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New treatment option for HIV
Official title Inflammation and Depression in People With HIV
ClinicalTrials.gov ID: NCT05849038
What this study is testing
What is Baricitinib?
Baricitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hiv.
Also referred to as Olumiant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- Current cluster of differentiation 4 (CD4+) \> 350 cells/microliter for at least twelve months (on at least two previous clinic visits and confirmed...
- A primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) major depression, current, or Bipolar, depressed...
- 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...
You likely can't join if
- \ 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:
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- \ 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)
- 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
- History of dementia
- Chronic use of 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 \>42 (to exclude severe obesity) or at the investigator's discretion based on the patient's ability to fit in the MRI scanner
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.