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ACTIVE NOT RECRUITING
NCT07028385
PHASE2

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

Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

View on ClinicalTrials.gov

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.

Official title: Exploratory Phase 2 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Impact on HIV-1 Reservoir of Baricitinib in Virologically Suppressed People With HIV-1

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-22

Completion Date

2026-07

Last Updated

2026-02-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Bariticinib 2 mg

Commercially available tablets containing 2 mg of barticiinib will be used. The tablets will be re-capsulated to keep the study blind.

OTHER

Placebo

Maltodextrin capsules with identical weight and appearance (shape, size, colour and flavour) as the bariticinib-containing capsules.

Locations (1)

Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain