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Baricitinib Curative Repression of HIV-1

NCT07209267

Not Yet RecruitingPhase 2

Sponsor: Emory University

Conditions: HIV Infection, HIV

Interventions: Antiretroviral Therapy (ART), Baricitinib (LY3009104) 2 mg, Baricitinib (LY3009104) 4 mg

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Atlanta, Georgia, United States
Atlanta, Georgia, United States