Safety and Impact of Baricitinib on Cell Surivival Pathways, HIV-1 Reservoir and Inflamation in People With HIV-1

• Status: NOT_YET_RECRUITING
• Trial end date: 2026-04-01

Summary

The goal of this exploratory clinical trial is to evaluate the safety and tolerability of bariticinib administered at 2 mg once daily during 12 weeks in 30 people living with HIV-1 (PWH) on suppressive antiretroviral therapy (ART) and to evaluate changes in levels of phosphorylated STAT (pSTAT) after 12 weeks of treatment with bariticinib. The main questions it aims to answer are:

• The safety and tolerability of bariticinib
• To evaluate the effects of bariticinib on T-cells (HIV-1 reservoirs, apoptosis, inflamation, activation and exhaustion).
• To characterize bariticinib pharmacokinetics in plasma.

Participants will be treated with pral Barticinib 2mg or matched Placebo daily for 12 weeks. Suppressive cART will remain unchanged during the entire study. Participants will be followed until week 24, in a total of 8 visits.

• Phase: PHASE2

Details

• Lead Sponsor: Fundacin FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promocin de la Salud y la Ciencia
• Collaborators: Germans Trias i Pujol Hospital; Instituto de Salud Carlos III; IrsiCaixa; University of Turin, Italy