Baricitinib Curative Repression of HIV-1

Prior treatment

• 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.
• 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 zoster infection within 12 weeks before screening.

Other illness

• History of AIDS-defining illness, except for recurrent pneumonia.
• History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease.
• History of deep venous thrombosis
• 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
• History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or central nervous system (CNS) involvement).
• Positive test for hepatitis B virus (HBV)

Lab values

• 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)

Age

• \< 18 years of age or \> 70 years of age

Other

• Pregnancy or breastfeeding, as determined by a blood pregnancy test
• Symptomatic herpes simplex at the time of screening.
• Additional exclusion criteria apply

• 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 apply.