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NCT05452564

Baricitinib for Reduction of HIV- CNS

Phase II Study to Evaluate the Efficacy and Safety of Baricitinib for Reduction of HIV in the Central Nervous System
Emory University·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Human Immunodeficiency Virus
Drug/Device/Intervention
Baricitinib 2 MG Oral Tablet
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Emory University
Location
Atlanta,Atlanta, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Oct 01, 2022
End date
Sep 01, 2027
Enrollment
95 participants
Primary outcome

Changes in CSF HIV cell associated RNA by Double-R assay,Changes in CSF HIV cell associated CSF HIV DNA by Double-R assay,Changes in CSF cell associated DNA,Changes in CSF integrated proviral DNA,Changes in CSF HIV RNA by single copy assay,Changes in HIV tat protein in CSF,Changes in HIV specific T cells in CSF,Changes in CSF HIV antibodies by LIPS assay,Changes in CSF CXCL10,Changes in CSF Neopterin,Changes in CSF IL-7,Changes in CSF IL-15,Changes in CSF Microtubule association protein-2

Summary

There is still no cure for the human immunodeficiency virus (HIV). While combination
 antiretroviral therapy (cART) is effective in decreasing deaths from HIV, infected
 individuals face a lifetime of treatment and many potential complications including end organ
 diseases such as HIV-associated neurocognitive disorders. HIV infection is controllable with
 antiretroviral therapy (ART), but ART cannot eliminate HIV reservoirs. Thus, there is no
 available cure for HIV. There is a large and growing body of evidence that the central
 nervous system (CNS) is an HIV reservoir site and a barrier to HIV eradication. Our group has
 done extensive pre-clinical work with janus-kinase (JAK 1/2) inhibitors. This includes
 baricitinib, which is an orally available, FDA-approved drug for rheumatoid arthritis.
 Evidence suggests that this drug has activity against HIV in the central nervous system
 (CNS). In our recently completed pilot study, we showed that baricitinib crosses the blood
 brain barrier (BBB) and decreases HIV CNS persistence in the brain.
 
 Using bloodwork, neurocognitive testing, MRIs and lumbar punctures, we plan to evaluate the
 change in central nervous system HIV after treatment with baricitinib versus placebo. We will
 also evaluate changes in neuroimaging, inflammation in blood and cerebrospinal fluid (CSF),
 and neuropsychological performance after treatment with baricitinib versus placebo.
 
 Evidence shows that the central nervous system is one of the reservoir sites that enables the
 HIV virus to persist in the body even after years of treatment. In order to attack this
 reservoir and eventually find a cure, it is vital to learn if certain medications can
 suppress HIV in the CNS.

ICD-10 classifications
Human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesAsymptomatic human immunodeficiency virus [HIV] infection status
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05452564
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05452564 through Pure Global AI's free database. This Phase 2 trial is sponsored by Emory University and is currently Not yet recruiting. The study focuses on Human Immunodeficiency Virus. Target enrollment is 95 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.