Dasatinib to Try Lower Hidden HIV in People on ART
Official title: Dasatinib for HIV-1 Reservoir Reduction
Run by National Institute of Allergy and Infectious Diseases (NIAID) · NCT07342491 · Data updated 2026-11-12
We’re testing if the drug dasatinib can help reduce the hidden HIV reservoir in people on effective ART.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 14 (estimated) |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Drugs / interventions | dasatinib |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Status | Recruiting |
| Started | May 8, 2026 |
| Main results expected | April 9, 2027 |
| Study ends | September 24, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07342491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ on ART for at least 48 months with sustained viral suppression for over 36 months and meeting specified blood test criteria.
✕Probably not a fit
People who do not meet the immune or lab criteria or who experience adverse effects may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, double-blind study will compare dasatinib 100 mg taken daily to a placebo for 12 weeks, followed by 24 weeks of monitoring. Participants are adults on continuous ART with long-term viral suppression and adequate immune cell counts. Researchers will monitor safety, tolerability, HIV reservoir size, and immune cell changes through regular visits and blood tests. The trial aims to see if dasatinib is safe and feasible for reducing persistent HIV in this population.
Why it matters
Potential benefit: If successful, dasatinib could offer a new approach to reduce the HIV reservoir in people on ART.
How similar studies have gone: Prior HIV reservoir–targeting strategies have shown mixed results; this approach is exploratory and seeks new evidence on dasatinib’s effect.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 ≤425 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. Permissible ART regimens consist of one or two nucleoside analogs and an integrase inhibitor. 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
Where it's running
-
Northwestern University CRS (Site # 2701)
Chicago, Illinois, United States Recruiting -
2501, Case Clinical Research Site
Cleveland, Ohio, United States Recruiting -
1401, University of Washington Positive Research CRS
Seattle, Washington, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.