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Study on the Safety and Effects of Dasatinib in Patients with Recent HIV-1 Infection

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What is this trial about?

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

This clinical trial is focused on studying the safety and tolerance of a medication called dasatinib in patients who have recently been infected with HIV-1 but do not show any symptoms. Dasatinib is a type of medication known as a protein kinase inhibitor, which means it works by blocking certain proteins that help the virus grow. The study will compare the effects of dasatinib with a placebo, which is a substance that looks like the medication but does not contain any active ingredients.

The purpose of the study is to evaluate how safe and tolerable dasatinib is for people with recent HIV-1 infection. Participants will take the medication for a period of time, and researchers will monitor them to see how their bodies respond. The study will also look at how the medication affects the immune system and the levels of the virus in the body. This includes checking the number of certain immune cells and markers of inflammation, as well as measuring the amount of virus present before starting any other antiretroviral therapy.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how dasatinib impacts the virus and the immune system. The study aims to provide valuable insights into whether dasatinib can be a safe and effective treatment option for people with recent HIV-1 infection. The trial is expected to continue until 2026, allowing researchers to collect comprehensive data over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will provide written informed consent, confirming understanding and agreement to participate.

    Eligibility is confirmed based on age (18 to 65 years), documented asymptomatic HIV-1 infection for more than 3 months, and a CD4 T lymphocyte count greater than 350 per microliter.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the patient's health status and confirm eligibility criteria.

    This includes a review of medical history and a physical examination.

  3. Step 3

    Medication administration

    The patient will begin taking the medication dasatinib orally. The specific dosage and frequency will be provided by the study team.

    The duration of this phase is 4 weeks, during which the patient will take dasatinib as a monotherapy, meaning it is the only medication being taken for the study.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the safety and tolerability of dasatinib. This includes checking for any side effects or adverse reactions.

    The study team will conduct various tests to evaluate immune recovery, inflammatory markers, and other health indicators.

  5. Step 5

    Completion of study

    Upon completion of the study period, a final assessment will be conducted to evaluate the overall health and response to the medication.

    The patient will receive information about the study's findings and any further steps if necessary.

Who can join the trial?

5 criteria

  • Age range: 18 to 65 years.
  • Documented asymptomatic HIV-1 infection of more than 3 months duration. This means you have tested positive for HIV-1 but do not show symptoms, and the infection has been present for more than 90 days.
  • Not having received ART (antiretroviral therapy), which is the treatment for HIV.
  • CD4 T lymphocyte count greater than 350 cells per microliter. CD4 T lymphocytes are a type of white blood cell important for your immune system.
  • Patient giving written informed consent, meaning you agree to participate in the study after being fully informed about it.

Who cannot join the trial?

10 criteria

  • Patients who have symptoms of HIV-1 infection cannot participate.
  • Patients who have been infected with HIV-1 for less than 3 months cannot participate.
  • Patients who are currently taking other medications that might interfere with the study drug cannot participate.
  • Patients with a history of severe allergic reactions to similar medications cannot participate.
  • Patients with significant heart problems cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections other than HIV-1 cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients with a history of cancer within the last 5 years cannot participate.
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Investigated drugs

Dasatinib is a medication being tested in this clinical trial. It is known as a type of ITK, which stands for immunomodulatory tyrosine kinase inhibitor. This medication is being studied to see if it is safe and well-tolerated by people who have recently been infected with HIV-1 but do not yet show symptoms. The goal is to understand how dasatinib might help in managing the virus in these patients. By participating in this trial, researchers hope to learn more about how dasatinib can be used as part of a new treatment strategy for HIV-1 infection.

What is already known about the treatment

Dasatinib – Dasatinib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its safety and effectiveness in treating asymptomatic patients with recent HIV-1 infection. The main therapeutic indication for dasatinib in this context is to manage HIV-1 infection in patients who have recently contracted the virus but do not yet show symptoms. At the molecular level, dasatinib works by inhibiting certain proteins that are involved in the replication of the virus, thereby slowing down the progression of the infection. It is classified pharmacologically as a tyrosine kinase inhibitor (TKI), which is a type of medication that blocks specific enzymes involved in the growth and spread of cancer cells and viruses.

Investigated diseases

Human Immunodeficiency Virus Type 1 (HIV-1) Infection – HIV-1 infection is a viral disease caused by the human immunodeficiency virus type 1, which primarily attacks the immune system. In the early stages, individuals may not show symptoms, which is referred to as the asymptomatic phase. During this phase, the virus replicates in the body and gradually weakens the immune system by targeting CD4 cells, a type of white blood cell. As the infection progresses, the immune system becomes increasingly compromised, making the body more susceptible to other infections and diseases. Over time, if untreated, the infection can lead to acquired immunodeficiency syndrome (AIDS), where the immune system is severely damaged.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519641-30-00Protocol codeDASAHIVCUREEstimated enrolment24 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

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