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Safety and Efficacy of Dasatinib in Reducing HIV-1 Reservoir, Inflammation, and Immune Senescence in People with HIV on Long‑Term Antiretroviral Therapy

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What is this trial about?

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

The study focuses on people living with HIV-1 infection who are already taking long‑term antiretroviral medication. Even with treatment, the virus can hide in cells, cause ongoing low‑grade chronic inflammation, and lead to a gradual weakening of the immune system known as immune senescence. The trial will compare an oral tablet containing the drug dasatinib (50 mg) with an inactive substance called placebo to see if the active drug can safely reduce the hidden virus, lower inflammation, and improve immune function.

The purpose of the study is to determine whether adding dasatinib can change the number and activity of important immune cells, specifically the white‑blood‑cell types called CD4, CD8 and CD56+. Participants will take either dasatinib or placebo for about a year, with regular clinic visits where blood samples are taken at several intervals (early after starting, then roughly every few months) to measure these cells, inflammation signals, and any side effects. Terms such as “viral reservoir” refer to the hidden virus that remains in cells despite treatment, and “inflammation markers” are blood signals that show how much inflammation is present.

Throughout the trial, doctors will closely watch for any adverse events, meaning any unwanted medical problems, and will perform routine laboratory tests to ensure safety. The study will track how the immune cells and inflammation markers change over time, providing information on whether dasatinib can offer additional benefit to people already on antiretroviral therapy.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of treatment

    After joining the study you will be assigned to receive either dasatinib tablets or a placebo (microcrystalline cellulose). the assignment is done randomly and you will not know which you receive.

    You will begin taking one tablet by mouth each day. each dasatinib tablet contains 50 mg of the active ingredient. the placebo tablets contain no active drug.

    The medication schedule will continue for 48 weeks unless a doctor decides to stop it earlier.

  2. Step 2

    Early follow‑up (day 2‑3)

    Within two to three days after the first dose you will return to the clinic for a brief visit.

    Blood will be drawn to check early changes in immune cells such as cd4, cd8 and cd56+ cells and to monitor safety.

  3. Step 3

    Week 4 visit

    You will attend a clinic visit at the end of week 4.

    Blood samples will be taken to measure immune cell counts, activation markers, inflammation markers and any side effects.

    The study team will review your medication use and any symptoms you have experienced.

  4. Step 4

    Week 12 visit

    At week 12 you will have another clinic appointment.

    Blood will be collected to assess the same laboratory parameters as before, allowing comparison over time.

    Any adverse events (side effects) will be recorded.

  5. Step 5

    Week 24 visit

    The week 24 visit marks the halfway point of the 48‑week treatment period.

    Comprehensive blood testing will be performed to evaluate changes in immune cells, inflammation markers and viral reservoir characteristics.

    The study staff will check that you are still taking the medication as directed.

  6. Step 6

    Week 28 visit

    A clinic visit at week 28 will include blood draws for the same set of measurements as previous visits.

    The focus will be on tracking trends in immune exhaustion, senescence and the size of the hiv‑1 reservoir.

  7. Step 7

    Week 36 visit

    At week 36 you will again provide blood samples for laboratory analysis.

    The data will be used to monitor ongoing changes in immune function and safety.

  8. Step 8

    Week 48 visit (end of treatment)

    The final scheduled visit occurs at week 48, completing the 48‑week medication period.

    A full set of blood tests will be performed to evaluate the overall effect of the treatment on immune cells, inflammation, and the hiv‑1 reservoir.

    The study team will discuss the results with you and record any final adverse events.

Who can join the trial?

7 criteria

  • The participant must be at least 18 years old, understand the study information, and sign the written informed consent before any screening.
  • The participant must have a confirmed diagnosis of HIV-1 infection (the virus that weakens the immune system).
  • The participant must have been on a stable, suppressive ART (antiretroviral therapy, medicines that keep the virus at very low levels) for 1 to 10 years, with virus levels undetectable for at least the last 6 months; occasional tiny increases (<200 copies per milliliter) are allowed if they are rare.
  • The participant must show a CD4 count greater than 500 cells per mm³ (a measure of immune cells) and/or a CD4/CD8 ratio close to 1.0 ± 0.2 (a balance between two types of immune cells).
  • The participant’s ART regimen must have been unchanged for at least six months before screening and must remain unchanged during the screening period.
  • The participant must agree to take their ART consistently and follow the study’s treatment plan for the full 24‑week period.
  • If the participant or their partner could become pregnant, they must use a highly effective method of contraception throughout the study; this includes men who are sexually active and women who are not postmenopausal (no period for at least 12 months).

Who cannot join the trial?

18 criteria

  • Unable or unwilling to follow all study visits, take the medication as prescribed, complete laboratory tests, follow lifestyle instructions, or perform any other required study procedures.
  • Pregnant or breastfeeding women (pregnancy is the condition after conception until the baby is born).
  • Any other health condition that the doctor believes could affect the safety of the study or the accuracy of the results.
  • Any situation that would make it difficult to follow the study plan.
  • Currently taking part in another clinical trial, or having taken part in one within the past three months.
  • Having a serious ongoing illness such as an active infection, symptoms of heart failure, fluid buildup around the lungs (pleural effusion) or heart (pericardial effusion), lung swelling (pulmonary edema), unstable chest pain (unstable angina), irregular heart rhythm, uncontrolled high blood pressure, a prolonged QT interval (a heart electrical measurement that is >450 ms for men or >470 ms for women), using medicines that lengthen the QT interval, or mental health or social problems that would prevent study participation.
  • History of serious heart rhythm problems such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes.
  • History of significant fluid buildup around the lungs (pleural effusion).
  • History of serious bleeding disorders, including inherited bleeding conditions, bleeding problems that occurred in the first year of life, or recent (within three months) major gastrointestinal bleeding.
  • Abnormal blood test results at screening, including:
    • Hemoglobin less than 11 g/dL (low red blood cell level).
    • Platelet count less than 75,000 per microliter (low clotting cells).
    • Absolute neutrophil count less than 1,000 cells/µL (low white blood cells that fight infection).
    • ALT or AST (liver enzymes) more than 1.5 times the normal upper limit.
    • Low potassium (hypokalemia) according to local lab standards.
    • Low magnesium (hypomagnesemia) according to local lab standards.
    • Positive test for hepatitis B surface antigen or hepatitis C antibody without having received treatment or cleared the infection.
    • Lactose intolerance or malabsorption conditions such as hereditary galactose intolerance, total lactase deficiency, or glucose‑galactose malabsorption.
    • Current use of medicines that interfere with dasatinib metabolism, specifically drugs that are broken down by the enzyme CYP3A4 or that increase the activity of CYP3A4.
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Investigated drugs

Dasatinib is an oral tablet that is being tested in this study to see if it can help people living with HIV. Researchers want to find out whether taking dasatinib can lower the amount of hidden HIV in the body, reduce ongoing inflammation, and improve the health of the immune system. The medication will be given to participants who are already on long‑term antiretroviral therapy, and its effects on immune cells and markers of immune aging will be closely monitored.

What is already known about the treatment

  • Microcrystalline cellulose

    This substance is taken orally as a tablet filler that is swallowed whole, serving only as a placebo. It is an inert powder with no therapeutic effect and is used solely to mimic a real drug in clinical studies. Because it is not an active medication, it has no approved medical use and is not discussed as a treatment in the literature. It belongs to the class of pharmaceutical excipients that help form tablets.

  • Dasatinib

    Dasatinib is administered as a 50 mg film‑coated tablet taken by mouth (oral route). It is an approved drug for certain blood cancers and is currently being studied to reduce the HIV‑1 reservoir, chronic inflammation, and immune aging in people on long‑term antiretroviral therapy. The medication works by blocking specific enzymes called tyrosine kinases, which stops cell‑signaling pathways that drive abnormal cell growth and activation. It is classified as a tyrosine‑kinase inhibitor.

Investigated diseases

HIV-1 infection - HIV-1 infection is a viral disease caused by the human immunodeficiency virus type 1. The virus enters the body and targets cells that help fight infections. Over time it reduces the number of these helper cells, weakening the immune system. As the infection continues, the body becomes less able to control other germs. The disease can spread from person to person through blood, sexual contact, or from mother to child. The amount of virus in the blood can change, influencing how quickly the immune cells are lost.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524363-20-01Protocol codeDASAVIREstimated enrolment60 patients

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