<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/NCT03237689</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00145327</org_study_id>
    <secondary_id>R01MH113512</secondary_id>
    <nct_id>NCT03237689</nct_id>
  </id_info>
  <brief_title>Effects of Glucocorticoids on Cognition in HIV-infected Women</brief_title>
  <acronym>MsSCORE</acronym>
  <official_title>Effects of Glucocorticoids on Cognition in HIV-infected Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite treatment with antiretroviral therapy, women living with HIV continue to experience&#xD;
      cognitive impairment. Psychological risk factors, including stress, impair cognition more in&#xD;
      HIV-infected women than HIV-uninfected women. This study plans to examine a novel&#xD;
      intervention for cognitive dysfunction that targets the mechanisms by which stress negatively&#xD;
      affects cognitive functioning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall aim of this study is to contribute important foundational knowledge of the&#xD;
      utility of targeting neuroinflammation and the hypothalamic-pituitary-adrenal (HPA) axis to&#xD;
      improve cognition in HIV and will provide key clinical insights into the mechanisms&#xD;
      underlying any cognitive benefit. The investigators are conducting a single-dose study of low&#xD;
      dose hydrocortisone (LDH) followed by a 4-week study of daily LDH as a probe of the&#xD;
      mechanisms of neuroinflammation including myeloid-lineage cells and the HPA axis in&#xD;
      HIV-infected (HIV+) women demonstrating cognitive dysfunction and reporting high levels of&#xD;
      stress, trauma history, and mental health risk factors which commonly occur in this&#xD;
      population. The use of a pharmacological challenge may aid in the identification of: 1) a&#xD;
      putative biomarker of stress- and psychiatric disorder-related neurocognitive complications&#xD;
      in HIV-infected women and/or 2) an adjunctive, cost-effective therapy for the treatment of&#xD;
      cognitive deficits in HIV&#xD;
&#xD;
      The design is a two-phase study of HIV+ women who: 1) first participate in a double-blind,&#xD;
      placebo-controlled cross-over study of a single, low dose (10 mg) of hydrocortisone versus&#xD;
      placebo on cognition; and 2) then participate in a mechanistic, randomized, double-blind,&#xD;
      placebo controlled trial of daily LDH for 4 weeks on cognition and side effects. The clinical&#xD;
      trial will include 100 virally suppressed HIV+ women who show elevated stress and cognitive&#xD;
      impairment and who represent the range of psychological risk factors characteristic of this&#xD;
      population. Next, to understand the mechanism and broader clinical significance of LDH on&#xD;
      cognition, investigators will conduct a 4-week randomized study of the effects of daily&#xD;
      treatment with LDH versus placebo on cognition in HIV+ women (targeted n=80).&#xD;
&#xD;
      Women meeting enrollment criteria will complete three cognitive assessments. The first and&#xD;
      second assessments will be embedded in the double-blind, placebo-controlled, cross-over study&#xD;
      of a single administration of LDH versus placebo (targeted n=100). Investigators will measure&#xD;
      cognitive performance 30 minutes and 4 hours post-dosing, because an emerging literature&#xD;
      shows that the cognitive effects of LDH depends on timing of the assessment post-dosing. The&#xD;
      30-minute assessment addresses how the maximal cortisol levels following LDH affect&#xD;
      cognition. This immediate assessment is standard in studies of stress and cognition and&#xD;
      allows for comparisons with the broader literature. More novel and clinically important is&#xD;
      the 4-hour assessment which occurs post-peak, when cortisol levels are more steady state and&#xD;
      typical of the broader daily cortisol profile following LDH. The third assessment will take&#xD;
      place after 4 weeks of treatment with LDH or placebo. That assessment addresses the clinical&#xD;
      significance and safety of longer-term LDH treatment. Lastly, the investigators will explore&#xD;
      glucocorticoids and inflammation and immune activation as mechanisms by which LDH might&#xD;
      affect cognition.&#xD;
&#xD;
      Objective 1 To examine immediate and delayed effects of a single administration of LDH on&#xD;
      cognition in HIV+ women.&#xD;
&#xD;
      Objective 2 To examine the effects of a 4-week course of daily LDH on cognition in HIV+&#xD;
      women.&#xD;
&#xD;
      Objective 3 To investigate potential mechanisms of LDH effects on cognition in HIV+ women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2023</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>The design is a two-phase study of HIV+ women who: 1) first participate in a double-blind, placebo-controlled cross-over study of a single, low dose (10 mg) of hydrocortisone versus placebo on cognition; and 2) then participate in a mechanistic, randomized, double-blind, placebo controlled trial of daily LDH for 4 weeks on cognition and side effects.&#xD;
Below includes the number of arms for the second study phase and is the phase of the study being considered a Phase 0 clinical trial. All information to follow will pertain to this phase of the study.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The only entity knowledgeable of randomization is the Johns Hopkins University Investigational Drug Service Pharmacy. They are responsible for randomizing and encapsulating the drug and placebo tablets</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hopkins Verbal Learning Test-Revised assesses total learning</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>a 12-item list-learning task across 3 trials used to measure total learning. Outcome=total learning across trials (range 0-36). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hopkins Verbal Learning Test-Revised assesses verbal memory</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>following the 3 learning trials there is a 20-25 minute delay. After the delay, participants are asked to recall as many words as they can from the initial learning list. Outcome=delayed free recall (range 0-12).Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Adult Intelligence Scale IV Letter-Number Sequencing assesses working memory condition</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>participants hear a series of letters and numbers, and then recite them back in ascending order, with the numbers first and then the letters. Outcome=total correct (range 0-24). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Line Orientation Task assesses visuospatial abilities</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>In each of 10 trials, a visual array of 13 lines fans out from a common point of origin. Two target lines are shown beneath each array, and participants must identify the lines within the array that match each of the two target lines. Outcome=Total correct (range=0-20).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test Part A assesses processing speed/attention</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>25 circles distributed over a sheet of paper. The circles are numbered 1 - 25 and the participant should draw lines to connect the numbers in ascending order. Outcome=Time to completion (range: 10 to 300 seconds). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test Part B assesses mental flexibility</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>25 circles are distributed over a sheet of paper. Circles include both numbers (1 - 13) and letters (A - L). The participant draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Outcome=time to completion (range: 18-300). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comalli Stroop Test, Trial 1 assesses processing speed/attention</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>Participants identify aloud the colors of a series of squares. Outcome=time to completion (range: 30 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comalli Stroop Test, Trial 2 assesses processing speed/attention</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>Participants read a series of color names printed in black ink. Outcome=time to completion (range: 30 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comalli Stroop Test, Trial 3 assesses behavioral inhibition</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>Participants name the color of the ink but ignore the word. Outcome=time to completion (range: 50 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function as assessed by aspartate aminotransferase (AST) levels</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function as assessed by alanine transaminase (ALT) levels</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function as assessed by alkaline phosphatase levels</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>renal function assessed by creatinine levels</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolic function assessed by glucose levels</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolic function assessed by hemoglobin A1c (HbA1c)</measure>
    <time_frame>change between baseline and 28 days</time_frame>
    <description>levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">148</enrollment>
  <condition>Hiv</condition>
  <arm_group>
    <arm_group_label>Hydrocortisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose hydrocortisone (10mg orally)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets, made of starch 1500 powder</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortisone</intervention_name>
    <description>Low dose hydrocortisone (10mg)</description>
    <arm_group_label>Hydrocortisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>capsules of starch 1500 powder</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females only;&#xD;
&#xD;
          -  HIV-infected;&#xD;
&#xD;
          -  Able to give informed consent;&#xD;
&#xD;
          -  Able to travel to study site for study participation;&#xD;
&#xD;
          -  Age between 18 and 65;&#xD;
&#xD;
          -  English as a first language;&#xD;
&#xD;
          -  Above-average self-reported levels of perceived stress (&gt;14 on the perceived stress&#xD;
             scale (PSS-10)) and/or current SCID-V diagnosis of mood and/or anxiety disorder;&#xD;
&#xD;
          -  Meet criteria for HIV-associated cognitive dysfunction (based on Neurocognitive test&#xD;
             battery and instrumental activities of daily living assessment-impairment on only 1&#xD;
             cognitive domain is required)&#xD;
&#xD;
          -  Virally suppressed and on combination antiretroviral therapy (Plasma HIV RNA&lt;1000cp/ml&#xD;
             and bring in medications)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of hormone-based contraceptives (birth control pills or patch);&#xD;
&#xD;
          -  Currently pregnant, post-partum or lactating;&#xD;
&#xD;
          -  Currently regular use of steroids;&#xD;
&#xD;
          -  History of closed head injury resulting in loss of consciousness greater than 1 hour;&#xD;
&#xD;
          -  History of schizophrenia or schizoaffective disorder;&#xD;
&#xD;
          -  Current untreated hypertension or diabetes*;&#xD;
&#xD;
          -  History of dementia or any other neurologic central nervous system (CNS) or&#xD;
             AIDS-defining disorder;&#xD;
&#xD;
          -  Positive urine toxicology screen (except marijuana) or breathalyzer and/or any&#xD;
             evidence of acute intoxication or withdrawal.&#xD;
&#xD;
          -  History of substance abuse/dependence in the past six months.&#xD;
&#xD;
        Participants who present with a heretofore untreated condition (e.g., hypertension) will be&#xD;
        excluded; however, they may be rescreened for eligibility after receiving appropriate&#xD;
        treatment for the condition in the course of their standard medical care (at least 6&#xD;
        months).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leah Rubin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leah H Rubin, PhD, MPH</last_name>
    <phone>410-955-7311</phone>
    <email>lrubin1@jhmi.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leah Rubin</last_name>
      <email>lrubin1@jhu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/28141781</url>
    <description>Brief Report: Low-Dose Hydrocortisone Has Acute Enhancing Effects on Verbal Learning in HIV-Infected Men</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/27094924</url>
    <description>Elevated stress is associated with prefrontal cortex dysfunction during a verbal memory task in women with HIV</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/26408051</url>
    <description>Prefrontal cortical volume loss is associated with stress-related deficits in verbal learning and memory in HIV-infected women</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/26404435</url>
    <description>Post-traumatic stress is associated with verbal learning, memory, and psychomotor speed in HIV-infected and HIV-uninfected women</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/25791344</url>
    <description>The association of perceived stress and verbal memory is greater in HIV-infected versus HIV-uninfected women</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</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/NCT03237689
org study id: IRB00145327
secondary id: R01MH113512
nct id: NCT03237689
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Despite treatment with antiretroviral therapy, women living with HIV continue to experience
      cognitive impairment. Psychological risk factors, including stress, impair cognition more in
      HIV-infected women than HIV-uninfected women. This study plans to examine a novel
      intervention for cognitive dysfunction that targets the mechanisms by which stress negatively
      affects cognitive functioning.
The overall aim of this study is to contribute important foundational knowledge of the
      utility of targeting neuroinflammation and the hypothalamic-pituitary-adrenal (HPA) axis to
      improve cognition in HIV and will provide key clinical insights into the mechanisms
      underlying any cognitive benefit. The investigators are conducting a single-dose study of low
      dose hydrocortisone (LDH) followed by a 4-week study of daily LDH as a probe of the
      mechanisms of neuroinflammation including myeloid-lineage cells and the HPA axis in
      HIV-infected (HIV+) women demonstrating cognitive dysfunction and reporting high levels of
      stress, trauma history, and mental health risk factors which commonly occur in this
      population. The use of a pharmacological challenge may aid in the identification of: 1) a
      putative biomarker of stress- and psychiatric disorder-related neurocognitive complications
      in HIV-infected women and/or 2) an adjunctive, cost-effective therapy for the treatment of
      cognitive deficits in HIV

      The design is a two-phase study of HIV+ women who: 1) first participate in a double-blind,
      placebo-controlled cross-over study of a single, low dose (10 mg) of hydrocortisone versus
      placebo on cognition; and 2) then participate in a mechanistic, randomized, double-blind,
      placebo controlled trial of daily LDH for 4 weeks on cognition and side effects. The clinical
      trial will include 100 virally suppressed HIV+ women who show elevated stress and cognitive
      impairment and who represent the range of psychological risk factors characteristic of this
      population. Next, to understand the mechanism and broader clinical significance of LDH on
      cognition, investigators will conduct a 4-week randomized study of the effects of daily
      treatment with LDH versus placebo on cognition in HIV+ women (targeted n=80).

      Women meeting enrollment criteria will complete three cognitive assessments. The first and
      second assessments will be embedded in the double-blind, placebo-controlled, cross-over study
      of a single administration of LDH versus placebo (targeted n=100). Investigators will measure
      cognitive performance 30 minutes and 4 hours post-dosing, because an emerging literature
      shows that the cognitive effects of LDH depends on timing of the assessment post-dosing. The
      30-minute assessment addresses how the maximal cortisol levels following LDH affect
      cognition. This immediate assessment is standard in studies of stress and cognition and
      allows for comparisons with the broader literature. More novel and clinically important is
      the 4-hour assessment which occurs post-peak, when cortisol levels are more steady state and
      typical of the broader daily cortisol profile following LDH. The third assessment will take
      place after 4 weeks of treatment with LDH or placebo. That assessment addresses the clinical
      significance and safety of longer-term LDH treatment. Lastly, the investigators will explore
      glucocorticoids and inflammation and immune activation as mechanisms by which LDH might
      affect cognition.

      Objective 1 To examine immediate and delayed effects of a single administration of LDH on
      cognition in HIV+ women.

      Objective 2 To examine the effects of a 4-week course of daily LDH on cognition in HIV+
      women.

      Objective 3 To investigate potential mechanisms of LDH effects on cognition in HIV+ women.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The design is a two-phase study of HIV+ women who: 1) first participate in a double-blind, placebo-controlled cross-over study of a single, low dose (10 mg) of hydrocortisone versus placebo on cognition; and 2) then participate in a mechanistic, randomized, double-blind, placebo controlled trial of daily LDH for 4 weeks on cognition and side effects.
Below includes the number of arms for the second study phase and is the phase of the study being considered a Phase 0 clinical trial. All information to follow will pertain to this phase of the study.
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The only entity knowledgeable of randomization is the Johns Hopkins University Investigational Drug Service Pharmacy. They are responsible for randomizing and encapsulating the drug and placebo tablets
measure: Hopkins Verbal Learning Test-Revised assesses total learning
time frame: change between baseline and 28 days
description: a 12-item list-learning task across 3 trials used to measure total learning. Outcome=total learning across trials (range 0-36). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
measure: Hopkins Verbal Learning Test-Revised assesses verbal memory
time frame: change between baseline and 28 days
description: following the 3 learning trials there is a 20-25 minute delay. After the delay, participants are asked to recall as many words as they can from the initial learning list. Outcome=delayed free recall (range 0-12).Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
measure: Wechsler Adult Intelligence Scale IV Letter-Number Sequencing assesses working memory condition
time frame: change between baseline and 28 days
description: participants hear a series of letters and numbers, and then recite them back in ascending order, with the numbers first and then the letters. Outcome=total correct (range 0-24). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Line Orientation Task assesses visuospatial abilities
time frame: change between baseline and 28 days
description: In each of 10 trials, a visual array of 13 lines fans out from a common point of origin. Two target lines are shown beneath each array, and participants must identify the lines within the array that match each of the two target lines. Outcome=Total correct (range=0-20).
measure: Trail Making Test Part A assesses processing speed/attention
time frame: change between baseline and 28 days
description: 25 circles distributed over a sheet of paper. The circles are numbered 1 - 25 and the participant should draw lines to connect the numbers in ascending order. Outcome=Time to completion (range: 10 to 300 seconds). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
measure: Trail Making Test Part B assesses mental flexibility
time frame: change between baseline and 28 days
description: 25 circles are distributed over a sheet of paper. Circles include both numbers (1 - 13) and letters (A - L). The participant draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Outcome=time to completion (range: 18-300). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
measure: Comalli Stroop Test, Trial 1 assesses processing speed/attention
time frame: change between baseline and 28 days
description: Participants identify aloud the colors of a series of squares. Outcome=time to completion (range: 30 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
measure: Comalli Stroop Test, Trial 2 assesses processing speed/attention
time frame: change between baseline and 28 days
description: Participants read a series of color names printed in black ink. Outcome=time to completion (range: 30 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
measure: Comalli Stroop Test, Trial 3 assesses behavioral inhibition
time frame: change between baseline and 28 days
description: Participants name the color of the ink but ignore the word. Outcome=time to completion (range: 50 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
measure: Liver function as assessed by aspartate aminotransferase (AST) levels
time frame: change between baseline and 28 days
description: levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
measure: Liver function as assessed by alanine transaminase (ALT) levels
time frame: change between baseline and 28 days
description: levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
measure: Liver function as assessed by alkaline phosphatase levels
time frame: change between baseline and 28 days
description: levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
measure: renal function assessed by creatinine levels
time frame: change between baseline and 28 days
description: levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
measure: metabolic function assessed by glucose levels
time frame: change between baseline and 28 days
description: levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
measure: metabolic function assessed by hemoglobin A1c (HbA1c)
time frame: change between baseline and 28 days
description: levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
arm group label: Hydrocortisone
arm group type: Experimental
description: Low dose hydrocortisone (10mg orally)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablets, made of starch 1500 powder
intervention type: Drug
intervention name: Hydrocortisone
description: Low dose hydrocortisone (10mg)
arm group label: Hydrocortisone
intervention type: Drug
intervention name: Placebo Oral Tablet
description: capsules of starch 1500 powder
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Leah Rubin
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Leah H Rubin, PhD, MPH
phone: 410-955-7311
email: lrubin1@jhmi.edu
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.ncbi.nlm.nih.gov/pubmed/28141781
description: Brief Report: Low-Dose Hydrocortisone Has Acute Enhancing Effects on Verbal Learning in HIV-Infected Men
url: https://www.ncbi.nlm.nih.gov/pubmed/27094924
description: Elevated stress is associated with prefrontal cortex dysfunction during a verbal memory task in women with HIV
url: https://www.ncbi.nlm.nih.gov/pubmed/26408051
description: Prefrontal cortical volume loss is associated with stress-related deficits in verbal learning and memory in HIV-infected women
url: https://www.ncbi.nlm.nih.gov/pubmed/26404435
description: Post-traumatic stress is associated with verbal learning, memory, and psychomotor speed in HIV-infected and HIV-uninfected women
url: https://www.ncbi.nlm.nih.gov/pubmed/25791344
description: The association of perceived stress and verbal memory is greater in HIV-infected versus HIV-uninfected women
responsible party type: Sponsor
mesh term: Hydrocortisone
sharing ipd: Undecided