Baricitinib Curative Repression of HIV-1

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07209267
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Antiretroviral Therapy (ART) — DRUG
    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 — DRUG
    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

Study Details

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 Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Adults with well-controlled HIV on ART will be treated for 26 weeks with baricitinib 2 mg per day orally plus their current ART regimen (Step 1). Following 26 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 24 weeks (Step 2). If a participant qualifies for ART restart criteria before the end of the maximum 24 weeks of Step 2, they will move to Step 3 early and resume ART, while baricitinib will be discontinued for 24 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 24 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 24 weeks of observation (Step 3).

Primary Outcome Measure

Time to restart ART [ Time Frame: Up to 24 weeks after the baricitinib treatment alone was started ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dr. Gavegnano's LaboratoryAtlantaGeorgia30322-
Grady Infectious Diseases Clinic (Ponce Center)AtlantaGeorgia30308-

Find similar trials in Atlanta, GA

By condition
HIV
By specialty
Infectious disease
By research site
Dr. Gavegnano's Laboratory· Atlanta, GAGrady Infectious Diseases Clinic (Ponce Center)· Atlanta, GA

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