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Baricitinib Curative Repression of HIV-1
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.
Details
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 20 |
| Start date | 2026-07 |
| Completion | 2028-01 |
Conditions
- HIV Infection
- HIV
Interventions
- Antiretroviral Therapy (ART)
- Baricitinib (LY3009104) 2 mg
Primary outcomes
- Time to restart ART — Up to 24 weeks after the baricitinib treatment alone was started
Time to restart ART will be defined by a plasma HIV-1 RNA viral load greater than or equal to 1000 copies/mL following withdrawal of ART during 24 weeks of baricitinib treatment alone (following 26 weeks of baricitinib plus ART). - Number of Participants who discontinued treatment due to adverse events — Up to 24 weeks after the start of baricitinib alone was started
Participants who permanently discontinued study drug due to treatment-related adverse events. - Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to 24 weeks after the start of baricitinib alone was started
Number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events.
Countries
United States