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Inflammation and Depression in People With HIV

Primary Purpose

HIV, Depression, Anhedonia

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Baricitinib
Placebo
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Human Immunodeficiency Virus (HIV), Anhedonia, Psychomotor Slowing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV infected on continuous antiretroviral therapy (ART) with plasma HIV RNA <200 copies/ml for at least 12 months (on at least two previous clinic visits and confirmed at screening). Current cluster of differentiation 4 (CD4+) > 350 cells/microliter for at least twelve months (on at least two previous clinic visits and confirmed at screening). A primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) major depression, current, or Bipolar, depressed type as diagnosed by the SCID-V. Score of ≥15 on the 9-item Patient Health Questionnaire (PHQ-9). Off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks (8 weeks for fluoxetine) or on a stable psychotropic regimen for at least 4 weeks prior to baseline visit. Significant anhedonia as reflected by a score ≥ 2 on item #1 of the PHQ-9. CRP≥3mg/L. Women of reproductive age will have a negative serum pregnancy test at study entry and agree to contraception while on study drug. Exclusion Criteria: < 18 years of age or > 65 years of age Pregnancy or breastfeeding Significant hematological abnormalities at screening (ANC < 1500, Hgb<10, platelet< 100,000) History of progressive multifocal leukoencephalopathy Untreated latent tuberculosis infection (which will be screened for prior to entry) Immunosuppressive medications (including corticosteroids) and anticoagulants (aspirin acceptable) History of deep venous thrombosis Cardiovascular disease: Coronary artery disease or history of myocardial infarction Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines Stroke history Hematologic malignancies including lymphoma and leukemia Major surgery within 8 weeks prior to screening or will require major surgery during the study Current or recent (<4 weeks prior to randomization) clinically serious viral (including coronavirus disease 2019 [COVID-19]), bacterial, fungal, or parasitic infection or any other active or recent infection Symptomatic herpes simplex at the time of randomization Symptomatic herpes zoster infection within 12 weeks prior to randomization. History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement). Positive test for hepatitis B virus (HBV) defined as: positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) Hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive). Cirrhosis of the liver from any cause Any of the following specific abnormalities on screening laboratory tests: alanine transaminase (ALT) or aspartate aminotransferase (AST) >2 x upper limits of normal (ULN) alkaline phosphatase (ALP) ≥2 x ULN total bilirubin ≥1.5 x ULN (with the exception of patients on atazanavir, who must have total bilirubin <2 x ULN) Chronic kidney disease with estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m^2. History of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; substance abuse/dependence within 6 months of study entry (as determined by Severe combined immunodeficiency (SCID). A positive urine drug screen for illicit drugs at any time during the study excluding marijuana. An active suicidal plan as determined by a score >3 on item #3 on the Hamilton Rating Scale for Depression (HAM-D). An active eating disorder or antisocial personality disorder. <24 on the Mini-Mental State Exam. Chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications or minocycline within 2 weeks of baseline or at any time during the study. Any contraindication for MRI scanning. Failure of more than 2 antidepressant trials (at least 6 weeks at recommended dose) in the current episode or 5 antidepressant trials lifetime. BMI >40 (to exclude severe obesity). History of an autoimmune disorder

Sites / Locations

  • Grady Memorial Hospital
  • Emory University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Baricitinib

Placebo

Arm Description

Participants will be randomized to receive 10 weeks of treatment with baricitinib.

Participants will be randomized to receive 10 weeks of treatment with placebo.

Outcomes

Primary Outcome Measures

Change in corticostriatal functional connectivity (FC) in reward circuit
Patients will undergo resting-state and task-based functional magnetic resonance imaging (fMRI) to calculate functional connectivity (FC) between the ventral striatum (VS) and ventromedial prefrontal cortex (vmPFC). FC is measured as continuous Z scores reflecting the correlation of activity between the brain regions. Higher FC Z scores reflect stronger connectivity.

Secondary Outcome Measures

Change in Effort Expenditure for Reward Task (EEfRT) Score
The EEfRT is a widely used, multi-trial task measuring motivation for rewards as an assessment of anhedonia, as anhedonia is specifically associated with decreased motivation for rewards. For each task participants repeatedly press a button to raise a "bar" on a screen. Before each task participants choose between between receiving a "hard task" (using the non-dominant little finger) for a larger reward or an "easy task" (using the dominant index finger) for a smaller reward. The EEfRT is reported as the proportion of "hard task" trials that participants select. Possible scores range between 0 to 1 with higher scores indicating greater motivation, which in turn is an indication for lower anhedonia.
Change in Snaith-Hamilton Pleasure Scale-Self Report (SHAPS-SR) Score
The Snaith-Hamilton Pleasure Scale (SHAPS), a 14-item self-report scale with high psychometric validity for assessing the presence of anhedonia, is used to assess hedonic capacity. Participants rate how much they agree or disagree with 14 items phrased as "I would enjoy __" based on their ability to experience pleasure. Of the four possible response categories (Definitely Agree, Agree, Disagree, and Strongly Disagree), either of the Disagree responses receives a score of 1 and either of the Agree responses receives a score of 0. The total SHAPS score is calculated as the sum of these 14 items and ranges from 0 to 14, where higher SHAPS scores indicate greater anhedonia.
Change in Motivation and Pleasure Scale-Self-Report (MAP-SR) Score
The Motivation and Pleasure-Self-Report (MAP-SR) is an 18-item self-report inventory that was created to disentangle state-wise motivational and consummatory components of everyday activities over a 24-hour period. Participants respond to statements about daily activities on a 5-point Likert scale from 0 (no pleasure/not at all) to 4 (extreme pleasure/very often). Total scores range from 0 to 72 where higher scores indicate greater motivation and effort given to everyday situations.
Change in Inventory of Depressive Symptoms Self Report (IDS-SR) Anhedonia Subscale Score
Anhedonia is assessed with a 3-item subscale of the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Items are scored on a 4-point scale from 0 to 3. Total scores for the Anhedonia Subscale range from 0 to 9 with higher scores reflecting greater anhedonia.
Change in Multidimensional Fatigue Inventory (MFI) Score
The Multidimensional Fatigue Inventory (MFI) assesses 5 dimensions of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation. Participants read 20 statements (such as "I feel very active") and indicate how true that feeling is for them on a 5-point scale where "yes, that is true" = 1 and "no, that is not true" = 5. Total scores range from 20 to 100 and higher scores indicate greater fatigue.
Change in Finger Tapping Task (FTT) Mean Number of Taps
The Finger Tapping Task (FTT) uses a specially adapted tapper that the participant taps as fast as possible using the index finger. The participant is given 5 consecutive 10-second trials for the preferred and non-preferred hands. The FTT score is calculated as the mean number of taps for the preferred and non-preferred hands. The FTT is designed to assess subtle motor impairment and is altered in subjects with basal ganglia disorders and lesions. A lower score indicates motor impairment.
Change in Finger Tapping Task (FTT) Total Number of Taps
The Finger Tapping Task (FTT) uses a specially adapted tapper that the participant taps as fast as possible using the index finger. The participant is given 5 consecutive 10-second trials for the preferred and non-preferred hands. The FTT score is calculated as the total number of taps for the preferred and non-preferred hands. The FTT is designed to assess subtle motor impairment and is altered in subjects with basal ganglia disorders and lesions. A lower score indicates motor impairment.
Change in Trail Making Test Part A (TMT-A) Score
The Trail Making Test Part A (TMT-A) measures psychomotor processing speed by asking participants to accurately draw lines connecting circles printed on a piece of paper as quickly as possible. In Part A, participants connect 25 circles in numeric sequence and the test is scored as the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.
Change in Retardation Rating Scale (RRS) Score
The Retardation Rating Scale (RRS) is a 14-item, clinician-administered scale used to assess psychomotor retardation (a feature of depression) related to motility or mental activity. Items are scored on a scale from 0 to 4 where normal = 0 and extremely severe = 4. Total scores range from 0 to 56 where higher scores indicate increased severity of depression.

Full Information

First Posted
April 27, 2023
Last Updated
September 18, 2023
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05849038
Brief Title
Inflammation and Depression in People With HIV
Official Title
The Role of Inflammation in Central Nervous System (CNS) Mechanisms of Anhedonia and Psychomotor Slowing in Depressed People With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
November 2027 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this 10-week, double-blind, placebo-controlled study is to determine whether inflammation impacts reward and motor neural circuitry to contribute to depressive symptoms like anhedonia and psychomotor slowing in people with Human Immunodeficiency Virus (HIV) and depression. Sixty male and female patients with HIV who have depression, anhedonia and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks. Participants will complete lab tests, medical and psychiatric assessments, neurocognitive testing, functional MRI (fMRI) scans, and optional spinal taps as part of the study. The total length of participation is about 5 months.
Detailed Description
Risk of depression is substantially higher in people with HIV (PWH) than the general population, and depression in PWH confers worse outcomes regarding treatment adherence, morbidity and mortality. Increased inflammation is one biological pathway that is linked to greater risk for depression in PWH and limits options for effective antidepressant therapy. Chronically elevated inflammation is associated with impairments within reward and motor neural circuits that contribute to symptoms of anhedonia (an inability to experience pleasure) and psychomotor slowing, which are overrepresented in PWH. The purpose of this 10-week, double-blind, placebo-controlled study is to provide mechanistic information on whether inflammation impacts corticostriatal reward and motor circuitry to contribute to anhedonia and psychomotor slowing in PWH with depression using the anti-inflammatory drug baricitinib. This study will utilize an FDA-approved medication, baricitinib, to establish whether the effects of inflammation on reward and motor circuits are a mechanism of anhedonia and motor slowing in PWH with depression, while advancing avenues for new therapies. Sixty male and female patients with HIV who have depression and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either baricitinib or a placebo for 10 weeks. Participants will complete lab tests, medical and psychiatric assessments, neurocognitive testing, functional MRI (fMRI) scans, and optional spinal taps as part of the study. The total length of participation is about 3.5 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Depression, Anhedonia
Keywords
Human Immunodeficiency Virus (HIV), Anhedonia, Psychomotor Slowing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baricitinib
Arm Type
Experimental
Arm Description
Participants will be randomized to receive 10 weeks of treatment with baricitinib.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive 10 weeks of treatment with placebo.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
Olumiant
Intervention Description
Patients will receive baricitinib at a dose of 2 mg oral daily.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the baricitinib tablet.
Primary Outcome Measure Information:
Title
Change in corticostriatal functional connectivity (FC) in reward circuit
Description
Patients will undergo resting-state and task-based functional magnetic resonance imaging (fMRI) to calculate functional connectivity (FC) between the ventral striatum (VS) and ventromedial prefrontal cortex (vmPFC). FC is measured as continuous Z scores reflecting the correlation of activity between the brain regions. Higher FC Z scores reflect stronger connectivity.
Time Frame
Baseline visit, week 2, and week 10 after study medication
Secondary Outcome Measure Information:
Title
Change in Effort Expenditure for Reward Task (EEfRT) Score
Description
The EEfRT is a widely used, multi-trial task measuring motivation for rewards as an assessment of anhedonia, as anhedonia is specifically associated with decreased motivation for rewards. For each task participants repeatedly press a button to raise a "bar" on a screen. Before each task participants choose between between receiving a "hard task" (using the non-dominant little finger) for a larger reward or an "easy task" (using the dominant index finger) for a smaller reward. The EEfRT is reported as the proportion of "hard task" trials that participants select. Possible scores range between 0 to 1 with higher scores indicating greater motivation, which in turn is an indication for lower anhedonia.
Time Frame
Baseline visit, week 2 and week 10
Title
Change in Snaith-Hamilton Pleasure Scale-Self Report (SHAPS-SR) Score
Description
The Snaith-Hamilton Pleasure Scale (SHAPS), a 14-item self-report scale with high psychometric validity for assessing the presence of anhedonia, is used to assess hedonic capacity. Participants rate how much they agree or disagree with 14 items phrased as "I would enjoy __" based on their ability to experience pleasure. Of the four possible response categories (Definitely Agree, Agree, Disagree, and Strongly Disagree), either of the Disagree responses receives a score of 1 and either of the Agree responses receives a score of 0. The total SHAPS score is calculated as the sum of these 14 items and ranges from 0 to 14, where higher SHAPS scores indicate greater anhedonia.
Time Frame
Baseline visit, week 1, week 2, week 4, week 6, week 10
Title
Change in Motivation and Pleasure Scale-Self-Report (MAP-SR) Score
Description
The Motivation and Pleasure-Self-Report (MAP-SR) is an 18-item self-report inventory that was created to disentangle state-wise motivational and consummatory components of everyday activities over a 24-hour period. Participants respond to statements about daily activities on a 5-point Likert scale from 0 (no pleasure/not at all) to 4 (extreme pleasure/very often). Total scores range from 0 to 72 where higher scores indicate greater motivation and effort given to everyday situations.
Time Frame
Baseline visit, week 1, week 2, week 4, week 6, week 10
Title
Change in Inventory of Depressive Symptoms Self Report (IDS-SR) Anhedonia Subscale Score
Description
Anhedonia is assessed with a 3-item subscale of the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Items are scored on a 4-point scale from 0 to 3. Total scores for the Anhedonia Subscale range from 0 to 9 with higher scores reflecting greater anhedonia.
Time Frame
Baseline visit, week 1, week 2, week 4, week 6, and week 10
Title
Change in Multidimensional Fatigue Inventory (MFI) Score
Description
The Multidimensional Fatigue Inventory (MFI) assesses 5 dimensions of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation. Participants read 20 statements (such as "I feel very active") and indicate how true that feeling is for them on a 5-point scale where "yes, that is true" = 1 and "no, that is not true" = 5. Total scores range from 20 to 100 and higher scores indicate greater fatigue.
Time Frame
Baseline visit, week 1, week 2, week 4, week 6, and week 10
Title
Change in Finger Tapping Task (FTT) Mean Number of Taps
Description
The Finger Tapping Task (FTT) uses a specially adapted tapper that the participant taps as fast as possible using the index finger. The participant is given 5 consecutive 10-second trials for the preferred and non-preferred hands. The FTT score is calculated as the mean number of taps for the preferred and non-preferred hands. The FTT is designed to assess subtle motor impairment and is altered in subjects with basal ganglia disorders and lesions. A lower score indicates motor impairment.
Time Frame
Baseline visit, week 2 and week 10
Title
Change in Finger Tapping Task (FTT) Total Number of Taps
Description
The Finger Tapping Task (FTT) uses a specially adapted tapper that the participant taps as fast as possible using the index finger. The participant is given 5 consecutive 10-second trials for the preferred and non-preferred hands. The FTT score is calculated as the total number of taps for the preferred and non-preferred hands. The FTT is designed to assess subtle motor impairment and is altered in subjects with basal ganglia disorders and lesions. A lower score indicates motor impairment.
Time Frame
Baseline visit, week 2 and week 10
Title
Change in Trail Making Test Part A (TMT-A) Score
Description
The Trail Making Test Part A (TMT-A) measures psychomotor processing speed by asking participants to accurately draw lines connecting circles printed on a piece of paper as quickly as possible. In Part A, participants connect 25 circles in numeric sequence and the test is scored as the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.
Time Frame
Baseline visit, week 2 and week 10
Title
Change in Retardation Rating Scale (RRS) Score
Description
The Retardation Rating Scale (RRS) is a 14-item, clinician-administered scale used to assess psychomotor retardation (a feature of depression) related to motility or mental activity. Items are scored on a scale from 0 to 4 where normal = 0 and extremely severe = 4. Total scores range from 0 to 56 where higher scores indicate increased severity of depression.
Time Frame
Baseline visit, week 1, week 2, week 4, week 6, and week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV infected on continuous antiretroviral therapy (ART) with plasma HIV RNA <200 copies/ml for at least 12 months (on at least two previous clinic visits and confirmed at screening). Current cluster of differentiation 4 (CD4+) > 350 cells/microliter for at least twelve months (on at least two previous clinic visits and confirmed at screening). A primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) major depression, current, or Bipolar, depressed type as diagnosed by the SCID-V. Score of ≥15 on the 9-item Patient Health Questionnaire (PHQ-9). Off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks (8 weeks for fluoxetine) or on a stable psychotropic regimen for at least 4 weeks prior to baseline visit. Significant anhedonia as reflected by a score ≥ 2 on item #1 of the PHQ-9. CRP≥3mg/L. Women of reproductive age will have a negative serum pregnancy test at study entry and agree to contraception while on study drug. Exclusion Criteria: < 18 years of age or > 65 years of age Pregnancy or breastfeeding Significant hematological abnormalities at screening (ANC < 1500, Hgb<10, platelet< 100,000) History of progressive multifocal leukoencephalopathy Untreated latent tuberculosis infection (which will be screened for prior to entry) Immunosuppressive medications (including corticosteroids) and anticoagulants (aspirin acceptable) History of deep venous thrombosis Cardiovascular disease: Coronary artery disease or history of myocardial infarction Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines Stroke history Hematologic malignancies including lymphoma and leukemia Major surgery within 8 weeks prior to screening or will require major surgery during the study Current or recent (<4 weeks prior to randomization) clinically serious viral (including coronavirus disease 2019 [COVID-19]), bacterial, fungal, or parasitic infection or any other active or recent infection Symptomatic herpes simplex at the time of randomization Symptomatic herpes zoster infection within 12 weeks prior to randomization. History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement). Positive test for hepatitis B virus (HBV) defined as: positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) Hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive). Cirrhosis of the liver from any cause Any of the following specific abnormalities on screening laboratory tests: alanine transaminase (ALT) or aspartate aminotransferase (AST) >2 x upper limits of normal (ULN) alkaline phosphatase (ALP) ≥2 x ULN total bilirubin ≥1.5 x ULN (with the exception of patients on atazanavir, who must have total bilirubin <2 x ULN) Chronic kidney disease with estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m^2. History of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; substance abuse/dependence within 6 months of study entry (as determined by Severe combined immunodeficiency (SCID). A positive urine drug screen for illicit drugs at any time during the study excluding marijuana. An active suicidal plan as determined by a score >3 on item #3 on the Hamilton Rating Scale for Depression (HAM-D). An active eating disorder or antisocial personality disorder. <24 on the Mini-Mental State Exam. Chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications or minocycline within 2 weeks of baseline or at any time during the study. Any contraindication for MRI scanning. Failure of more than 2 antidepressant trials (at least 6 weeks at recommended dose) in the current episode or 5 antidepressant trials lifetime. BMI >40 (to exclude severe obesity). History of an autoimmune disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Felger, PhD
Phone
404-727-3987
Email
jfelger@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew H Miller, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Felger, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert M Anderson, MD
Phone
404-616-3147
Email
aande2@emory.edu
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew H Miller, MD
Phone
404-727-8260
Email
amill02@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be made available for sharing through the National Institute of Mental Health Data Archive (NDA) data sharing platform hosted by the National Institute of Mental Health (NIMH).
IPD Sharing Time Frame
Data will be available for sharing after publication of the results from this study.
IPD Sharing Access Criteria
De-identified human subjects data, harmonized to a common standard, are available to qualified researchers. Summary data are available to all.
IPD Sharing URL
http://nda.nih.gov/

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Inflammation and Depression in People With HIV

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