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Baricitinib Curative Repression of HIV-1 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Baricitinib Curative Repression of HIV-1

NCT07209267•Emory University

Summary

This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Researchers will test the effects of continuing baricitinib in people with HIV before and after discontinuing their antiretroviral therapy. This drug is approved by the Food and Drug Administration (FDA) for other diseases; it is not approved for the treatment of HIV-1. The study team will also investigate any side effects associated with the drug.

Detailed Description

This study will test whether the medication baricitinib, which reduces inflammation and is already approved for other diseases, can delay the return of HIV after stopping antiretroviral therapy (ART). The goal is to see if baricitinib can safely reduce inflammation and the HIV that is hidden in the body. The study will include adults with HIV who have a suppressed viral load on ART. Participants will receive ART combined with baricitinib for 26 weeks, followed by baricitinib alone after stopping ART. If the virus returns, the previous ART will be restarted. Each participant will be involved in the study for approximately 12 to 18 months. Blood and other biological samples may be stored for future research use, with the participant's consent.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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 may 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
+5 more criteria

Locations (2)

Grady Infectious Diseases Clinic (Ponce Center)

Atlanta, Georgia, United States

Dr. Gavegnano's Laboratory

Atlanta, Georgia, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

HIV InfectionHIV

Interventions

Antiretroviral Therapy (ART)

DRUG

Baricitinib (LY3009104) 2 mg

DRUG

Contacts

Vincent Marconi, MD

CONTACT

404-616-0673 vcmarco@emory.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Baricitinib Curative Repression of HIV-1

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