<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/NCT03308331</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00075780</org_study_id>
    <nct_id>NCT03308331</nct_id>
  </id_info>
  <brief_title>HIV-1 and Brain Interaction on Smoking Comorbidity</brief_title>
  <official_title>HIV-1 and Brain Interaction on Smoking Comorbidity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</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>
      People living with HIV-1 have high rates of cigarette smoking, which may be related to&#xD;
      nicotinic interaction with HIV-1 infection and brain function levels. The proposed project&#xD;
      aims to understand these pathways using translational brain imaging and HIV-1 reactivation&#xD;
      studies. The study proposes a targeted nicotine-brain investigation of the nicotinic effects&#xD;
      in HIV-1 infection from cellular to brain circuitry levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking remains the leading cause of preventable morbidity and mortality in the United&#xD;
      States. The alarmingly high smoking rates and unsatisfactory performance of standard smoking&#xD;
      cessation efforts in people living with HIV/AIDS (PLWH) interfere with the overall progress&#xD;
      in the treatment of HIV-1 infection. Our understanding of nicotine addiction mechanisms in&#xD;
      PLWH, and how they are related to and interact with HIV-1 neuropathology, is limited and thus&#xD;
      hindering the development of more effective, targeted treatments. The study will directly&#xD;
      address neurological complication of this HIV-associated comorbidity at the brain circuitry&#xD;
      level using state-of-the-art imaging tools and methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We originally had a collaboration with a PI but he has left the University.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2019</start_date>
  <completion_date type="Anticipated">October 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2025</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional and structural connectivity using magnetic resonance imaging (MRI)</measure>
    <time_frame>one day</time_frame>
    <description>Resting functional MRI and diffusion imaging MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV-1 reactivation</measure>
    <time_frame>one day</time_frame>
    <description>HIV-1 viral protein p24 expression</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>HIV-1 smokers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV-1 nonsmokers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control smokers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control nonsmokers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV-1 nonsmokers using nicotine patch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV-1 nonsmokers using placebo patch</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control nonsmokers using nicotine patch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control nonsmokers using placebo patch</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tobacco smoking and nicotine patch</intervention_name>
    <description>Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use</description>
    <arm_group_label>HIV-1 nonsmokers using nicotine patch</arm_group_label>
    <arm_group_label>HIV-1 smokers</arm_group_label>
    <arm_group_label>Healthy control nonsmokers using nicotine patch</arm_group_label>
    <arm_group_label>Healthy control smokers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects between ages 18-60 in good health&#xD;
&#xD;
          2. Ability to give written informed consent&#xD;
&#xD;
          3. For people living with HIV: should be diagnosed with HIV two years or more and on ART&#xD;
             two years or more&#xD;
&#xD;
          4. For people living with HIV: should have achieved virologic suppression (defined as&#xD;
             viral loads of ≤ 200 copies/ml), and without current signs of reactivation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to sign informed consent&#xD;
&#xD;
          2. Unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker&#xD;
             or neurostimulator, some artificial joints, metal pins, surgical clips or other&#xD;
             implanted metal parts) or claustrophobic to the scanner&#xD;
&#xD;
          3. Any major medical illnesses to include, but not limited to, uncontrolled high blood&#xD;
             pressure or high blood sugar, cardiovascular disease, asthma, peripheral vascular&#xD;
             diseases, coagulopathies, history of superficial or deep vein thrombosis as per&#xD;
             medical history&#xD;
&#xD;
          4. Current substance-induced psychiatric disorders&#xD;
&#xD;
          5. Significant alcohol or other drug use, other than nicotine dependence or marijuana use&#xD;
&#xD;
          6. Gross structural abnormalities and/or have a history of syncope&#xD;
&#xD;
          7. Positive urine pregnancy tests&#xD;
&#xD;
          8. Any neurological illnesses to include, but not limited to, seizure disorders, multiple&#xD;
             sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor,&#xD;
&#xD;
          9. For people living with HIV: having AIDS or non-AIDS-defining cancer or active CNS and&#xD;
             other opportunistic disease&#xD;
&#xD;
         10. For people living with HIV: on active treatment of hepatitis C virus (HCV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Maryland School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>L. Elliot Hong</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>nicotine</keyword>
  <keyword>brain</keyword>
  <keyword>smoking</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_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/NCT03308331
org study id: HP-00075780
nct id: NCT03308331
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People living with HIV-1 have high rates of cigarette smoking, which may be related to
      nicotinic interaction with HIV-1 infection and brain function levels. The proposed project
      aims to understand these pathways using translational brain imaging and HIV-1 reactivation
      studies. The study proposes a targeted nicotine-brain investigation of the nicotinic effects
      in HIV-1 infection from cellular to brain circuitry levels.
Smoking remains the leading cause of preventable morbidity and mortality in the United
      States. The alarmingly high smoking rates and unsatisfactory performance of standard smoking
      cessation efforts in people living with HIV/AIDS (PLWH) interfere with the overall progress
      in the treatment of HIV-1 infection. Our understanding of nicotine addiction mechanisms in
      PLWH, and how they are related to and interact with HIV-1 neuropathology, is limited and thus
      hindering the development of more effective, targeted treatments. The study will directly
      address neurological complication of this HIV-associated comorbidity at the brain circuitry
      level using state-of-the-art imaging tools and methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Functional and structural connectivity using magnetic resonance imaging (MRI)
time frame: one day
description: Resting functional MRI and diffusion imaging MRI
measure: HIV-1 reactivation
time frame: one day
description: HIV-1 viral protein p24 expression
arm group label: HIV-1 smokers
arm group type: Experimental
arm group label: HIV-1 nonsmokers
arm group type: No Intervention
arm group label: Healthy control smokers
arm group type: Active Comparator
arm group label: Healthy control nonsmokers
arm group type: No Intervention
arm group label: HIV-1 nonsmokers using nicotine patch
arm group type: Active Comparator
arm group label: HIV-1 nonsmokers using placebo patch
arm group type: No Intervention
arm group label: Healthy control nonsmokers using nicotine patch
arm group type: Active Comparator
arm group label: Healthy control nonsmokers using placebo patch
arm group type: No Intervention
intervention type: Other
intervention name: Tobacco smoking and nicotine patch
description: Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use
arm group label: HIV-1 nonsmokers using nicotine patch
arm group label: HIV-1 smokers
arm group label: Healthy control nonsmokers using nicotine patch
arm group label: Healthy control smokers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: L. Elliot Hong
investigator title: MD
mesh term: Nicotine