[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501800":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":53,"responsibleParty":117,"collaborators":119,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":140,"minAge":141,"maxAge":47,"enrollmentInfo":142,"targetDuration":47,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":56,"whyStopped":47,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Event-driven PrEP with TDF\u002FFTC","ACTIVE_COMPARATOR","Participants randomly assigned to the event-driven TDF\u002FFTC arm will be instructed to take a loading dose of two single tablets containing coformulated TDF\u002FFTC (300\u002F200mg) 2 to 24 hours before sexual intercourse, followed by a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills.",[13],"Drug: TDF\u002FFTC 300mg\u002F200mg fixed-dose combination tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Event-driven PrEP with TAF\u002FFTC","EXPERIMENTAL","Participants randomly assigned to the event-driven TAF\u002FFTC arm will be instructed to take one single tablet containing coformulated TAF\u002FFTC (25\u002F200mg) with or without food 2 to 24 hours before sexual intercourse followed by a second pill 24 hours after the first drug intake. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse and then a last pill 24 hours later.",[19],"Drug: TAF\u002FFTC 25mg\u002F200mg fixed-dose combination tablets",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","TDF\u002FFTC 300mg\u002F200mg fixed-dose combination tablets","Event-driven dosing regimen",[9],[27],"Truvada",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"TAF\u002FFTC 25mg\u002F200mg fixed-dose combination tablets","Event-driven dosing regimen.",[15],[33],"Descovy",[35,39],{"name":36,"affiliation":37,"role":38},"Geoffroy LIEGEON","Infectious Diseases Department, Saint-Louis Hospital, Paris, France","STUDY_DIRECTOR",{"name":40,"affiliation":41,"role":38},"Sumet ONGWANDEE","Office of the Senior Expert Committee, Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Geoffroy LIEGEON, MD, PhD","CONTACT","+33 142494991",null,"geoffroy.liegeon@aphp.fr",{"name":50,"role":45,"phone":51,"phoneExt":47,"email":52},"Gonzague JOURDAIN, MD, PhD",": +66 8 1883 0065","gonzague.jourdain@phpt.org",[54,76,88,107],{"facility":55,"status":56,"city":57,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"AP-HP - Hospital Lariboisière","RECRUITING","Paris","France","FR",{"type":61,"coordinates":62},"Point",[63,64],2.3488,48.85341,{"lat":64,"lon":63},[67,71,73],{"name":68,"role":45,"phone":69,"phoneExt":47,"email":70},"DIEMER Myriam MD","+ 33 149958037","myriam.diemer@aphp.fr",{"name":72,"role":45,"phone":46,"phoneExt":47,"email":48},"Geoffroy LIEGEON MD",{"name":74,"role":75,"phone":47,"phoneExt":47,"email":47},"LIEGEON","PRINCIPAL_INVESTIGATOR",{"facility":77,"status":56,"city":57,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"AP-HP - Hôpital Saint-Louis",{"type":61,"coordinates":79},[63,64],{"lat":64,"lon":63},[82,86],{"name":83,"role":45,"phone":84,"phoneExt":47,"email":85},"Jean Michel MOLINA, MD","+33 142494512","jean-michel.molina@aphp.fr",{"name":87,"role":45,"phone":46,"phoneExt":47,"email":48},"Geoffroy LIEGEON, MD",{"facility":89,"status":56,"city":90,"state":47,"zip":47,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"MPlus Clinic","Chiang Mai","Thailand","TH",{"type":61,"coordinates":94},[95,96],98.98468,18.79038,{"lat":96,"lon":95},[99,103],{"name":100,"role":45,"phone":101,"phoneExt":47,"email":102},"Thitipan AKKARASEREENON MD","+66 53283108","d_thitipan@hotmail.com",{"name":104,"role":45,"phone":105,"phoneExt":47,"email":106},"Sumet ONGWANDEE MD","+66 25903817","sumet_o@yahoo.com",{"facility":108,"status":56,"city":90,"state":47,"zip":47,"country":91,"countryCode":92,"cosmosGeoPoint":109,"geoPoint":111,"contacts":112},"STIs Clinic of the Office of Disease Prevention and Control Region 1",{"type":61,"coordinates":110},[95,96],{"lat":96,"lon":95},[113,115],{"name":114,"role":45,"phone":105,"phoneExt":47,"email":102},"Thitipan AKKARASEREENON, MD",{"name":116,"role":45,"phone":105,"phoneExt":47,"email":106},"Sumet ONGWANDEE, MD",{"type":118,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[120,123,125,128],{"name":121,"class":122},"Chiang Mai University, Thailand","UNKNOWN",{"name":124,"class":6},"Ministry of Health, Thailand",{"name":126,"class":127},"Assistance Publique - Hôpitaux de Paris","OTHER",{"name":129,"class":130},"Gilead Sciences","INDUSTRY","100501800","phase-3-efficacy-acceptability-and-safety-of-event-driven-hiv-prep-using-tafftc-in-msm-in-thailand-and-france-100501800",false,"NCT05813964","Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF\u002FFTC in MSM in Thailand and France.","A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF\u002FFTC in Men Who Have Sex With Men in Thailand and France","SimpPrEP","Inclusion Criteria:\n\n* Male at birth age ≥ 18 years old\n* Reporting having sex with men\n* Negative 4th generation HIV-1 and HIV-2 test\n* Reporting condomless anal sex with men not more often than two days during the previous month and able to plan their sexual activity\n* Risk of HIV acquisition based on self-report of at least one of the following behaviors during the 6 months before enrollment: condomless anal sex with at least 2 different sexual partners, sexually transmitted infection (rectal chlamydia and\u002For rectal gonorrhea and\u002For syphilis), provided or received money goods or favor in exchange of sex, binge drinking or use of non-injectable recreational drugs.\n* Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months\n* In France: Person affiliated with or benefiting from a social security system (article L1121-11of the public health code in France)\n\nNon-inclusion criteria:\n\n* Symptoms and\u002For clinical signs consistent with an acute HIV infection\n* Women and trans women\n* Taking feminizing hormone therapy\n* Positive HIV test result at screening or enrollment even if HIV infection is not confirmed\n* Positive hepatitis B surface antigen test\n* ALT or AST \\> 4 ULN\n* Estimated glomerular filtration rate \\\u003C 60mL\u002Fmin\u002F1.73m²\n* History of chronic kidney disease, osteoporosis, osteopenia or pathological fracture not related to trauma\n* Hypersensitivity to the study products F\u002FTDF or F\u002FTAF\n* Past or concurrent participation in a HIV vaccine trial or concurrent participation in another clinical trial without the agreement of the principal investigators of the two trials\n* Use of intravenous drugs within the last 12 months\n* Person under legal guardianship\n* Not likely to comply with the clinical trial procedures or with any condition incompatible with study participation, upon the investigator's judgement.\n* Ongoing Post-Exposure Prophylaxis (PEP) for HIV",true,"MALE","18 Years",{"count":143,"type":144},524,"ESTIMATED","INTERVENTIONAL",[147],"PHASE3","The purpose of this study is to evaluate the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF\u002FFTC in HIV-uninfected cisgender men who have sex with men (MSM).\n\nPrimary objective: To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F\u002FTAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.",[150],"HIV\u002FAIDS",[152,153,154,155],"PrEP exposure prophylaxis (PrEP)","On-demand","Event-driven","TAF","2025-06-17",{"date":158,"type":159},"2025-06-20","ACTUAL",{"date":161,"type":159},"2024-06-05",{"date":163,"type":144},"2027-05",{"name":5,"class":6},4]