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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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 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
Grady Infectious Diseases Clinic (Ponce Center)
Atlanta, Georgia, United States
Dr. Gavegnano's Laboratory
Atlanta, Georgia, United States
Time to restart ART
Time to restart ART will be defined by a plasma HIV-1 RNA viral load greater than or equal to 1000 copies/mL following withdrawal of ART during 24 weeks of baricitinib treatment alone (following 26 weeks of baricitinib plus ART).
Time frame: Up to 24 weeks after the baricitinib treatment alone was started
Number of Participants who discontinued treatment due to adverse events
Participants who permanently discontinued study drug due to treatment-related adverse events.
Time frame: Up to 24 weeks after the start of baricitinib alone was started
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events.
Time frame: Up to 24 weeks after the start of baricitinib alone was started
Time to a detectable plasma HIV-1 RNA viral load
Time to a detectable plasma HIV-1 RNA viral load (defined as greater than the lower limit of quantification) after analytic treatment Interruption (ATI).
Time frame: Up to 24 weeks after baricitinib alone was started.
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