Recent HIV-1 InfectionPhase 2DASAHIVCURENCT05527418
Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
A Phase 2 study testing Dasatinib in people with Recent HIV-1 Infection, run by Eva Bonfill at 1 site in Spain.
Trial summary
Study to evaluate the safety, tolerability and antiretroviral activity of a new therapeutic strategy, based on the administration of dasatinib, an ITK, in patients with recent (3-12 months) asymptomatic HIV-1 infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recent HIV-1 Infection
- What is being tested?
- Dasatinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jan 2024to Dec 2026
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years.
- Documented asymptomatic HIV-1 infection of more than 3 months' duration (all patients must have a positive Western blot, including the p31 band whose appearance indicates infection of more than 90 days duration).
- Not having received ART
- CD4 T-lymphocyte count> 350 / μl
- Patient giving written informed consent
Who cannot join
- Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection in screening.
- ALT> 2 UNL, glomerular filtration rate <70 mL / 1.73 m2, leukocytes <4000 / mm3, total lymphocyte count <1000 / mm3, platelets <100,000 / mm3 or Hg <12g / dL.
- Pregnancy or active breastfeeding
- Ongoing or previous pleural effusion
- Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma.
- History of gastrointestinal or other bleeding.
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- Any concomitant treatment with potentially dangerous drug interaction with dasatinib.
- Any clinical condition, at the opinion of the investigator, contraindicating participation (for example,
- Active neoplastic disease, active concomitant infection, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Study to evaluate the safety, tolerability and antiretroviral activity of a new therapeutic strategy, based on the administration of dasatinib, an ITK, in patients with recent (3-12 months) asymptomatic HIV-1 infection.
- Conditions
- Recent HIV-1 Infection
- Being tested
- Dasatinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Dasatinib monotherapy 70 mg/day, during 16 weeks.
PlaceboDrug
Placebo during 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | Dasatinib monotherapy (70 mg/day) will be given for 4 weeks. Antiretroviral therapy (ART) based on unboosted integrase inhibitors will be initiated at week 4 (S4) and dasatinib will be continued with ART until week 12. Receives: Drug: Dasatinib |
| Placebo | Placebo comparator | Placebo monotherapy will be given for 4 weeks. Antiretroviral therapy (ART) based on unboosted integrase inhibitors will be initiated at week 4 (S4) and placebo will be continued with ART until week 12. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs
Measured by number of AEs and SAEs
Measured: 52 weeks
Secondary outcomes (7)
Antiretroviral capacity of dasatinib
Measured by quantification of plasma HIV-1 viral load during 4-week administration of dasatinib monotherapy.
Measured: at week 0 and 4
Changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.
Measured by changes in the viral reservoirs (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites)
Measured: at week 0, 4, 16 and 52
Changes in markers of inflammation and immune activation induced by dasatinib administration.
Measured by changes in ultra-sensitive CRP, IL6, TNF alpha and CD4/CD8, CD25, CD69, CD38, HLA-DR+.
Measured: at week 0, 4, 16 and 52
Changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.
Measured by NK phenotyping and in vitro replication inhibition tests.
Measured: at week 0, 4, 16 and 52
Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.
Measured by Cmax
Measured: at week 1, 2, 3, 4, 8, 12, 16
Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.
Measured by Cmin
Measured: at week 1, 2, 3, 4, 8, 12, 16
Impact of dasatinib on markers of senescence
Measured by expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.
Measured: at week 0, 4, 16 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start26 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recent HIV-1 InfectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eva Bonfill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Bonfill, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527418
- Sponsor's protocol ID
- 2021-001288-26
- Acronym
- DASAHIVCURE
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
- ClinicalTrials.gov ID
- NCT05527418
- Acronym / sponsor ID
- DASAHIVCURE / 2021-001288-26
- Conditions
- Recent HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Eva BonfillUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Sep 2022 (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.
Study to evaluate the safety, tolerability and antiretroviral activity of a new therapeutic strategy, based on the administration of dasatinib, an ITK, in patients with recent (3-12 months) asymptomatic HIV-1 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: DasatinibDasatinib monotherapy (70 mg/day) will be given for 4 weeks. Antiretroviral therapy (ART) based on unboosted integrase inhibitors will be initiated at week 4 (S4) and dasatinib will be continued with ART until week 12. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo monotherapy will be given for 4 weeks. Antiretroviral therapy (ART) based on unboosted integrase inhibitors will be initiated at week 4 (S4) and placebo will be continued with ART until week 12. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 65 years.
- Documented asymptomatic HIV-1 infection of more than 3 months' duration (all patients must have a positive Western blot, including the p31 band whose appearance indicates infection of more than 90 days duration).
- Not having received ART
- CD4 T-lymphocyte count> 350 / μl
- Patient giving written informed consent
Key exclusion criteria (9 listed)
- Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection in screening.
- ALT> 2 UNL, glomerular filtration rate <70 mL / 1.73 m2, leukocytes <4000 / mm3, total lymphocyte count <1000 / mm3, platelets <100,000 / mm3 or Hg <12g / dL.
- Pregnancy or active breastfeeding
- Ongoing or previous pleural effusion
- Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma.
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 |
|---|---|---|
| DasatinibDasatinib monotherapy 70 mg/day, during 16 weeks. | Drug | Dasatinib |
| PlaceboPlacebo during 16 weeks. | Drug | Placebo |
Primary outcome
Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs
Time frame: 52 weeks
Measured by number of AEs and SAEs
7 secondary outcomes
Antiretroviral capacity of dasatinib
Time frame: at week 0 and 4
Changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.
Time frame: at week 0, 4, 16 and 52
Changes in markers of inflammation and immune activation induced by dasatinib administration.
Time frame: at week 0, 4, 16 and 52
Changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.
Time frame: at week 0, 4, 16 and 52
Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.
Time frame: at week 1, 2, 3, 4, 8, 12, 16
Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.
Time frame: at week 1, 2, 3, 4, 8, 12, 16
Impact of dasatinib on markers of senescence
Time frame: at week 0, 4, 16 and 52
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 6 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Recent HIV-1 Infection, run by Eva Bonfill at 1 site in Spain.
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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs (time frame: 52 weeks). 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 6 Jul 2026.