Can an arthritis drug help control HIV? new study investigates
NCT ID NCT07028385
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests whether baricitinib, a drug used for arthritis, can safely reduce the hidden HIV reservoirs in people who already have the virus under control with standard HIV medication. Thirty adults with HIV will take either baricitinib or a placebo daily for 12 weeks while staying on their regular HIV drugs. The goal is to see if baricitinib can help the immune system better target and shrink these viral hiding places.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
30 people
The number who actually took part.
- Started
-
Sep 2025
- Finished
-
Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 64 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, 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. Exclusion Criteria: * 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. * Potential participant received or plans to receive: i. Licensed live attenuated vaccines within 28 days before or after inflammation and immune biomarkers visit (weeks 0 and 12). ii. 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,
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HIV are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can 'Queen Mothers' bring HIV testing to the doorstep?
- Scientists map HIV's hiding spots in early infection
- Can local clinics keep more people with HIV in care?
- Can a phone call keep HIV-Positive mothers and babies on track?
- Can a phone app and a health worker ease depression in rural HIV care?
- Can a diabetes and Weight-Loss drug help break cocaine addiction?