Baricitinib for HIV in the Brain and Spinal Cord

This study is testing if Baricitinib, a drug already approved for other conditions, can help reduce HIV in the central nervous system (CNS), which includes your brain and spinal cord. Even with current treatments, HIV can hide in the CNS, making it hard to get rid of completely. You could be eligible if you are 18-65 years old, have HIV, and have been on continuous antiretroviral therapy (ART) with a very low viral load for at least 12 months. Participants will receive either Baricitinib or a placebo (an inactive substance) for ten weeks. The main goal is to see if Baricitinib changes the amount of HIV DNA in your spinal fluid after ten weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 95 participants. It compares Baricitinib to a placebo, meaning some participants will receive the active drug and others will receive an inactive substance.
What's involved
You would take a 2 mg oral tablet daily for ten weeks. You would have follow-up visits at weeks 1, 2, 4, and 10.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at week 10, indicating follow-up during and immediately after the treatment period.

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NCT05452564

Baricitinib for Reduction of HIV - CNS

Recruiting
PHASE2Ages 18–65InterventionalTreatment
William Tyor
~95 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:Baricitinib 2 MG Oral TabletPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in CSF integrated proviral DNA
Measured over Baseline and study week 10
Human Immunodeficiency Virus
2 sites across 1 states
Georgia2
  • William Tyor, MD · PRINCIPAL_INVESTIGATOR · Professor

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
Cognitively impaired or Individuals with Impaired Decision-Making Capacity
Individuals who are not able to clearly understand English
Community Participation (if applicable)
  • Changes in CSF integrated proviral DNABaseline and study week 10

    The study team will obtain up to 40 milliliters (ml) of CSF from individuals who weigh at least 60 kilograms, otherwise, they will draw up to 30 ml of CSF. CSF integrated proviral DNA (IPDA and Alu-PCR) will be assessed: Integrated proviral DNA will be performed using existing methods in the clinical research group, which employ the Alu-PCR real-time platform, with a limit of 3 copies. Integrated proviral DNA assay (IPDA) to measure the replication-competent reservoir will be used with digital droplet PCR methodology.