Phase 2 Study to Test Baricitinibs Ability to Reduce HIV in the Brain of Adults on Antiretroviral Therapy

What this Trial Is About

This research aims to evaluate the effects of baricitinib, an oral Janus Kinase inhibitor, on the persistence of HIV in the central nervous system CNS. Despite effective antiretroviral therapy controlling HIV in the body, HIV reservoirs remain in the CNS, preventing a cure. The study focuses on whether baricitinib can reduce HIV levels in the brain and improve neurocognitive function, inflammation, and neuroimaging markers compared to placebo in people living with HIV who have durable viral suppression on ART. Participants will be randomly assigned to receive either baricitinib 2 mg orally once daily or a matching placebo for ten weeks. Both groups will have follow-up visits at weeks 1, 2, 4, and 10 to monitor treatment effects. Baricitinib has been shown in preclinical studies to cross the blood-brain barrier and reduce HIV in the CNS, making it a promising candidate for targeting HIV reservoirs in the brain. During the study, participants will undergo blood tests, neurocognitive assessments, MRI scans, and lumbar punctures at the start and end of the treatment period to measure HIV levels in the cerebrospinal fluid and blood. Researchers will evaluate changes in integrated HIV DNA, HIV RNA, inflammatory markers, and neuropsychological performance. Safety and tolerability will be closely monitored, and the total participation duration is approximately ten weeks.

Baricitinib for Reduction of HIV - CNS