals of this study are to 1) examine the relationships among inflammation, obesity, and
      asthma in people with HIV and 2) to test if special subtypes of cells or markers are present
      in the blood and lungs of people with HIV with asthma compared to those without asthma.
The proposed study involves the recruitment of participant population and the use of data
      from the existing research study cohorts that have been recruited and have provided informed
      consent for participation. Participants meet all inclusion/exclusion criteria will be
      enrolled into the study. Participants in the existing research study cohorts have pulmonary
      function testing, chest CT scans, and blood draws at each study visit which occurs every 18
      months for 3 visits. Some of the study procedures may not be repeated if they were done as
      part of other research projects.

        1. Main study visit

           The following research procedures may be performed over the course of one or more visits
           to accommodate scheduling needs. The study visit will take place at the Montefiore
           Clinical and Translational Research Center and the University of Pittsburgh Asthma
           Institute in the University of Pittsburgh Medical Center - Montefiore Hospital and may
           take up to 4 hours to complete.

             -  Informed consent

             -  Medical history review and demographics

             -  Review of inclusion/exclusion criteria

             -  Physical examination to include vital signs, weight and height, waist, hip, and
                thigh circumferences.

             -  Urine pregnancy test for female of childbearing potential

             -  Asthma-focused and quality of life questionnaire

             -  Exhaled Nitric Oxide (eNO) measurement

             -  Spirometry

             -  Methacholine challenge testing - will not need to be repeated if the participant
                had done this as part of another study in the past 6 months.

             -  Chest/Abdominal CT scans (If the participant has had the Chest CT scan done within
                6 months as part of other research study, they will not be repeated for study
                purposes. Only the Abdominal CT will be performed)

             -  Research blood sampling for biomarker analyses - some of this blood will also be
                used for pre-bronchoscopy testing in the case that the participant qualifies and is
                interested in undergoing part 2, the bronchoscopy visit.

             -  Adipose tissue biopsy (Fat Biopsy): performed on participants with a BMI≥25). This
                will be repeated if done previously because testing to be done on the fat will be
                different than what had been tested on the fat previously.

        2. Optional sub-study

      On a separate visit, only a subset of 60 selected participants will be asked to undergo the
      following procedures to obtain additional lung biological samples. This visit is optional for
      participants who are willing to participate in the bronchoscopy portion. The investigators
      will try to recruit an equal number (n=15 per group) of obese asthmatics, obese
      non-asthmatics, non-obese asthmatics, and non-obese non-asthmatics. The visit will take place
      in the Montefiore Clinical Translational Research Center (MUH-CTRC). The bronchoscopy
      procedure will take about 30-45 minutes, but the preparation and recovery time will usually
      make the visit about 4-8 hours total.

      Participants will be expected to fast for 8 hours prior to the bronchoscopy procedure and
      refrain from drinking any liquids the day of the procedure. Participants may take their usual
      medicines with sips of water.

      • Clinical laboratory testing to include complete blood count/differential/platelet count,
      prothrombin time/partial thromboplastin time, international Normalized Ratio, blood urea
      nitrogen, and creatinine prior to bronchoscopy. If the patient refuses the first blood draw,
      the sample is inadequate, or the labs were run more than 30 days prior to the bronchoscopy
      visit, a second blood sample of up to 1 tablespoon may be drawn prior to the bronchoscopy
      procedure to ensure the patient is healthy enough for the procedure.

      If Methacholine challenge was done more than 30 days prior to the visit two date, pulmonary
      function tests will be repeated.

        -  Oral Wash: participants will be asked to gargle with salt water for 1 minute and then
           spit into a container to provide a sample of approximately 10mls (2 teaspoons) at this
           study visit.

        -  Tongue Scraping: tongue blade or similar object will be used to scrape the participant's
           tongue. This sample will be used to determine what bacteria are on the participant's
           tongue. This procedure should only take minutes and is not painful.

        -  Participants will then rinse with 10cc's of Listerine. This is to assure that there are
           no bacteria left behind in the participant's mouth prior to the bronchoscopy.

        -  Bronchoscopy with bronchoalveolar lavage (BAL), endobronchial brushing and biopsy

      Under local anesthesia, participants will undergo bronchoscopy with BAL for microbiologic
      specimens. A light intravenous anesthetic will be titrated to provide participant comfort if
      necessary. Vitals signs will be monitored continuously before, during, and after the
      procedure. This procedure consists of 3 stages.

        1. Pulmonary Lavage: During pulmonary lavage, five 50 mL washes of sterile salt-water
           solution will be injected through the bronchoscope. Fluid will be collected with gentle
           suctioning for research studies.

        2. Bronchial Brushing: A small brush will be introduced through the bronchoscope and gently
           rubbed over a very small part of the surface of the lungs. Approximately 10 brushes will
           be performed to collect epithelial cells.

        3. Endobronchial Biopsy: While the bronchoscope is inserted, another small instrument will
           be passed through the bronchoscope to take small samples (biopsies) of tissue from the
           walls of the airways. Up to 5 samples may be taken during this procedure.

      Following the bronchoscopy procedure, participants will be closely monitored in the
      bronchoscopy recovery area or return to the CTRC. Rarely, the participant's asthma may worsen
      during or after the procedure. Appropriate medical treatments or overnight observation will
      be provided if needed. Participants will not be allowed to drive home after the bronchoscopy.
      This is because the sedatives used during the procedure may decrease driving ability. The
      investigators will ask for the contact name and number of the person that will pick up the
      participant after the bronchoscopy
observational model: Cohort
time perspective: Prospective
measure: Adverse interaction of adiposity and HIV-associated inflammation in asthma susceptibility and airway remodeling in HIV
time frame: Baseline
description: The investigator will test association of adiposity (body mass index, waist circumference, computed tomography (CT)-measured visceral adiposity) with prevalence of asthma and longitudinal progression of airway obstruction. the blood and lungs of people with HIV with asthma compared to those without asthma.
measure: Correlation between leptin and asthma susceptibility in HIV.
time frame: Baseline
description: Leptin, an obesity-related inflammatory marker, levels will be compared between HIV+ asthmatics and non-asthmatics and correlated with airway remodeling on endobronchial biopsy and CT.
measure: Correlation between adiponectin, asthma susceptibility, and airway remodeling in HIV.
time frame: Baseline
description: Adiponectin, an obesity-related inflammatory marker, levels will be compared between HIV+ asthmatics and non-asthmatics and correlated with airway remodeling on endobronchial biopsy and CT.
measure: Adipose tissue-related inflammation contributes to asthma susceptibility and airway remodeling in HIV.
time frame: Baseline
description: Using abdominal adipose tissue biopsies, the investigators will phenotype adipose-specific inflammatory cells and pathways and determine associations with asthma, airway remodeling, and longitudinal progression of airway obstruction.
measure: Low L-arginine increases asthma risk and airway remodeling in HIV.
time frame: Baseline
description: The investigator will measure L-arginine in serum and bronchoalveolar lavage samples to compare levels between HIV+ asthmatics and non-asthmatics and correlate L-arginine with CT and biopsy measures of airway remodeling.
measure: Low ADMA increases asthma risk and airway remodeling in HIV.
time frame: Baseline
description: The investigator will measure ADMA in serum and bronchoalveolar lavage samples to compare levels between HIV+ asthmatics and non-asthmatics and correlate ADMA with CT and biopsy measures of airway remodeling.
intervention type: Procedure
intervention name: Blood draw
description: Blood will be drawn for plasma, serum, and peripheral blood mononuclear cells.
intervention type: Other
intervention name: Questionnaires
description: The following questionnaires are administered to participants by study personnel: Gingo Asthma Questionnaire (GAQ) and the Asthma Quality of Life questionnaire (AQL).
intervention type: Procedure
intervention name: Spirometry
description: Spirometry is a simple breathing test that measures the amount of air in one's lungs and how well one can move that air by forcefully blowing 3 or more times into a mouthpiece. A series of these maneuvers will be performed under the instruction of a respiratory technician or respiratory therapist.
other name: Lung function testing
intervention type: Procedure
intervention name: Methacholine challenge test
description: A methacholine challenge is a common test often used to support a diagnosis of asthma. The test consists of inhaling increasing doses of methacholine through a nebulizer to assess how quickly the participant's airways narrow.
other name: Asthma Test
intervention type: Radiation
intervention name: Quantitative CT scans
description: There will be a standard chest CT and an abdominal CT. The CT scans capture contiguous volume scans acquired at slice thicknesses of 5.0 mm in the axial plane and reconstructed with 512 x 512 pixel matrices. CT examinations will encompass the entire thorax and the abdomen and will be performed during a breath-hold at end-inspiration. The investigators will measure % of lung tissue below a threshold for emphysema (i.e. -950 Hounsfield units). Measurements have been histologically-verified and give reproducible measurements. The data set is assembled and analyzed with the image data anonymized. If the participant has had a research chest CT scan done recently, only the abdomen CT will be done.
other name: CT scan of the chest
other name: CT scan of the abdomen
intervention type: Procedure
intervention name: Urine pregnancy test
description: All female participants with childbearing potential will be asked to provide a urine sample for pregnancy testing. The result of the pregnancy test must be negative in order for her to be in this research study.
intervention type: Procedure
intervention name: Adipose biopsy
description: The doctor will obtain a sample of fat cells from the participant's abdomen. Numbing medicine will be applied. A needle is placed through the skin & into the fat pad under the skin. A blunt-tip hollow cannula is then used to aspirate fat tissue through the incision.
other name: Fat pad biopsy
other name: Fat biopsy
intervention type: Procedure
intervention name: Exhaled nitric oxide measurement
description: The investigators will measure concentrations of exhaled nitric oxide by asking the participant to inhale deeply, and then exhale very slowly into a mouthpiece for between 10-15 seconds.
other name: ENO measurement
Whole blood, serum, bronchial wash and cells
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Alison Morris, MD, MS
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
citation: Gingo MR, Wenzel SE, Steele C, Kessinger CJ, Lucht L, Lawther T, Busch M, Hillenbrand ME, Weinman R, Slivka WA, McMahon DK, Zhang Y, Sciurba FC, Morris A. Asthma diagnosis and airway bronchodilator response in HIV-infected patients. J Allergy Clin Immunol. 2012 Mar;129(3):708-714.e8. doi: 10.1016/j.jaci.2011.11.015. Epub 2011 Dec 15.
PMID: 22177327
citation: Miranda C, Busacker A, Balzar S, Trudeau J, Wenzel SE. Distinguishing severe asthma phenotypes: role of age at onset and eosinophilic inflammation. J Allergy Clin Immunol. 2004 Jan;113(1):101-8. doi: 10.1016/j.jaci.2003.10.041.
PMID: 14713914
citation: Holguin F, Comhair SA, Hazen SL, Powers RW, Khatri SS, Bleecker ER, Busse WW, Calhoun WJ, Castro M, Fitzpatrick AM, Gaston B, Israel E, Jarjour NN, Moore WC, Peters SP, Teague WG, Chung KF, Erzurum SC, Wenzel SE. An association between L-arginine/asymmetric dimethyl arginine balance, obesity, and the age of asthma onset phenotype. Am J Respir Crit Care Med. 2013 Jan 15;187(2):153-9. doi: 10.1164/rccm.201207-1270OC. Epub 2012 Nov 29.
PMID: 23204252
citation: Gingo MR, George MP, Kessinger CJ, Lucht L, Rissler B, Weinman R, Slivka WA, McMahon DK, Wenzel SE, Sciurba FC, Morris A. Pulmonary function abnormalities in HIV-infected patients during the current antiretroviral therapy era. Am J Respir Crit Care Med. 2010 Sep 15;182(6):790-6. doi: 10.1164/rccm.200912-1858OC. Epub 2010 Jun 3.
PMID: 20522793
citation: Crothers K, Thompson BW, Burkhardt K, Morris A, Flores SC, Diaz PT, Chaisson RE, Kirk GD, Rom WN, Huang L; Lung HIV Study. HIV-associated lung infections and complications in the era of combination antiretroviral therapy. Proc Am Thorac Soc. 2011 Jun;8(3):275-81. doi: 10.1513/pats.201009-059WR.
PMID: 21653528
citation: Gingo MR, Balasubramani GK, Kingsley L, Rinaldo CR Jr, Alden CB, Detels R, Greenblatt RM, Hessol NA, Holman S, Huang L, Kleerup EC, Phair J, Sutton SH, Seaberg EC, Margolick JB, Wisniewski SR, Morris A. The impact of HAART on the respiratory complications of HIV infection: longitudinal trends in the MACS and WIHS cohorts. PLoS One. 2013;8(3):e58812. doi: 10.1371/journal.pone.0058812. Epub 2013 Mar 12.
PMID: 23554932
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responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Alison Morris
investigator title: Professor
mesh term: Obesity
mesh term: Inflammation
mesh term: Nitric Oxide
mesh term: Methacholine Chloride
sharing ipd: Undecided