[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-interaction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-interaction":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":5},"100478607","pharmacogenomic-association-study-in-indian-children-with-acute-lymphoblastic-leukemia-100478607",false,"NCT05512169","Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia","Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)","MPGx-INDALL","Inclusion Criteria:\n\n* Age \\> 1 year old and ≤18 years old at enrolment\n* Previously untreated\n* ALL diagnosis confirmed by morphology and flow-cytometry\n* Indian origins\n* Fulfilling IciCle treatment protocol inclusion criteria and receiving treatment as per the protocol\n* Written Informed consent to participate in the study has to be signed by the participant\u002Fparent\u002Fguardian\n\nExclusion Criteria:\n\n* Previously tretaed patients\n* Patients with Down's syndrome\n* Patients with mature B-ALL","ALL","1 Year","18 Years",{"count":21,"type":22},556,"ESTIMATED","OBSERVATIONAL","A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva.\n\nThe study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.",[26,27,28,29,30,31,32,33],"ALL, Childhood","Pediatric Cancer","Toxicity, Drug","Adverse Drug Event","Relapse Leukemia","Drug Toxicity","Drug Effect","Drug Interaction",[35,36,37,38,39,40,41,42,43,44,45,46,47,48],"Pharmacogenetics","Pharmacogenomics","Genetic polymorphism","Sequencing","Genotyping","Indian","Pediatrics","SNP","gene variant","germline genetic variant","somatic variant","biomarker","steroid response","genetic predisposition","RECRUITING","2026-01-13",{"date":52,"type":53},"2026-01-15","ACTUAL",{"date":55,"type":53},"2022-12-01",{"date":57,"type":22},"2027-03-30",{"name":59,"class":60},"University of Geneva, Switzerland","OTHER",{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":70,"conditions":71,"keywords":80,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100571233","variation-in-drug-interactions-in-people-with-hiv-plwh-aged-60-years-and-older-100571233","NCT06717581","Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older.","Variation in Drug Interactions in People With HIV (PLWH) Aged 60 Years and Older on Stable Antiretroviral Therapy Making a Switch to Bictegravir\u002FTenofovir Alafenamide\u002FEmtricitabine","Inclusion Criteria:\n\n* Age \\> 60 years\n* Non-infectious comorbidities receiving drug therapy\n* Receiving BIC\u002FTAF\u002FFTC therapy at the time of of enrollment\n\nExclusion Criteria:\n\n* Genotypic resistance testing that present or past evidence of viral resistance to the integrase inhibitor class, to emtricitabine or to tenofovir\n* Severe acute infectious disease",{"count":69,"type":22},50,"Several cohort studies have recently shown a significant increase in the mean age of PLWH ( People Living With HIV) and in the prevalence of people in advanced age in the various cohorts, as a result of the marked increase in the mean life expectancy of these people achieved by modern antiretroviral combination therapies.\n\nHowever, the high prevalence of comorbidities exposes PLWH in old age to the need to take multiple drug treatments in addition to antiretroviral therapy, with the gradually increasing risk of unfavorable pharmacokinetic interactions between antiretroviral drugs and drugs taken to treat the comorbidities.\n\nThis project consists of an observational, cohort, retrospective, single-center study and aims to evaluate the variation in the number and type of clinically significant drug interactions between antiretroviral therapy and concomitant therapies in PLWH aged \\>60 years on stable antiretroviral therapy who, for any reason at the Clinician's discretion, have made a switch from ongoing antiretroviral therapy to the bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide regimen.",[72,33,73,74,75,76,77,78,79],"HIV Infections","Elderly Infection","Comorbidities and Coexisting Conditions","Cardiovascular Diseases","Metabolic Disease","Renal Disease","Osteoporosis Risk","Neoplasms",[81,82,83,84],"HIV","Drug Interactions","Retrovirus","Comorbidities","2024-12-01",{"date":87,"type":53},"2024-12-05",{"date":89,"type":53},"2024-10-11",{"date":91,"type":22},"2025-10-11",{"name":93,"class":60},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",1]