HIV InfectionsPhase 1NCT07342491
Dasatinib for HIV-1 Reservoir Reduction
A Phase 1 study testing Dasatinib in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
This study will test if the medicine dasatinib can lower the hidden amount of HIV in the body, called the HIV "reservoir." It will also check if dasatinib is safe and easy to take for people living with HIV who have a suppressed viral load while on antiretroviral therapy (ART). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 May 2026to 24 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Northwestern University CRS (Site # 2701)
Chicago, Illinois, 60611
Sherryl Wolfe, BSN, RN, CRCC, 312-695-4997, s-wolfe@northwestern.edu
- Recruiting
2501, Case Clinical Research Site
Cleveland, Ohio, 44106
Julie Pasternak, 216-844-2738, pasternak.julie@clevelandactu.org
- Recruiting
1401, University of Washington Positive Research CRS
Seattle, Washington, 98104
Christine Jonsson, 206-744-8886, cjonsson@uw.edu
About this study
This study will test if the medicine dasatinib can lower the hidden amount of HIV in the body, called the HIV "reservoir." It will also check if dasatinib is safe and easy to take for people living with HIV who have a suppressed viral load while on antiretroviral therapy (ART). Adults 18 years or older who have been on ART for at least 48 months and have had a suppressed HIV-1 viral load for at least 36 months may be able to join.
People will be randomly assigned to take dasatinib 100 mg by mouth once a day or a look-alike substance with no drug, called a placebo, for 12 weeks. Neither participants nor researchers will know who gets which (double-blind). The study team will do regular health checks and blood tests to track safety, tolerability, the HIV reservoir, and changes in immune cells.
The study lasts 36 weeks total: 12 weeks of treatment and 24 weeks of follow-up, with clinic visits and possible phone calls. Fourteen people will take part; eight will get dasatinib and six will get placebo. Dasatinib may lower the HIV reservoir, but this is not guaranteed. All medicines can cause side effects, called adverse events (AE). The study team will watch closely and provide medical support. Joining is your choice, and you can leave at any time. If you leave, the team will talk with you about next steps for your care.
- Conditions
- HIV Infections
- Being tested
- Dasatinib, Placebo
- Keywords
- Antiretroviral Therapy (ART), Viral Persistence, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
will be administered as one 100 mg capsule (over-encapsulated tablet) orally once daily for 12 weeks
PlaceboOther
Placebo for dasatinib will be administered as one placebo capsule (over-encapsulated tablet) orally once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: dasatinib | Experimental | 100 mg by mouth daily Receives: Drug: Dasatinib |
| Arm 2: Placebo | Placebo comparator | Placebo for dasatinib Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intact HIV-1 reservoir size
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.
Measured: Baseline and week 12
Number of Study treatment-related adverse events
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.
Measured: From first dose through week 36
Secondary outcomes (4)
Anti-proliferative effects after 1 week of dasatinib
Change in immune cell proliferation after 1 week of dasatinib, compared with baseline. Proliferation will be assessed in CD4+ and/or CD8+ T cells using standard markers or assays
Measured: Baseline and week 1
Changes in T cell subset composition and cellular Ki-67 expression
Changes from baseline to week 12 in T cell subset composition and Ki-67 expression.
Measured: Baseline to week 12
Changes in HIV-1 cell-associated RNA transcripts in total CD4+ T cells
Measured in total CD4+ T cells
Measured: Baseline to week 12
Changes in low-level plasma viremia (single-copy assay)
Measured using the single-copy assay
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start8 May 2026
- Primary completion9 Apr 2027 (estimated)
- Study completion24 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342491
- Sponsor's protocol ID
- A5413
- Other IDs
- 39065
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dasatinib for HIV-1 Reservoir Reduction
- ClinicalTrials.gov ID
- NCT07342491
- Acronym / sponsor ID
- A5413
- Conditions
- HIV Infections
- Keywords
- Antiretroviral Therapy (ART), Viral Persistence, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 8 May 2026 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 24 Sep 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test if the medicine dasatinib can lower the hidden amount of HIV in the body, called the HIV "reservoir." It will also check if dasatinib is safe and easy to take for people living with HIV who have a suppressed viral load while on antiretroviral therapy (ART). Adults 18 years or older who have been on ART for at least 48 months and have had a suppressed HIV-1 viral load for at least 36 months may be able to join.
People will be randomly assigned to take dasatinib 100 mg by mouth once a day or a look-alike substance with no drug, called a placebo, for 12 weeks. Neither participants nor researchers will know who gets which (double-blind). The study team will do regular health checks and blood tests to track safety, tolerability, the HIV reservoir, and changes in immune cells.
The study lasts 36 weeks total: 12 weeks of treatment and 24 weeks of follow-up, with clinic visits and possible phone calls. Fourteen people will take part; eight will get dasatinib and six will get placebo. Dasatinib may lower the HIV reservoir, but this is not guaranteed. All medicines can cause side effects, called adverse events (AE). The study team will watch closely and provide medical support. Joining is your choice, and you can leave at any time. If you leave, the team will talk with you about next steps for your care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: dasatinib | Experimental | Drug: Dasatinib100 mg by mouth daily |
| Arm 2: Placebo | Placebo comparator | Other: PlaceboPlacebo for dasatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinibwill be administered as one 100 mg capsule (over-encapsulated tablet) orally once daily for 12 weeks | Drug | Arm 1: dasatinib |
| PlaceboPlacebo for dasatinib will be administered as one placebo capsule (over-encapsulated tablet) orally once daily for 12 weeks | Other | Arm 2: Placebo |
Primary outcome
Change in intact HIV-1 reservoir size
Time frame: Baseline 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 events
Time frame: From 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.
4 secondary outcomes
Anti-proliferative effects after 1 week of dasatinib
Time frame: Baseline and week 1
Changes in T cell subset composition and cellular Ki-67 expression
Time frame: Baseline to week 12
Changes in HIV-1 cell-associated RNA transcripts in total CD4+ T cells
Time frame: Baseline to week 12
Changes in low-level plasma viremia (single-copy assay)
Time frame: Baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2501, Case Clinical Research Site
Cleveland, United States
1401, University of Washington Positive Research CRS
Seattle, United States
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dasatinib in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intact HIV-1 reservoir size (time frame: Baseline and week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.