[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609031":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":39,"locations":45,"responsibleParty":65,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":43,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":43,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":93,"whyStopped":43,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Emory University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Baricitinib","EXPERIMENTAL","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).\n\nFollowing 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).\n\nIf 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).",[13,14],"Drug: Antiretroviral Therapy (ART)","Drug: Baricitinib (LY3009104) 2 mg",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Antiretroviral Therapy (ART)","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.\n\nIn Step 1, participants will continue their current ART regimen for 26 weeks.\n\nIn Step 2, participants will interrupt ART.\n\nIn 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.",[9],[22],"Standard of Care",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Baricitinib (LY3009104) 2 mg","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.\n\nDuring Step 1, Baricitinib will be taken at a dose of 2 mg orally daily for 26 weeks.\n\nDuring Step 2, Baricitinib alone will be continued at a dose of 2 mg orally daily for up to an additional 24 weeks",[9],[28],"Olumiant",[30,33,35,37],{"name":31,"affiliation":5,"role":32},"Vincent Marconi, MD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":32},"William Tyor, MD",{"name":36,"affiliation":5,"role":32},"Christina Gavegnano, PhD",{"name":38,"affiliation":5,"role":32},"Andrew H Miller, MD",[40],{"name":31,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","404-616-0673",null,"vcmarco@emory.edu",[46,59],{"facility":47,"status":43,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":43},"Grady Infectious Diseases Clinic (Ponce Center)","Atlanta","Georgia","30308","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-84.38798,33.749,{"lat":57,"lon":56},{"facility":60,"status":43,"city":48,"state":49,"zip":61,"country":51,"countryCode":52,"cosmosGeoPoint":62,"geoPoint":64,"contacts":43},"Dr. Gavegnano's Laboratory","30322",{"type":54,"coordinates":63},[56,57],{"lat":57,"lon":56},{"type":32,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Vincent Marconi","Professor of Medicine",[69],{"name":70,"class":71},"Eli Lilly and Company","INDUSTRY","100609031","phase-2-baricitinib-curative-repression-of-hiv-1-100609031",false,"NCT07209267","Baricitinib Curative Repression of HIV-1","Inclusion Criteria:\n\n* Documented HIV infection\n* 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.\n* Plasma HIV-1 RNA levels of \\\u003C50 copies\u002FmL for at least 96 weeks (a minimum of two measures), and \\\u003C50 copies\u002FmL for a sample obtained within 90 days, before enrollment.\n* CD4+ T-cell count ≥500 cells\u002Fmm3 obtained within 90 days prior to enrollment\n* No known history of CD4+ T-cell count nadir \\\u003C200 cells\u002Fmm3\n* Negative pregnancy test at time of study enrollment\n* Additional laboratory criteria may apply.\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age or \\> 70 years of age\n* Pregnancy or breastfeeding, as determined by a blood pregnancy test\n* History of AIDS-defining illness, except for recurrent pneumonia.\n* History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease.\n* 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.\n* 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.\n* History of deep venous thrombosis\n* 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)\n* History of HIV-associated malignancy, including Kaposi's sarcoma, or any lymphoma\u002Fleukemia or virus-associated cancers. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months\n* Major surgery within 8 weeks before screening, or will require major surgery during the study\n* Current or recent (\\\u003C4 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\n* Symptomatic herpes simplex at the time of screening.\n* Symptomatic herpes zoster infection within 12 weeks before screening.\n* History of disseminated\u002Fcomplicated herpes zoster (for example, ophthalmic zoster or central nervous system (CNS) involvement).\n* Positive test for hepatitis B virus (HBV)\n* Additional exclusion criteria apply",true,"ALL","18 Years","70 Years",{"count":83,"type":84},20,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","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.",[90,91],"HIV Infection","HIV",[9,18],"NOT_YET_RECRUITING","2026-04-15",{"date":96,"type":97},"2026-04-20","ACTUAL",{"date":99,"type":84},"2026-07",{"date":101,"type":84},"2028-01",{"name":5,"class":6},2]