Baricitinib Curative Repression of HIV-1
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEmory University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
< 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.
Trial design
Treatments tested in this trial
- Antiretroviral Therapy (ART)
- Baricitinib (LY3009104) 2 mg
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Emory University
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov