Actively Recruiting
Phase II Study to Evaluate the Efficacy and Safety of Baricitinib for Reduction of HIV in the Central Nervous System
Led by William Tyor · Updated on 2026-03-23
95
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
W
William Tyor
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of baricitinib, an oral Janus Kinase inhibitor, on the persistence of HIV in the central nervous system (CNS). Despite effective antiretroviral therapy controlling HIV in the body, HIV reservoirs remain in the CNS, preventing a cure. The study focuses on whether baricitinib can reduce HIV levels in the brain and improve neurocognitive function, inflammation, and neuroimaging markers compared to placebo in people living with HIV who have durable viral suppression on ART. Participants will be randomly assigned to receive either baricitinib 2 mg orally once daily or a matching placebo for ten weeks. Both groups will have follow-up visits at weeks 1, 2, 4, and 10 to monitor treatment effects. Baricitinib has been shown in preclinical studies to cross the blood-brain barrier and reduce HIV in the CNS, making it a promising candidate for targeting HIV reservoirs in the brain. During the study, participants will undergo blood tests, neurocognitive assessments, MRI scans, and lumbar punctures at the start and end of the treatment period to measure HIV levels in the cerebrospinal fluid and blood. Researchers will evaluate changes in integrated HIV DNA, HIV RNA, inflammatory markers, and neuropsychological performance. Safety and tolerability will be closely monitored, and the total participation duration is approximately ten weeks.
CONDITIONS
Brief Title
Baricitinib for Reduction of HIV - CNS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV infected on continuous ART with plasma HIV RNA <200 copies/ml for at least 12 months
- Current CD4+ > 350 cells/microliter for at least twelve months
- Women of reproductive age must have a negative pregnancy test and agree to contraception
- Women at least 50 years old and amenorrheic for 12 months are exempt from contraception requirement
You will not qualify if you...
- Younger than 18 years or older than 65 years
- Pregnant or breastfeeding
- Significant blood abnormalities at screening (ANC < 1000, hemoglobin <10, platelets < 100,000)
- History of progressive multifocal leukoencephalopathy
- Untreated latent tuberculosis infection
- Use of immunosuppressive or anticoagulant medications within 1 month (aspirin allowed)
- History of deep venous thrombosis
- Cardiovascular disease including coronary artery disease, recent myocardial infarction, congestive heart failure with low ejection fraction, or history of stroke
- Hematologic cancers not in remission for over 5 years
- Major surgery within 8 weeks before screening or planned during the study
- Recent serious infections or untreated syphilis
- Symptomatic herpes simplex or herpes zoster infections recently
- Positive hepatitis B or chronic hepatitis C infection
- Liver cirrhosis
- Abnormal liver function tests above specified limits
- Chronic kidney disease with eGFR <40 mL/min/1.73 m2
- Dependence on illicit drugs except marijuana
- Bleeding disorders
- History of mass lesions or recent lumbar trauma
- Unable to consent, prisoners, cognitively impaired, non-English speakers, or community participation restrictions apply as detailed in criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants receive either baricitinib or placebo orally once daily for ten weeks to evaluate the effect on HIV in the central nervous system.
Follow-up visits at weeks 1, 2, 4, and 10
Trial Site Locations
Total: 2 locations
1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
H
Howard Pope
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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