Dasatinib for HIV-1 Reservoir Reduction Study

This study is testing if a medicine called dasatinib can reduce the hidden amount of HIV in the body, known as the HIV "reservoir." It also aims to see if dasatinib is safe and well-tolerated for people living with HIV who are already on antiretroviral therapy (ART) and have a suppressed viral load. You might be able to join if you are 18 or older, have HIV-1 infection, have been on ART for at least 48 months, and have had a suppressed HIV-1 viral load for at least 36 months. The study will measure changes in the HIV reservoir size and track any side effects to see if dasatinib is effective and safe.

Study design: This is an interventional study with 14 planned participants. You will be randomly assigned to receive either dasatinib or a placebo (an inactive substance) for 12 weeks, and neither you nor the researchers will know which you are receiving (double-blind).
What's involved: You will take one capsule of either dasatinib or placebo by mouth once daily for 12 weeks.
Compensation: Not stated in the trial record.
Follow-up: Your health will be monitored for treatment-related adverse events (side effects) from the first dose through week 36.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Dasatinib for HIV-1 Reservoir Reduction

Recruiting

PHASE1Ages 18+InterventionalTreatment

National Institute of Allergy and Infectious Diseases (NIAID)

~14 participants

Updated 2026-08-04 on ClinicalTrials.gov

What's tested:DasatinibPlacebo

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in intact HIV-1 reservoir size

Measured over Baseline and week 12

+1 more outcome measured

Conditions

HIV Infections

Where it's being run

3 sites across 3 states

Illinois1

Ohio1

Washington1

Who to contact

Sherryl Wolfe, BSN, RN, CRCC

[email protected]

312-695-4997

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Change in intact HIV-1 reservoir sizeBaseline and week 12
Change in the intact HIV-1 reservoir from baseline to week 12, measured by the Intact Proviral DNA Assay (IPDA), or the best available assay at the time of testing if IPDA is not available.
Number of Study treatment-related adverse eventsFrom first dose through week 36
Occurrence of any study treatment-related serious adverse event (SAE), any Grade 2 or higher adverse event (AE), or any AE that leads to permanent discontinuation of study treatment, regardless of grade.

Trialytics