HIVPhase 2NCT07028385

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

A Phase 2 study testing Bariticinib 2 mg in people with HIV, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: HIV
What is being tested?: Bariticinib 2 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteSpain
Study dates: 22 Sep 2025to 30 Jun 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

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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, adequate herpes zoster vaccination at least 4 weeks prior to week 0 visit.
Willing to accept blood draws at time points specified in the Schedule of Events.

Who cannot join

If female of childbearing potential, pregnant or planning a pregnancy during the entire study or lactating.
Prior history or clinical manifestations of any physical or psychiatric disorder that could impair the subject's ability to complete the study.
Any active AIDS-defining disease or progression of HIV-related disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy.
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal, or penile intraepithelial neoplasia.
Systemic treatment for cancer within 1 year of study entry.
Known hypersensitivity to any component of the IMP formulation, or severe or multiple allergies to drugs or pharmaceutical agents.

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Potential participant received or plans to receive:
Licensed live attenuated vaccines within 28 days before or after inflammation and immune biomarkers visit (weeks 0 and 12).
Other vaccines (eg, tetanus, hepatitis A, hepatitis B, rabies, pneumococcal, recombinant Herpes Zoster, Influenza, COVID-19 vaccines) within 14 days before or after inflammation and immune biomarkers visits (weeks 0 and 12).
Receipt of blood products within 3 months of study entry.
Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents (use on inhaled steroids for asthma or topic steroids for localized skin conditions are permitted).
Any other current or prior therapy which, in the opinion of the investigator, would make the individual unsuitable for the study or influence the results of the study.
Prior history of thrombotic events (deep venous thrombosis, pulmonary embolism, or arterial thrombosis) or known inherited prothrombotic disorders (Factor V Leiden, prothrombin G2021A mutation, antithrombin deficiency, protein S deficiency, protein C deficiency, etc).
Current use of combined hormonal contraceptives or substitutive hormonal treatment.
History of any of the following cardiovascular diseases: myocardial infarction, unstable angina, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months.
Current smokers over 10 cigarettes per day or former smokers with a history of smoking more than 10 packyears, unless they quit smoking more than 15 years ago.
Positive hepatitis C IgG, unless confirmed clearance of HCV infection (undetectable plasma viral load, spontaneous or following treatment).
Chronic hepatitis B, defined as positive hepatitis B surface antigen (HBsAg); or past hepatitis B, defined as positive hepatitis B core antibody (HBcAb), unless ART regimen contains FTC/TFV during the study.
Symptomatic herpes zoster or recurrent genital herpes within 24 weeks, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or CNS zoster.
History of active, past, or latent tuberculosis, confirmed through medical history, clinical records, or a positive TB IGRAs by QuantiFERON test, unless documented preventive TB treatment with 6 or 9 months of daily isoniazid, or a 3-month regimen of weekly rifapentine plus isoniazid, or a 3-month regimen of daily isoniazid plus rifampicin.
Any laboratory abnormalities including:
Hematology
Hemoglobin <10.0 g/dl,
Absolute neutrophil count ≤1,000 /mm3,
Absolute lymphocyte count ≤500 /mm3,
Platelets >450,000/mm3, Biochemistry
eGFR <30 ml/min,
AST > 2.5 x ULN,
ALT > 2.5 x ULN,

Trial locations and contacts

1 site in 1 country.

Spain1 site

Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916

Other trials in Spain

About this study

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

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.

Read the detailed description

Despite the success of antiretroviral therapy (ART) in suppressing HIV replication, it does not eliminate the latent viral reservoir, which remains a major barrier to achieving a cure. Recent evidence suggests that HIV-infected cells may evade immune clearance by overexpressing anti-apoptotic proteins such as BCL-2, contributing to reservoir persistence. Baricitinib, a second-generation Janus kinase (JAK) inhibitor has shown potential in preclinical studies to reduce HIV reactivation and modulate immune activation.

This study investigates whether baricitinib can safely modulate the HIV-1 reservoir and immune environment in PWH on suppressive ART.

Participants will be randomized (2:1) to receive either oral baricitinib 2 mg or placebo daily for 12 weeks, followed by a 12-week observation period.

The primary objectives are to assess the safety and tolerability of baricitinib and to evaluate changes in phosphorylated STAT (pSTAT) levels in CD4+ T cells as a pharmacodynamic marker.

Secondary objectives include evaluating the effects of baricitinib on BCL-2 expression, JAK/STAT signaling, HIV-1 reservoir size, inflammatory biomarkers, and immune cell subsets.

Exploratory analyses will assess HIV-specific T cell responses, CD4+ T cell susceptibility to cytotoxic T lymphocyte (CTL) killing, and transcriptomic changes.

Conditions: HIV
Being tested: Bariticinib 2 mg, Placebo
Keywords: bariticinib, HIV, ctl resistance, jak/stat inhibitor, bcl2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bariticinib 2 mgDrug
Commercially available tablets containing 2 mg of barticiinib will be used. The tablets will be re-capsulated to keep the study blind.
PlaceboOther
Maltodextrin capsules with identical weight and appearance (shape, size, colour and flavour) as the bariticinib-containing capsules.

Study groups in NCT07028385
Study group	Role	What they receive
Bariticinib	Experimental	Participants will take one capsule containing 2 mg of baricitinib, once daily, oral administration for 12 weeks Receives: Drug: Bariticinib 2 mg
Placebo	Placebo comparator	Participants will take one capsule containing inert substance (maltodextrine), once daily, oral administration for 12 weeks. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the safety and tolerability of baricitinib.
Proportion of participants developing Grade 3 or 4 treatment-related adverse events or laboratory abnormalities during the study, based on the Division of AIDS (DAIDS) Table for grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 [July 2017].
Measured: From baseline (week 0) to week 12
To evaluate changes in levels of phosphorylated STAT (pSTAT) in CD4+ T cells, as a pharmacodynamic biomarker of baricitinib activity.
Levels of pSTAT 1, 3 and 5 in CD4+ T cells measured by Flow cytometry.
Measured: From baseline (week 0) to week 12

Secondary outcomes (6)

To evaluate the effect of baricitinib on proapoptotic pathways mediated by BCL-2.
Changes in levels of BCL-2 in CD4+ T cells measured by Flow cytometry.
Measured: From baseline (week 0) to week 12
To evaluate the effect of baricitinib on JAK/STAT signaling pathway
Changes in levels of IFITM2, pJAK1/2, cleaved-caspase 3 and other proapoptotic markers in CD4+ T cells measured by Western blot.
Measured: From baseline (week 0) to week 12
To evaluate the effect of baricitinib on the HIV-1 reservoir.
Changes in total and intact proviral HIV-1 DNA (IPDA) in CD4 T cells.
Measured: From baseline (week 0) to week 12
To evaluate the impact of baricitinib on homeostatic cytokines, inflammatory biomarkers and cell death markers.
Changes in soluble plasma levels of proinflammatory biomarkers (such as IL-2, IL-6, IL-7, IL-15, IL-8, TNFa, IFNg and sCD14) and anti-inflammatory biomarkers (such as IL-10, IL-4, IL-13).
Measured: From baseline (week 0) to week 12
To evaluate the effects of baricitinib in immune cell subsets.
Changes in T cell immune subsets and frequencies of T cells expressing activation, exhaustion and senescence markers measured by multiparametric flow cytometry.
Measured: From baseline (week 0) to week 12
To characterize baricitinib pharmacokinetics in plasma.
Baricitinib concentrations in plasma
Measured: From week 4 to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 202530 Jun 2026

First posted19 Jun 2025
Study start22 Sep 2025
Primary completion9 Apr 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized 2:1 to the 2 arms: Bariticinib arm VS Placebo arm
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07028385
Sponsor's protocol ID: BCN05-Bari
Other IDs: 2024-520159-26-00
Status last verified: Jun 2026
First submitted: 11 Jun 2025
Last updated: 6 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The individual participant data (IPD) will not be shared publicly due to the exploratory nature of the trial, the limited sample size, and the sensitive nature of the data related to HIV status and immunological profiling.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07028385
Acronym / sponsor ID: BCN05-Bari
Conditions: HIV
Keywords: bariticinib, HIV, ctl resistance, jak/stat inhibitor, bcl2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
Collaborators: IrsiCaixa, University of Turin, Italy, Instituto de Salud Carlos III, Germans Trias i Pujol Hospital
Study start: 22 Sep 2025 (actual)
Primary completion: 9 Apr 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 19 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

This study investigates whether baricitinib can safely modulate the HIV-1 reservoir and immune environment in PWH on suppressive ART.

Participants will be randomized (2:1) to receive either oral baricitinib 2 mg or placebo daily for 12 weeks, followed by a 12-week observation period.

The primary objectives are to assess the safety and tolerability of baricitinib and to evaluate changes in phosphorylated STAT (pSTAT) levels in CD4+ T cells as a pharmacodynamic marker.

Secondary objectives include evaluating the effects of baricitinib on BCL-2 expression, JAK/STAT signaling, HIV-1 reservoir size, inflammatory biomarkers, and immune cell subsets.

Exploratory analyses will assess HIV-specific T cell responses, CD4+ T cell susceptibility to cytotoxic T lymphocyte (CTL) killing, and transcriptomic changes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized 2:1 to the 2 arms: Bariticinib arm VS Placebo arm

Arm	Type	Receives
Bariticinib	Experimental	Drug: Bariticinib 2 mgParticipants will take one capsule containing 2 mg of baricitinib, once daily, oral administration for 12 weeks
Placebo	Placebo comparator	Other: PlaceboParticipants will take one capsule containing inert substance (maltodextrine), once daily, oral administration for 12 weeks.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (29 listed)

If female of childbearing potential, pregnant or planning a pregnancy during the entire study or lactating.
Prior history or clinical manifestations of any physical or psychiatric disorder that could impair the subject's ability to complete the study.
Any active AIDS-defining disease or progression of HIV-related disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy.
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal, or penile intraepithelial neoplasia.
Systemic treatment for cancer within 1 year of study entry.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bariticinib 2 mgCommercially available tablets containing 2 mg of barticiinib will be used. The tablets will be re-capsulated to keep the study blind.	Drug	Bariticinib
PlaceboMaltodextrin capsules with identical weight and appearance (shape, size, colour and flavour) as the bariticinib-containing capsules.	Other	Placebo

Primary outcome

To evaluate the safety and tolerability of baricitinib.
Time frame: From baseline (week 0) to week 12
Proportion of participants developing Grade 3 or 4 treatment-related adverse events or laboratory abnormalities during the study, based on the Division of AIDS (DAIDS) Table for grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 [July 2017].
To evaluate changes in levels of phosphorylated STAT (pSTAT) in CD4+ T cells, as a pharmacodynamic biomarker of baricitinib activity.
Time frame: From baseline (week 0) to week 12
Levels of pSTAT 1, 3 and 5 in CD4+ T cells measured by Flow cytometry.

6 secondary outcomes

To evaluate the effect of baricitinib on proapoptotic pathways mediated by BCL-2.
Time frame: From baseline (week 0) to week 12
To evaluate the effect of baricitinib on JAK/STAT signaling pathway
Time frame: From baseline (week 0) to week 12
To evaluate the effect of baricitinib on the HIV-1 reservoir.
Time frame: From baseline (week 0) to week 12
To evaluate the impact of baricitinib on homeostatic cytokines, inflammatory biomarkers and cell death markers.
Time frame: From baseline (week 0) to week 12
To evaluate the effects of baricitinib in immune cell subsets.
Time frame: From baseline (week 0) to week 12
To characterize baricitinib pharmacokinetics in plasma.
Time frame: From week 4 to week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared publicly due to the exploratory nature of the trial, the limited sample size, and the sensitive nature of the data related to HIV status and immunological profiling.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bariticinib 2 mg in people with HIV, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of baricitinib. (time frame: From baseline (week 0) to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07028385.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.