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Baricitinib Curative Repression of HIV-1
Sponsor: 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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-03
Completion Date
2028-01
Last Updated
2026-02-23
Healthy Volunteers
Yes
Conditions
Interventions
Antiretroviral Therapy (ART)
Antiretroviral Therapy (ART): A treatment regimen for HIV infection that uses a combination of antiretroviral drugs to suppress viral replication, reduce HIV-related morbidity, and prevent transmission. In Step 1, participants will continue their current ART regimen for 26 weeks. In Step 2, participants will interrupt ART. In Step 3, participants will restart ART treatment early if they meet the ART restart criteria before the end of Step 2 (24-week maximum). Otherwise, they will resume ART at the end of Step 2.
Baricitinib (LY3009104) 2 mg
Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. During Step 1, Baricitinib will be taken at a dose of 2 mg orally daily for 26 weeks. During Step 2, Baricitinib alone will be continued at a dose of 2 mg orally daily for up to an additional 24 weeks
Locations (2)
Grady Infectious Diseases Clinic (Ponce Center)
Atlanta, Georgia, United States
Dr. Gavegnano's Laboratory
Atlanta, Georgia, United States