HIV InfectionPhase 2NCT07209267
Baricitinib Curative Repression of HIV-1
A Phase 2 study testing Antiretroviral Therapy (ART), Baricitinib (LY3009104) 2 mg and Baricitinib (LY3009104) 4 mg in people with HIV Infection and HIV, run by Emory University at 2 sites in United States.
Trial summary
This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, HIV
- What is being tested?
- Antiretroviral Therapy (ART), Baricitinib (LY3009104) 2 mg and Baricitinib (LY3009104) 4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Documented HIV infection
- On continuous ART for at least 96 weeks before enrollment, with no interruption of ART for 7 consecutive days or longer in the 48 weeks before enrollment.
- Plasma HIV-1 RNA levels of <50 copies/mL for at least 96 weeks (a minimum of two measures), and <50 copies/mL for a sample obtained within 90 days before enrollment.
- CD4+ T-cell count ≥500 cells/mm3 obtained within 90 days prior to enrollment
- No known history of CD4+ T-cell count nadir <200 cells/mm3
- Negative pregnancy test at time of study enrollment
- Additional laboratory criteria apply.
Who cannot join
- < 18 years of age or > 70 years of age
- Pregnancy or breastfeeding, as determined by a blood pregnancy test
- History of AIDS-defining illness, except for recurrent pneumonia.
- History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease.
- Untreated latent tuberculosis infection (which will be screened for before entry). If there is a prior positive test, the test does not need to be repeated at screening.
- History of use of any immunomodulatory medications within 6 months before enrollment, including systemic corticosteroids (>14 days), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immunomodulatory effect.
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- History of deep venous thrombosis
- Cardiovascular disease (Coronary artery disease or history of myocardial infarction, Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines, history of stroke)
- History of HIV-associated malignancy, including Kaposi's sarcoma, or any lymphoma/leukemia or virus-associated cancers. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months
- Major surgery within 8 weeks before screening, or will require major surgery during the study
- Current or recent (<4 weeks before screening) clinically serious viral (including COVID-19), bacterial, fungal, or parasitic infection or any other active or recent infection. History of untreated syphilis infection. If a rapid plasma reagin (RPR) test was negative in the 3 months before screening, then an RPR is not needed at screening
- Symptomatic herpes simplex at the time of screening.
- Symptomatic herpes zoster infection within 12 weeks before screening.
- History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or central nervous system (CNS) involvement).
- Positive test for hepatitis B virus (HBV)
- Additional exclusion criteria apply
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Grady Infectious Diseases Clinic (Ponce Center)
Atlanta, Georgia, 30308
Dr. Gavegnano's Laboratory
Atlanta, Georgia, 30322
About this study
This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Researchers will test the effects of continuing baricitinib in people with HIV before and after discontinuing their antiretroviral therapy. This drug is approved by the Food and Drug Administration (FDA) for other diseases; it is not approved for the treatment of HIV-1. The study team will also investigate any side effects associated with the drug.
Read the detailed description
This study will test whether the medication baricitinib, which reduces inflammation and is already approved for other diseases, can delay the return of HIV after stopping antiretroviral therapy (ART). The goal is to see if baricitinib can safely reduce inflammation and the HIV that is hidden in the body. The study will include adults with HIV who have a suppressed viral load on ART.
Participants will receive ART combined with baricitinib for 25 weeks, followed by baricitinib alone after stopping ART. If the virus returns, the previous ART will be restarted. Each participant will be involved in the study for approximately 12 to 18 months.
Blood and other biological samples may be stored for future research use, with the participant's consent.
- Conditions
- HIV Infection, HIV
- Being tested
- Antiretroviral Therapy (ART), Baricitinib (LY3009104) 2 mg, Baricitinib (LY3009104) 4 mg
- Keywords
- Baricitinib, Antiretroviral Therapy (ART)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiretroviral Therapy (ART)Drug
Also called Standard of Care
Antiretroviral Therapy (ART): A treatment regimen for HIV infection that uses a combination of antiretroviral drugs to suppress viral replication, reduce HIV-related morbidity, and prevent transmission.
In Step 1, participants will continue their current ART regimen for 25 weeks.
In Step 2, participants will interrupt ART.
In Step 3, participants will restart ART early if they meet the ART restart criteria before the end of Step 2 (a 25-week maximum). Otherwise, they will resume ART at the end of Step 2.
Baricitinib (LY3009104) 2 mgDrug
Also called Olumiant
Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients.
During Step 1, Baricitinib will be taken at a dose of 2 mg orally daily for 25 weeks.
During Step 2, Baricitinib alone will be continued at a dose of 2 mg orally daily for up to an additional 25 weeks
Baricitinib (LY3009104) 4 mgDrug
Also called Olumiant
Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients.
During Step 1, Baricitinib will be taken at a dose of 4 mg orally daily for 25 weeks.
During Step 2, Baricitinib alone will be continued at a dose of 4 mg orally daily for up to an additional 25 weeks
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib 2mg | Experimental | Adults with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 2 mg per day orally plus their current ART regimen (Step 1).
Following 25 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 25 weeks (Step 2).
If a participant qualifies for ART restart criteria before the end of the maximum 25 weeks of Step 2, they will move to Step 3 early and resume ART, while baricitinib will be discontinued for 25 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 25 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 25 weeks of observation (Step 3). Receives: Drug: Antiretroviral Therapy (ART); Drug: Baricitinib (LY3009104) 2 mg |
| Baricitinib 4mg | Experimental | Adults with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 4 mg per day orally plus their current ART regimen (Step 1).
Following 25 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 25 weeks (Step 2).
If a participant meets the ART restart criteria before the end of the maximum 25 weeks of Step 2, they will advance to Step 3 early and resume ART, while baricitinib will be discontinued for 25 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 25 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 25 weeks of observation (Step 3). Receives: Drug: Antiretroviral Therapy (ART); Drug: Baricitinib (LY3009104) 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to restart ART
Time to restart ART will be defined by a plasma HIV-1 RNA viral load greater than or equal to 1000 copies/mL following withdrawal of ART during 25 weeks of baricitinib treatment alone (following 25 weeks of baricitinib plus ART).
Measured: Up to 25 weeks after the baricitinib treatment alone was started
Number of Participants who discontinued treatment due to adverse events
Participants who permanently discontinued study drug due to treatment-related adverse events.
Measured: Up to 25 weeks after the start of baricitinib alone was started
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events.
Measured: Up to 25 weeks after the start of baricitinib alone was started
Secondary outcomes (1)
Time to a detectable plasma HIV-1 RNA viral load
Time to a detectable plasma HIV-1 RNA viral load (defined as greater than the lower limit of quantification) after analytic treatment Interruption (ATI).
Measured: Up to 25 weeks after baricitinib alone was started.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study startOct 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Step 1: Participants with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 2 plus their current ART regimen. Step 2: Following 25 weeks of baricitinib plus ART, participants will be treated with baricitinib alone (ART will be interrupted) for up to 25 weeks. Step 3: Participants should return as soon as possible after an ART restart criterion has been met or at the end of Step 2. Participants will be followed for 25 weeks during this step.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Vincent Marconi, Emory University
- Investigators
- Vincent Marconi, MD, Principal investigator, Emory UniversityWilliam Tyor, MD, Principal investigator, Emory UniversityChristina Gavegnano, PhD, Principal investigator, Emory UniversityAndrew H Miller, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209267
- Sponsor's protocol ID
- STUDY00009759
- Other IDs
- 2025P012728
- Status last verified
- Aug 2026
- First submitted
- 2 Oct 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share the data that underline the results reported in articles, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baricitinib Curative Repression of HIV-1
- ClinicalTrials.gov ID
- NCT07209267
- Acronym / sponsor ID
- STUDY00009759
- Conditions
- HIV Infection, HIV
- Keywords
- Baricitinib, Antiretroviral Therapy (ART)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Oct 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.
This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Researchers will test the effects of continuing baricitinib in people with HIV before and after discontinuing their antiretroviral therapy. This drug is approved by the Food and Drug Administration (FDA) for other diseases; it is not approved for the treatment of HIV-1. The study team will also investigate any side effects associated with the drug.
Detailed description
This study will test whether the medication baricitinib, which reduces inflammation and is already approved for other diseases, can delay the return of HIV after stopping antiretroviral therapy (ART). The goal is to see if baricitinib can safely reduce inflammation and the HIV that is hidden in the body. The study will include adults with HIV who have a suppressed viral load on ART.
Participants will receive ART combined with baricitinib for 25 weeks, followed by baricitinib alone after stopping ART. If the virus returns, the previous ART will be restarted. Each participant will be involved in the study for approximately 12 to 18 months.
Blood and other biological samples may be stored for future research use, with the participant's consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Step 1: Participants with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 2 plus their current ART regimen. Step 2: Following 25 weeks of baricitinib plus ART, participants will be treated with baricitinib alone (ART will be interrupted) for up to 25 weeks. Step 3: Participants should return as soon as possible after an ART restart criterion has been met or at the end of Step 2. Participants will be followed for 25 weeks during this step.
| Arm | Type | Receives |
|---|---|---|
| Baricitinib 2mg | Experimental | Drug: Antiretroviral Therapy (ART), Drug: Baricitinib (LY3009104) 2 mgAdults with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 2 mg per day orally plus their current ART regimen (Step 1). Following 25 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 25 weeks (Step 2). If a participant qualifies for ART restart criteria before the end of the maximum 25 weeks of Step 2, they will move to Step 3 early and resume ART, while baricitinib will be discontinued for 25 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 25 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 25 weeks of observation (Step 3). |
| Baricitinib 4mg | Experimental | Drug: Antiretroviral Therapy (ART), Drug: Baricitinib (LY3009104) 4 mgAdults with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 4 mg per day orally plus their current ART regimen (Step 1). Following 25 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 25 weeks (Step 2). If a participant meets the ART restart criteria before the end of the maximum 25 weeks of Step 2, they will advance to Step 3 early and resume ART, while baricitinib will be discontinued for 25 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 25 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 25 weeks of observation (Step 3). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented HIV infection
- On continuous ART for at least 96 weeks before enrollment, with no interruption of ART for 7 consecutive days or longer in the 48 weeks before enrollment.
- Plasma HIV-1 RNA levels of <50 copies/mL for at least 96 weeks (a minimum of two measures), and <50 copies/mL for a sample obtained within 90 days before enrollment.
- CD4+ T-cell count ≥500 cells/mm3 obtained within 90 days prior to enrollment
- No known history of CD4+ T-cell count nadir <200 cells/mm3
Key exclusion criteria (16 listed)
- < 18 years of age or > 70 years of age
- Pregnancy or breastfeeding, as determined by a blood pregnancy test
- History of AIDS-defining illness, except for recurrent pneumonia.
- History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease.
- Untreated latent tuberculosis infection (which will be screened for before entry). If there is a prior positive test, the test does not need to be repeated at screening.
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 |
|---|---|---|
| Antiretroviral Therapy (ART)Also: Standard of CareAntiretroviral Therapy (ART): A treatment regimen for HIV infection that uses a combination of antiretroviral drugs to suppress viral replication, reduce HIV-related morbidity, and prevent transmission. In Step 1, participants will continue their current ART regimen for 25 weeks. In Step 2, participants will interrupt ART. In Step 3, participants will restart ART early if they meet the ART restart criteria before the end of Step 2 (a 25-week maximum). Otherwise, they will resume ART at the end of Step 2. | Drug | Baricitinib 2mg, Baricitinib 4mg |
| Baricitinib (LY3009104) 2 mgAlso: OlumiantBaricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. During Step 1, Baricitinib will be taken at a dose of 2 mg orally daily for 25 weeks. During Step 2, Baricitinib alone will be continued at a dose of 2 mg orally daily for up to an additional 25 weeks | Drug | Baricitinib 2mg |
| Baricitinib (LY3009104) 4 mgAlso: OlumiantBaricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. During Step 1, Baricitinib will be taken at a dose of 4 mg orally daily for 25 weeks. During Step 2, Baricitinib alone will be continued at a dose of 4 mg orally daily for up to an additional 25 weeks | Drug | Baricitinib 4mg |
Primary outcome
Time to restart ART
Time frame: Up to 25 weeks after the baricitinib treatment alone was started
Time to restart ART will be defined by a plasma HIV-1 RNA viral load greater than or equal to 1000 copies/mL following withdrawal of ART during 25 weeks of baricitinib treatment alone (following 25 weeks of baricitinib plus ART).
Number of Participants who discontinued treatment due to adverse events
Time frame: Up to 25 weeks after the start of baricitinib alone was started
Participants who permanently discontinued study drug due to treatment-related adverse events.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 25 weeks after the start of baricitinib alone was started
Number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events.
1 secondary outcome
Time to a detectable plasma HIV-1 RNA viral load
Time frame: Up to 25 weeks after baricitinib alone was started.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. The research team will share the data that underline the results reported in articles, after deidentification
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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.
Vincent Marconi, MD principal investigator
Emory University
William Tyor, MD principal investigator
Emory University
Christina Gavegnano, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antiretroviral Therapy (ART), Baricitinib (LY3009104) 2 mg and Baricitinib (LY3009104) 4 mg in people with HIV Infection and HIV, run by Emory University at 2 sites in United States.
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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Marconi, MD (404-616-0673, vcmarco@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to restart ART (time frame: Up to 25 weeks after the baricitinib treatment alone was started). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.