[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479779":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":47,"interventions":60,"overallOfficials":37,"centralContacts":68,"locations":75,"responsibleParty":90,"collaborators":37,"id":93,"slug":37,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":37,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":37,"overallStatus":77,"whyStopped":37,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Institut d'Investigacions Biomèdiques August Pi i Sunyer","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs","Measured by number of AEs and SAEs","52 weeks",[14,18,22,25,28,32,34],{"measure":15,"description":16,"timeFrame":17},"Antiretroviral capacity of dasatinib","Measured by quantification of plasma HIV-1 viral load during 4-week administration of dasatinib monotherapy.","at week 0 and 4",{"measure":19,"description":20,"timeFrame":21},"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)","at week 0, 4, 16 and 52",{"measure":23,"description":24,"timeFrame":21},"Changes in markers of inflammation and immune activation induced by dasatinib administration.","Measured by changes in ultra-sensitive CRP, IL6, TNF alpha and CD4\u002FCD8, CD25, CD69, CD38, HLA-DR+.",{"measure":26,"description":27,"timeFrame":21},"Changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.","Measured by NK phenotyping and in vitro replication inhibition tests.",{"measure":29,"description":30,"timeFrame":31},"Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.","Measured by Cmax","at week 1, 2, 3, 4, 8, 12, 16",{"measure":29,"description":33,"timeFrame":31},"Measured by Cmin",{"measure":35,"description":36,"timeFrame":21},"Impact of dasatinib on markers of senescence","Measured by expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":44},"DOUBLE",[45,46],"PARTICIPANT","INVESTIGATOR",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Dasatinib","EXPERIMENTAL","Dasatinib monotherapy (70 mg\u002Fday) 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.",[53],"Drug: Dasatinib",{"label":55,"type":56,"description":57,"interventionNames":58},"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.",[59],"Drug: Placebo",[61,65],{"type":62,"name":49,"description":63,"armGroupLabels":64,"otherNames":37},"DRUG","Dasatinib monotherapy 70 mg\u002Fday, during 16 weeks.",[49],{"type":62,"name":55,"description":66,"armGroupLabels":67,"otherNames":37},"Placebo during 16 weeks.",[55],[69],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},"Eva Bonfill","CONTACT","+34 932275400","4198","bonfill@recerca.clinic.cat",[76],{"facility":70,"status":77,"city":78,"state":37,"zip":37,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"RECRUITING","Barcelona","Spain","ES",{"type":82,"coordinates":83},"Point",[84,85],2.15899,41.38879,{"lat":85,"lon":84},[88],{"name":70,"role":71,"phone":89,"phoneExt":73,"email":74},"932 257 400",{"type":91,"investigatorFullName":70,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"SPONSOR_INVESTIGATOR","Clinical Research Manager","100479779",false,"NCT05527418","Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection","DASAHIVCURE","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 \u002F μl\n* Patient giving written informed consent\n\nExclusion Criteria:\n\n* Active HBV (HBsAg+ or DNA+) and\u002For HCV (RNA+) infection in screening.\n* ALT\\> 2 UNL, glomerular filtration rate \\\u003C70 mL \u002F 1.73 m2, leukocytes \\\u003C4000 \u002F mm3, total lymphocyte count \\\u003C1000 \u002F mm3, platelets \\\u003C100,000 \u002F mm3 or Hg \\\u003C12g \u002F 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.)","ALL","18 Years","65 Years",{"count":103,"type":104},24,"ESTIMATED","INTERVENTIONAL",[107],"PHASE2","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.",[110],"Recent HIV-1 Infection","2025-04-30",{"date":113,"type":114},"2025-05-01","ACTUAL",{"date":116,"type":114},"2024-01-26",{"date":118,"type":104},"2026-06",{"name":70,"class":6},1]