Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-06 @ 1:53 AM
Study NCT ID:
NCT05527418
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2022-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs', 'timeFrame': '52 weeks', 'description': 'Measured by number of AEs and SAEs'}], 'secondaryOutcomes': [{'measure': 'Antiretroviral capacity of dasatinib', 'timeFrame': 'at week 0 and 4', 'description': 'Measured by quantification of plasma HIV-1 viral load during 4-week administration of dasatinib monotherapy.'}, {'measure': 'Changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.', 'timeFrame': 'at week 0, 4, 16 and 52', 'description': 'Measured by changes in the viral reservoirs (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites)'}, {'measure': 'Changes in markers of inflammation and immune activation induced by dasatinib administration.', 'timeFrame': 'at week 0, 4, 16 and 52', 'description': 'Measured by changes in ultra-sensitive CRP, IL6, TNF alpha and CD4/CD8, CD25, CD69, CD38, HLA-DR+.'}, {'measure': 'Changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.', 'timeFrame': 'at week 0, 4, 16 and 52', 'description': 'Measured by NK phenotyping and in vitro replication inhibition tests.'}, {'measure': 'Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.', 'timeFrame': 'at week 1, 2, 3, 4, 8, 12, 16', 'description': 'Measured by Cmax'}, {'measure': 'Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.', 'timeFrame': 'at week 1, 2, 3, 4, 8, 12, 16', 'description': 'Measured by Cmin'}, {'measure': 'Impact of dasatinib on markers of senescence', 'timeFrame': 'at week 0, 4, 16 and 52', 'description': 'Measured by expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recent HIV-1 Infection']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years.\n* Documented asymptomatic HIV-1 infection of 3-12 months duration (all patients must have a positive Western blot, including the p31 band whose appearance indicates infection of more than 90 days duration).\n* Not having received ART\n* CD4 T-lymphocyte count\\> 350 / μl\n* Patient giving written informed consent\n\nExclusion Criteria:\n\n* Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection in screening.\n* 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.\n* Pregnancy or active breastfeeding\n* Ongoing or previous pleural effusion\n* Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma.\n* History of gastrointestinal or other bleeding.\n* Any concomitant treatment with potentially dangerous drug interaction with dasatinib.\n* Any clinical condition, at the opinion of the investigator, contraindicating participation (for example,\n* Active neoplastic disease, active concomitant infection, etc.)'}, 'identificationModule': {'nctId': 'NCT05527418', 'acronym': 'DASAHIVCURE', 'briefTitle': 'Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection', 'organization': {'class': 'OTHER', 'fullName': "Institut d'Investigacions Biomèdiques August Pi i Sunyer"}, 'officialTitle': 'Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection', 'orgStudyIdInfo': {'id': '2021-001288-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dasatinib', 'description': '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.', 'interventionNames': ['Drug: Dasatinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'description': 'Dasatinib monotherapy 70 mg/day, during 16 weeks.', 'armGroupLabels': ['Dasatinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo during 16 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eva Bonfill', 'role': 'CONTACT', 'email': 'bonfill@recerca.clinic.cat', 'phone': '932 257 400', 'phoneExt': '4198'}], 'facility': 'Eva Bonfill', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Eva Bonfill', 'role': 'CONTACT', 'email': 'bonfill@recerca.clinic.cat', 'phone': '+34 932275400', 'phoneExt': '4198'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eva Bonfill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Manager', 'investigatorFullName': 'Eva Bonfill', 'investigatorAffiliation': "Institut d'Investigacions Biomèdiques August Pi i Sunyer"}}}}