Inflammation and Depression in People With HIV

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: HIV, Depression, Anhedonia

In brief

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.

Key facts

Study ID

NCT05849038

Run by

Emory University

People needed

60

Starts

2023-12-11

Expected to finish

2027-11-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≥10 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≥2mg/L
• Women of reproductive age will have a negative serum pregnancy test at study entry and both men and women must agree to adequate contraception while

You may not qualify if…

• < 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)
• Having taken the following immunosuppressive medications within the past 6 months:
• Oral corticosteroids
• Biologic treatments such as etanercept, infliximab, certolizumab, adalimumab, golimumab, tocilizumab, abatacept, Ustekinumab, ixekizumab, secukinumab, or anakinra
• Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-interferon (IFN) therapy)
• Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg)
• any Janus kinase (JAK) inhibitor
• 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)

Where it is running

• Grady Memorial Hospital — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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