Can an arthritis drug keep HIV in check without daily pills?
NCT ID NCT07209267
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This study tests whether baricitinib, an FDA-approved drug for other conditions, can keep HIV under control after participants stop their usual antiretroviral therapy (ART). Twenty people with well-controlled HIV will take baricitinib alongside ART for 26 weeks, then continue baricitinib alone for up to 24 weeks. The goal is to see if baricitinib delays viral rebound and reduces the need to restart ART.
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 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- 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 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Documented HIV infection * On continuous ART for at least 96 weeks before enrollment, with no interruption of ART for 7 consecutive days or longer in the 48 weeks before enrollment. * Plasma HIV-1 RNA levels of \<50 copies/mL for at least 96 weeks (a minimum of two measures), and \<50 copies/mL for a sample obtained within 90 days before enrollment. * CD4+ T-cell count ≥500 cells/mm3 obtained within 90 days prior to enrollment * No known history of CD4+ T-cell count nadir \<200 cells/mm3 * Negative pregnancy test at time of study enrollment * Additional laboratory criteria apply. Exclusion Criteria: * \< 18 years of age or \> 70 years of age * Pregnancy or breastfeeding, as determined by a blood pregnancy test * History of AIDS-defining illness, except for recurrent pneumonia. * History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease. * 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. * History of use of any immunomodulatory medications within 6 months before enrollment, including systemic corticosteroids (\>14 days), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immunomodulatory effect. * 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, history of stroke) * History of HIV-associated malignancy, including Kaposi's sarcoma, or any lymphoma/leukemia or virus-associated cancers. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months * Major surgery within 8 weeks before screening, or will require major surgery during the study * Current or recent (\<4 weeks before screening) clinically serious viral (including COVID-19), bacterial, fungal, or parasitic infection or any other active or recent infection. History of untreated syphilis infection. If a rapid plasma reagin (RPR) test was negative in the 3 months before screening, then an RPR is not needed at screening * Symptomatic herpes simplex at the time of screening. * Symptomatic herpes zoster infection within 12 weeks before screening. * History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or central nervous system (CNS) involvement). * Positive test for hepatitis B virus (HBV) * Additional exclusion criteria apply
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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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Dr. Gavegnano's Laboratory
Atlanta, Georgia, 30322, United States
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Grady Infectious Diseases Clinic (Ponce Center)
Atlanta, Georgia, 30308, United States
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Other studies related to the condition(s) this trial covers.
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