Safety and Impact of Baricitinib on Cell Surivival Pathways, HIV-1 Reservoir and Inflamation in P… (NCT07028385) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety and Impact of Baricitinib on Cell Surivival Pathways, HIV-1 Reservoir and Inflamation in People With HIV-1
Spain30 participantsStarted 2025-09-22
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females aged between 18 and 65 years on the day of screening visit.
* Confirmed HIV-1 infection.
* Receiving suppressive cART for at least 2 years (defined as maintained plasma viral load \<50 copies/mL, allowing for isolated blips \[\<200 cop/ml, non-consecutive, representing \<20% total determinations\]).
* Being on the same cART regimen within at least 4 weeks prior to baseline visit (week 0).
* Willing and able to be adherent to their cART regimen for the duration of the study.
* Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
* In the opinion of the clinical Investigator, the candidate has understood the information provided and can give written Informed Consent.
* If heterosexually active female of childbearing potential using an effective method of contraception different from hormonal contraception (intra-uterine device (IUD), anatomical sterility in self or partner or sexual abstinence) from 14 days prior to the first IMP administration and commit to use it until 3 months after the last IMP administration. All female candidates of childbearing potential who are not sexually active with men at screening, must agree to utilize an effective method of contraception if they become sexually active during the study.
* If female of childbearing potential, willing to undergo urine pregnancy tests at the designated time points.
* If positive IgG for varicella zoster, ade…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of baricitinib.
Timeframe: From baseline (week 0) to week 12
2
To evaluate changes in levels of phosphorylated STAT (pSTAT) in CD4+ T cells, as a pharmacodynamic biomarker of baricitinib activity.
Timeframe: From baseline (week 0) to week 12
Trial details
NCT IDNCT07028385
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia