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Cancer drug dasatinib takes aim at hidden HIV in small trial

NCT ID NCT07342491

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 05, 2026 · Updated 5 times

Summary

This study tests whether dasatinib, a drug used for leukemia, can reduce the hidden HIV reservoir in people whose virus is already suppressed by antiretroviral therapy (ART). Fourteen adults on ART for at least 4 years will be randomly assigned to take dasatinib or a placebo daily for 12 weeks, with 24 weeks of follow-up. The goal is to see if the drug safely lowers the amount of dormant HIV in the body.

What this could mean

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

Active substance
Dasatinib (a cancer drug taken as a pill)
What this could lead to
If it works, this could point toward a way to shrink the hidden HIV reservoir, potentially helping people manage HIV without needing lifelong medication.
What could go wrong
This is a very early, small Phase 1 trial with only 14 people. Dasatinib may not reduce the reservoir at all, and it can cause side effects like low blood counts or fluid retention.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: * HIV-1 infection * Active antiretroviral therapy received continuously for 48 months (or longer) * CD4+ cell count \>450 cells/mm3 obtained within 12 months prior to study entry * Plasma HIV-1 RNA level below the lower limit of quantification within 90 days prior to study entry * Plasma HIV-1 RNA levels below the lower limit of quantification for \>36 months at time of study entry * The following laboratory values obtained within 90 days prior to entry: * Absolute neutrophil count (ANC) above the lower limit of normal * Hemoglobin above the lower limit of normal * Platelet count above the lower limit of normal * Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase \<1.5 x ULN * Total bilirubin \<1.5 x ULN * Negative hepatitis B virus (HBV) surface antigen (HBsAg) * Negative HBV core antibody with one exception: individuals with positive HBV core antibody and HBV surface antibody are eligible for enrollment * Negative hepatitis C virus (HCV) antibody (anti-HCV) or, if the anti-HCV is positive, a negative HCV RNA PCR * Estimated glomerular filtration rate (eGFR) \>70 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) 2021 equation or serum creatinine \<1.2 x ULN * QTc interval \<450 milliseconds on EKG performed at screening visit * Women who are able to become pregnant must have a negative serum or urine pregnancy test at screening and within 48 hours prior to study entry * Individuals (male or female) who are having sex that could lead to pregnancy, must agree to use at least two effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through 60 days following the last dose of dasatinib * Able to swallow pills without difficulty. * Ability and willingness of participant or legally authorized representative to provide informed consent * Ability and willingness of participant to continue same ART regimen throughout the study Exclusion Criteria: * Pre-ART viral load known to be \<2000 copies/mL (HIV controller) * Known to have initiated ART during acute HIV infection * Presence of a drug-resistant virus with no alternative ART regimens available in the event that current ART regimen becomes compromised as a result of this study * Current pregnancy or breastfeeding or pregnancy planning during study participation * Recent hospitalization or surgery within 90 days prior to entry * Recent infection requiring intravenous antibiotics within 90 days prior to entry * Any evidence of hepatic impairment * Any known prior (lasting \>180 days) or current history of gastrointestinal-related diseases * Active malignancy including myelodysplastic syndrome or myeloproliferative disease. * Any known prior (lasting \>180 days) or current history of hematologic illness * Any known prior (lasting \>180 days) or current history of cardiac-related diseases * Untreated hypothyroidism * Treatment for TB within the past 90 days. * Current respiratory disease requiring supplemental oxygen * Exposure to any systemic immunomodulatory drug (including maraviroc) in the 16 weeks prior to study entry * Exposure to anticoagulant or anti-platelet medications in the 16 weeks prior to study entry * Active use of medications known to prolong the QT interval * Known family history of Long QT Syndrome in a first-degree relative (i.e., parent, offspring, or sibling) * Active use of medications known to moderately or strongly induce or inhibit CYP3A4, including ART regimens that contain protease inhibitors, efavirenz, etravirine, or cobicistat at the time of screening or study entry * Current substance use which is likely to interfere with the conduct of the study * Anticipated conflict or inability to attend and complete all protocol-scheduled study visits and assessments * Known allergy/sensitivity or any hypersensitivity to components of dasatinib or its formulation * Active use of azithromycin, Ondansetron, Pentamidine at study entry

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 1401, University of Washington Positive Research CRS

    RECRUITING

    Seattle, Washington, 98104, United States

  • 2501, Case CRS

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Northwestern University CRS (Site # 2701)

    RECRUITING

    Chicago, Illinois, 60611, United States

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