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Can an arthritis drug keep HIV in check without daily pills?

NCT ID NCT07209267

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Dr. Gavegnano's Laboratory

    Atlanta, Georgia, 30322, United States

  • 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.