[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575637":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":66,"collaborators":68,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":26,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DORAVIRINE\u002FLAMIVUDINE combination","EXPERIMENTAL","Patients randomized to \"arm 1\" will receive the DORAVIRINE\u002FLAMIVUDINE combination: doravirin (PIFELTRO®) 100 mg 1 tablet per day + lamivudine (generic) 300 mg 1 tablet per day\n\nThe dosage is in accordance with the summary of product characteristics of each product.",[13],"Drug: Doravirine 100Mg Tab and Lamivudine 300 Mg Tab",{"label":15,"type":16,"description":17,"interventionNames":18},"Fixed DOLUTEGRAVIR\u002FLAMIVUDINE combination","ACTIVE_COMPARATOR","Patients randomized to arm 2 will receive the fixed combination DOLUTEGRAVIR\u002FLAMIVUDINE: dolutegravir 50 mg\u002Flamivudine 300 mg (DOVATO®) 1 tablet per day.\n\nThe dosage is in accordance with the summary of product characteristics of each product.",[19],"Drug: Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Doravirine 100Mg Tab and Lamivudine 300 Mg Tab","Participants randomised in the \"arm 1\" will receive the DORAVIRINE\u002FLAMIVUDINE combination: doravirine (PIFELTRO®) 100 mg 1 pill a day + lamivudine 300 mg 1 pill a day",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab","Participants randomised in the \"arm 2\" will receive the DTG\u002F3TC combination: dolutegravir 50 mg\u002Flamivudine 300 mg (DOVATO®) 1 pill a day",[15],[32],{"name":33,"affiliation":34,"role":35},"Romain PALICH, MD","Pitié-Salpêtrière Hospital","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Yasmine DUDOIT","CONTACT","+33 (0)142164181","yasmine.dudoit@aphp.fr",{"name":33,"role":39,"phone":43,"phoneExt":26,"email":44},"+33 (0)142160171","romain.palich@aphp.fr",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hôpital Pitié-Salpêtrière","RECRUITING","Paris","Île-de-France Region","75013","France","FR",{"type":55,"coordinates":56},"Point",[57,58],2.3488,48.85341,{"lat":58,"lon":57},[61,63],{"name":38,"role":39,"phone":62,"phoneExt":26,"email":41},"0033142164181",{"name":64,"role":39,"phone":65,"phoneExt":26,"email":44},"Romain PALICH, MD, PhD","0033142160171",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[69,72],{"name":70,"class":71},"ANRS, Emerging Infectious Diseases","OTHER_GOV",{"name":73,"class":74},"Organization providing support methodology coordination (Institut Pierre Louis d'Epidémiologie et de Santé Publique)","UNKNOWN","100575637","phase-2-doravirinelamivudine-dor3tc-as-a-maintenance-art-in-comparison-with-dolutegravirlamivudine-dtg3tc-in-plwh-successfully-100575637",false,"NCT06774872","Doravirine\u002FLamivudine (DOR\u002F3TC) as a Maintenance ART in Comparison With Dolutegravir\u002FLamivudine (DTG\u002F3TC) in PLWH Successfully","MODULO Trial: Doravirine\u002FLamivudine (DOR\u002F3TC) as a Maintenance ART in Comparison With Dolutegravir\u002FLamivudine (DTG\u002F3TC) in PLWH Successfully Treated With Three-drug Regimens at Inclusion","MODULO","Inclusion Criteria:\n\n* Adults ≥18 years;\n* Living with HIV-1;\n* With pVL \\\u003C50 copies\u002FmL for at least 24 months;\n* Under stable three-drug regimen including 2 NRTIs + 1 NNRTI or 1 INSTI or 1 boosted PI for at least 12 months;\n* Affiliated to the French Social Insurance;\n* Who have given their written consent to participate in the study\n\nExclusion Criteria:\n\n* HIV-2 co-infection;\n* Co-infection with hepatitis B virus (positive HBsAg and\u002For positive anti-HBc antibody with negative anti-HBs antibody);\n* Documented resistance mutation or association of resistance mutations, associated with partial or full resistance to doravirine, dolutegravir or lamivudine;\n* At least one resistance genotype is mandatory to include the patient:\n\n  * If there was no virological failure under NRTI, NNRTI and INSTI in the past:\n\n    * Pretherapeutic HIV-RNA genotype,\n    * OR, in case of no available HIV-RNA genotype, genotype on proviral HIV-DNA to performed before inclusion,\n  * In case of virological failure under NRTI, NNRTI and INSTI in the past:\n\n    * HIV-RNA genotype at time of virological failure,\n    * OR, in case of no available HIV-RNA genotype at time of failure, genotype on proviral HIV-DNA to performed before inclusion to be sure that the virus is fully sensitive to the study treatments,\n  * Past virological failure is defined as: 2 consecutive pVL ≥50 copies\u002FmL or one pVL ≥200 copies\u002FmL,\n  * Resistance genotypes will be interpretated with the last available ANRS algorithm.\n* Glomerular filtration rate \\\u003C50 mL\u002Fmin (CKD-EPI formula);\n* Comedications leading to drug-drug interaction with one of the 3 study drugs (cf. detailed protocol);\n* Pregnant or breastfeeding women, and women with age to be pregnant but refusing effective contraception, whether or not a desire for pregnancy is expressed;\n* Any clinal condition limiting the participation in a clinical trial: Immunocompromised conditions including active cancer or hematological malignancy, organ transplant or with transplant rejection within the last 6 months, immunosuppressive therapy, or other condition that in the opinion of the investigator could cause impaired host immunity\n* Protected adults (persons under legal guardianship or under \"sauvegarde de justice\" (judicial protection due to temporarily and slightly diminished mental or physical faculties)","ALL","18 Years",{"count":86,"type":87},408,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","The main objective of the MODULO trial is to compare (non-inferiority) the capacity of DOR\u002F3TC and DTG\u002F3TC two-drug regimens of maintain virological success at W48 in people living with HIV virus ( PLWH) with suppressed HIV plasma viral load (pVL) under three-drug regimen at inclusion.\n\nThe virological success is defined as no virological failure (2 consecutive pVL ≥50 copies\u002FmL or one pVL ≥50 copies\u002FmL followed with discontinuation of treatment or follow-up).",[93],"HIV-1-infection","2025-06-06",{"date":96,"type":97},"2025-06-11","ACTUAL",{"date":99,"type":97},"2025-04-30",{"date":101,"type":87},"2028-06-15",{"name":5,"class":6},1]