Can an arthritis drug help clear HIV from the brain?
NCT ID NCT05452564
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether baricitinib, an FDA-approved arthritis drug, can reduce the amount of HIV hiding in the central nervous system. 95 people with HIV on stable antiretroviral therapy will receive either baricitinib or a placebo for 10 weeks. Researchers will measure changes in HIV DNA and RNA in spinal fluid, along with brain scans and thinking tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Baricitinib (an oral tablet used for rheumatoid arthritis, being tested to reduce HIV in the brain)
- What this could lead to
- If successful, this could show that baricitinib helps control HIV in the brain, potentially reducing long-term brain complications and moving toward a future cure.
- What could go wrong
- This is an early Phase 2 trial with only 95 people. It may not show a clear benefit, and baricitinib can have side effects like increased infection risk. Success in the brain does not mean a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 95 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. HIV infected on continuous ART with plasma HIV RNA \<200 copies/ml for at least 12 months (on at least two previous clinic visits and confirmed at screening). If a viral load is documented from a CLIA-certified laboratory 14 days before screening, then this result can be used in place of the screening lab result. 2. Current CD4+ \> 350 cells/microliter for at least twelve months (on at least two previous clinic visits and confirmed at screening). If a CD4 count is documented from a CLIA-certified laboratory 30 days before screening, then this result can be used in place of the screening lab result. 3. Women of reproductive age will have a negative pregnancy test at study entry and agree to contraception while on the study drug. Women who are at least 50 years of age and who have been amenorrheic for at least 12 months will not be required to agree to contraception to participate. Exclusion Criteria: 1. \< 18 years of age or \> 65 years of age 2. Pregnancy or breastfeeding 3. Significant hematological abnormalities at screening (ANC \< 1000, Hgb\<10, platelet\< 100,000) 4. History of progressive multifocal leukoencephalopathy 5. Untreated latent tuberculosis infection (which will be screened for before entry). If there is a prior positive test, the test does not need to be repeated at screening. 6. Immunosuppressive medications (including corticosteroids) and anticoagulants (aspirin acceptable) within 1 month. A partial list is provided in the SOP for staff, but otherwise, if there is a question it will be adjudicated by the Investigator(s). 7. History of deep venous thrombosis 8. Cardiovascular disease: 1. Coronary artery disease or history of myocardial infarction, no exclusion if greater than 3 months 2. Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines-- no exclusion if greater than 3 months 3. Ever a history of stroke 9. Hematologic malignancies including lymphoma and leukemia which have no evidence of cure or are at least in remission for \> 5 years 10. Major surgery within 8 weeks before screening or will require major surgery during the study 11. Current or recent (\<4 weeks before randomization) clinically serious viral (including COVID-19), a bacterial, fungal, or parasitic infection or any other active or recent infection. History of untreated syphilis infection. If an RPR was negative in the 3 months before screening, then an RPR is not needed at screening 12. Symptomatic herpes simplex at the time of randomization 13. Symptomatic herpes zoster infection within 12 weeks before randomization. 14. History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement). 15. Positive test for hepatitis B virus (HBV) defined as: 1. positive for hepatitis B surface antigen (HBsAg), or 2. positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) 16. Hepatitis C virus (HCV) chronic infection (hepatitis C antibody-positive and HCV ribonucleic acid \[RNA\]-positive), ever. 17. Cirrhosis of the liver from any cause 18. Any of the following specific abnormalities on screening laboratory tests: 1. ALT or AST \>2 x upper limits of normal (ULN) 2. alkaline phosphatase (ALP) ≥2 x ULN 3. total bilirubin ≥1.5 x ULN (except patients on atazanavir, who must have total bilirubin \<2 x ULN) 4. International Normalized Ratio (INR) \> 1.5 5. Absolute Neutrophil Count (ANC) \<1000 cells/mm3, confirmed on repeat testing. 19. Chronic kidney disease with eGFR \<40 mL/min/1.73 m2 (note that the dose of baricitinib will be reduced to 1 mg daily in participants with GFR between 40 and 60). Specifically, the CKD-EPI without race-based equation is used 20. Current dependence on illicit drugs except for marijuana 21. Bleeding disorders such as Von Willebrand's Disease, hemophilia, or other coagulopathies as determined by history. 22. Any evidence of a mass lesion by history that could lead to increased intracranial pressure and evidence of trauma to the lumbar vertebra (see LP exclusion criteria above) by history. - no lumbar trauma or surgery in the last 60 days, but this will be adjudicated by Investigator(s) if need be. 23. Population: The study team will not include any of the following groups: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
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Grady Memorial Hospital
RECRUITINGAtlanta, Georgia, 30303, United States
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