RecruitingPhase 2NCT05452564

Baricitinib for Reduction of HIV - CNS

Phase II Study to Evaluate the Efficacy and Safety of Baricitinib for Reduction of HIV in the Central Nervous System


Sponsor

William Tyor

Enrollment

95 participants

Start Date

May 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

There is still no cure for the human immunodeficiency virus (HIV). While combination antiretroviral therapy (cART) is effective in decreasing deaths from HIV, infected individuals face a lifetime of treatment and many potential complications including end organ diseases such as HIV-associated neurocognitive disorders. HIV infection is controllable with antiretroviral therapy (ART), but ART cannot eliminate HIV reservoirs. Thus, there is no available cure for HIV. There is a large and growing body of evidence that the central nervous system (CNS) is an HIV reservoir site and a barrier to HIV eradication. Our group has done extensive pre-clinical work with janus-kinase (JAK 1/2) inhibitors. This includes baricitinib, which is an orally available, FDA-approved drug for rheumatoid arthritis. Evidence suggests that this drug has activity against HIV in the central nervous system (CNS). In our recently completed pilot study, we showed that baricitinib crosses the blood brain barrier (BBB) and decreases HIV CNS persistence in the brain. Using bloodwork, neurocognitive testing, MRIs and lumbar punctures, we plan to evaluate the change in central nervous system HIV after treatment with baricitinib versus placebo. We will also evaluate changes in neuroimaging, inflammation in blood and cerebrospinal fluid (CSF), and neuropsychological performance after treatment with baricitinib versus placebo. Evidence shows that the central nervous system is one of the reservoir sites that enables the HIV virus to persist in the body even after years of treatment. In order to attack this reservoir and eventually find a cure, it is vital to learn if certain medications can suppress HIV in the CNS.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether baricitinib — a drug that blocks inflammatory signals (JAK inhibitor) typically used for arthritis — can reduce brain inflammation in people living with HIV. HIV can cause ongoing brain inflammation even when the virus is well-controlled, which may contribute to memory problems and mood disorders. **You may be eligible if...** - You are living with HIV and on stable antiretroviral therapy (HIV medications) - Your viral load is undetectable or very low - You have signs of brain inflammation or cognitive symptoms - You are 18 or older **You may NOT be eligible if...** - You have active or untreated serious infections (baricitinib suppresses the immune system) - You have severe kidney or liver disease - You are pregnant or planning to become pregnant - You have a history of blood clots or are at high risk for clotting - You are taking medications that strongly interact with baricitinib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaricitinib 2 MG Oral Tablet

Baricitinib, a Janus Kinase inhibitor drug for viral infections, will be administered orally to subjects randomized to this intervention. The dose will be 2 mg orally for ten weeks. This will be compared with placebo intervention. Follow up visits will take place at week 1,2,4 and 10.

DRUGPlacebo

Patients randomized to the placebo group will receive 2 mg oral daily placebo for ten weeks. Follow up visits will happen for both groups at weeks 1, 2, 4 and 10.


Locations(2)

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

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NCT05452564


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