Cancer drug dasatinib tested to shrink hidden HIV reservoirs

NCT ID NCT05780073

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether a low dose of dasatinib, a cancer drug, is safe and can reduce the hidden HIV reservoir and inflammation in people with HIV who are already on effective antiretroviral therapy. Sixty participants took either dasatinib or a placebo daily for 24 weeks while continuing their regular HIV medications. The study measured safety, immune activation, and changes in the HIV reservoir.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dasatinib
What this could lead to
If it works, this could point toward a way to shrink the hidden HIV reservoir and reduce chronic inflammation in people already on antiretroviral therapy.
What could go wrong
This is a small, early-phase trial focused on safety and biological markers, not a cure. Dasatinib is a cancer drug with known side effects, and it may not meaningfully reduce the viral reservoir or improve health outcomes.

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

60 people

The number who actually took part.

Started

Oct 2023

Finished

Apr 2025

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 years and older

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Males and females aged at least 18 years on the day of screening. * 2\. Confirmed HIV-1 infection. * 3\. Receiving suppressive cART for at least 3 years (defined as maintained plasma viral load \<50 copies/mL, allowing for isolated blips \[\<200 cop/ml, non-consecutive, representing \<20% total determinations\]). * 4\. Being on the same ART regimen within at least 4 weeks prior to baseline visit. * 5\. Willing and able to be adherent to their ART regimen for the duration of the study. * 6\. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. * 7\. In the opinion of the Principal Investigator, the candidate has understood the information provided and can give written Informed Consent. * 8\. If heterosexually active female of childbearing potential, using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner) from 14 days prior to the first Investigational Medicinal Product (IMP) administration and commit to use it until 3 months after the last IMP administration. All female candidates of childbearing potential who are not heterosexually active at screening, must agree to utilize an effective method of contraception if they become heterosexually active during the study. * 9\. If heterosexually active male, regardless of reproductive potential, sterilized or agree on the use of an effective method of contraception by his female partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day of the first IMP administration until 3 months after the last IMP administration. All male candidates who are not heterosexually active at screening, must agree to utilize an effective method of contraception if they become heterosexually active during the study. * 10\. If female, willing to undergo urine pregnancy tests at the designated time points. * 11\. Willing to accept blood draws at time points specified in the Schedule of Events Exclusion Criteria: * 1\. If female, pregnant or planning a pregnancy during the entire study or lactating. * 2\. Current treatment with ART regimen that includes ritonavir, cobicistat or with any other drug with known relevant drug-drug interactions with dasatinib. * 3\. Has received any immunotherapy with intent to cure or prevent HIV, including monoclonal antibodies, therapeutic or preventive vaccines within 6 months prior to baseline visit. * 4\. Prior history of exposure to dasatinib or any other Tyrosine Kinase Inhibitor (TKI). * 5\. Prior history of pleural effusion. * 6\. Prior history or clinical manifestations of any physical or psychiatric disorder that could impair the subject's ability to complete the study. * 7\. Any active AIDS-defining disease or progression of HIV-related disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy. * 8\. 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. * 9\. Systemic treatment for cancer within 1 year of study entry. * 10\. Known hypersensitivity to any component of the IMP formulation, or severe or multiple allergies to drugs or pharmaceutical agents. * 11\. Potential participant received or plans to receive: 1. Licensed live attenuated vaccines within 28 days before or after inflammation and immune biomarkers visit (weeks 0, 2, 24 and 48). 2. other vaccines (eg, tetanus, hepatitis A, hepatitis B, rabies, pneumococcal, recombinant Herpes Zoster, Influenza, Coronavirus Disease -19 \[COVID-19\] vaccines) within 14 days before or after inflammation and immune biomarkers visits (weeks 0, 2, 24 and 48). * 12\. Receipt of blood products within 3 months of study entry. * 13\. 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). * 14\. 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. * 15\. Any laboratory abnormalities including: Hematology: * Hemoglobin \<10.0 g/dl, * Absolute neutrophil count ≤3,000 /mm3, * Platelets ≤100,000/mm3, Biochemistry: * Estimated glomerular filtration rate (eGFR) \<60 ml/min, * Aspartate Transferase (AST) \> 2.5 x upper limit of normal (ULN), * Alanine Transaminase (ALT) \> 2.5 x ULN, Microbiology: * Positive for hepatitis B surface antigen, * Positive for hepatitis C antibody, unless confirmed clearance of hepatitis C virus (HCV) infection (spontaneous or following treatment) * Positive serology indicating active syphilis requiring treatment * 16\. Has a corrected QT interval (QTc interval) ≥470 msec (males) or ≥480 msec (females) upon confirmation on recheck at screening, has a history of risk factors for Torsades de Pointes (eg, heart failure/cardiomyopathy or family history of long QT syndrome), or is taking concomitant medications that prolong the QT/QTc interval.

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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

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

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