Cancer drug dasatinib takes aim at hidden HIV in small trial
NCT ID NCT07342491
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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1401, University of Washington Positive Research CRS
RECRUITINGSeattle, Washington, 98104, United States
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2501, Case CRS
RECRUITINGCleveland, Ohio, 44106, United States
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Northwestern University CRS (Site # 2701)
RECRUITINGChicago, Illinois, 60611, United States
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