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Study on the Safety and Effects of Baricitinib in People with HIV

Registered drug
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called baricitinib on people living with HIV-1, a virus that attacks the immune system. The study aims to evaluate the safety and impact of baricitinib, which is taken as a 2 mg film-coated tablet once daily. Baricitinib is also known by its code names LY-3009104 and INCB-028050. Participants in the study will either receive baricitinib or a placebo, which looks like the real medication but does not contain the active ingredient.

The purpose of the study is to assess how safe baricitinib is for people with HIV-1 who are already on a stable treatment plan that keeps the virus under control. The study will also look at how baricitinib affects certain cells in the immune system, specifically CD4+ T cells, which are important for fighting infections. Participants will take the medication for 12 weeks, and their health will be monitored through regular blood tests and check-ups to ensure their safety and to observe any changes in their immune system.

Throughout the study, researchers will measure various markers in the blood to understand how baricitinib affects the body. These markers include levels of certain proteins and the amount of HIV-1 DNA in the cells. The study will help determine if baricitinib can be a safe and effective addition to the current treatment options for people living with HIV-1. Participants will be closely monitored for any side effects or changes in their health during the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be required to provide written informed consent, confirming their understanding of the study and willingness to participate.

    Participants must meet specific criteria, including being between 18 and 65 years old, having a confirmed HIV-1 infection, and being on a stable antiretroviral therapy (cART) regimen for at least two years.

  2. Step 2

    Initial visit and baseline assessments

    At the initial visit, participants will undergo baseline assessments, including blood draws and other tests to evaluate their current health status.

    Participants will begin taking the study medication, baricitinib, at a dose of 2 mg once daily, administered orally as a film-coated tablet.

  3. Step 3

    Medication administration

    Participants will continue taking baricitinib 2 mg once daily for a duration of 12 weeks.

    It is important to adhere to the medication schedule and take the tablet at the same time each day.

  4. Step 4

    Follow-up visits and assessments

    Follow-up visits will occur at weeks 4, 12, and 24 to monitor the participant's health and response to the medication.

    During these visits, blood samples will be collected to assess safety and measure specific biomarkers related to the study.

  5. Step 5

    Completion of medication phase

    After 12 weeks, participants will complete the medication phase of the study.

    Participants will continue to be monitored for any changes in health or laboratory results until the end of the study period.

  6. Step 6

    Final assessments and study conclusion

    At the end of the study, participants will undergo final assessments to evaluate the overall impact of the medication on their health.

    The study is expected to conclude by June 2026, with all data collected and analyzed to determine the safety and effects of baricitinib in people with HIV-1.

Who can join the trial?

11 criteria

  • Males and females aged between 18 and 65 years on the day of the screening visit.
  • If you have a positive test for **IgG for varicella zoster** (a type of antibody indicating past infection or vaccination), you must have had a **herpes zoster vaccination** (shingles vaccine) at least 4 weeks before the start of the study.
  • Willing to have blood drawn at specific times during the study.
  • Confirmed **HIV-1 infection**.
  • Receiving **suppressive cART** (combination antiretroviral therapy) for at least 2 years, which means maintaining a low level of the virus in the blood (plasma viral load <50 copies/mL), with occasional small increases allowed.
  • On the same cART regimen for at least 4 weeks before the start of the study.
  • Willing and able to stick to their cART regimen for the entire study.
  • Willing to follow the study requirements and available for follow-up for the entire study duration.
  • Understands the study information and can give written **Informed Consent** (agreement to participate after understanding the study details).
  • If a sexually active female who can have children, using an effective method of **contraception** (birth control) that is not hormonal, such as an **intra-uterine device (IUD)**, being surgically sterile, or practicing sexual abstinence, starting 14 days before the first study medication and continuing until 3 months after the last dose. If not sexually active with men at the start, must agree to use effective contraception if becoming sexually active during the study.
  • If a female who can have children, willing to take urine pregnancy tests at specific times during the study.

Who cannot join the trial?

7 criteria

  • Having an active infection with the Human Immunodeficiency Virus (HIV), which is a virus that attacks the body's immune system.
  • Not being on a stable treatment plan for HIV, known as suppressive ART (Antiretroviral Therapy), which is a medication regimen that helps control the virus.
  • Being under the age of 18 or over the age of 65.
  • Being pregnant or breastfeeding.
  • Having a history of severe allergic reactions to medications similar to the study drug.
  • Having any other medical condition that the study doctors believe would make it unsafe to participate.
  • Participating in another clinical trial at the same time.
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Investigated drugs

Baricitinib is a medication being studied for its potential effects on people living with HIV-1 who are already on treatment that keeps the virus under control. In this trial, researchers are looking at how safe and tolerable baricitinib is when taken daily for 12 weeks. They are also interested in seeing how baricitinib affects certain cells in the immune system, specifically CD4+ T cells, by measuring a marker called phosphorylated STAT (pSTAT). This study aims to understand if baricitinib can have an impact on the HIV-1 reservoir, which is the part of the virus that remains in the body even when the virus is suppressed by other treatments.

What is already known about the treatment

Baricitinib – Baricitinib is taken orally in the form of a tablet, typically administered once daily. It is currently being studied in clinical trials for its potential use in people with HIV-1 who are already on suppressive antiretroviral therapy (ART). The main therapeutic indication being explored is its ability to impact the HIV-1 reservoir in the body. At the molecular level, baricitinib works by inhibiting certain enzymes called Janus kinases (JAKs), which play a role in the signaling pathways that affect immune cell function. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Human Immunodeficiency Virus (HIV) – HIV is a virus that attacks the body's immune system, specifically the CD4 cells (T cells), which are crucial for fighting infections. Over time, HIV can destroy so many of these cells that the body becomes unable to fight off infections and disease. The virus progresses through several stages, starting with acute infection, where flu-like symptoms may occur. This is followed by a chronic stage, where the virus multiplies at lower levels and may not cause symptoms. Without treatment, HIV can advance to acquired immunodeficiency syndrome (AIDS), the most severe phase, where the immune system is severely damaged. During this stage, individuals are at risk for opportunistic infections and certain cancers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520159-26-00Protocol codeBCN05-BariEstimated enrolment30 patientsSponsorFundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia

sourced from the EU Clinical Trials Register and site verification

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