Baricitinib Curative Repression of HIV-1

Emory University

Status and phase: Not yet enrolling; Phase 2

Conditions: HIV; HIV Infection

Treatments: Drug: Antiretroviral Therapy (ART); Drug: Baricitinib (LY3009104) 2 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07209267

2025P012728 (Other Identifier)

STUDY00009759

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Baricitinib

Experimental group

Description:

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).

Treatment:

Drug: Baricitinib (LY3009104) 2 mg

Drug: Antiretroviral Therapy (ART)