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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fwirjiatj Fmj Da Lspqi Cucxmb Ed Syaz Lnd Ekaysywdaomh Iqthdgijzpj Y Lm Plffnjdes Dq Ll Sqvdy Y Lz C	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	02.06.2025

Trial locations

Investigated drugs:

Baricitinib

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.

Investigated diseases:

HIV infection

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 ID:

2024-520159-26-00

Protocol code:

BCN05-Bari

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?