[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100121567":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":11,"locations":29,"responsibleParty":68,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":11,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Darunavir\u002Fr","EXPERIMENTAL",null,[13],"Drug: darunavir",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","darunavir","darunavir\u002Fr 800\u002F100 mg once daily by oral route, 48 weeks of treatment",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Jade Ghosn, MD","Centre Hsopitalier Universitaire de Bicêtre","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":28},"Christine Katlama, MD","Groupe Hospitalier Pitie-Salpetriere","STUDY_DIRECTOR",[30,42,51,56,62],{"facility":31,"status":11,"city":32,"state":11,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":11},"Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales","Le Kremlin-Bicêtre","94275","France","FR",{"type":37,"coordinates":38},"Point",[39,40],2.36073,48.81471,{"lat":40,"lon":39},{"facility":43,"status":11,"city":44,"state":11,"zip":45,"country":34,"countryCode":35,"cosmosGeoPoint":46,"geoPoint":50,"contacts":11},"Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne","Paris","75013",{"type":37,"coordinates":47},[48,49],2.3488,48.85341,{"lat":49,"lon":48},{"facility":52,"status":11,"city":44,"state":11,"zip":45,"country":34,"countryCode":35,"cosmosGeoPoint":53,"geoPoint":55,"contacts":11},"Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales",{"type":37,"coordinates":54},[48,49],{"lat":49,"lon":48},{"facility":57,"status":11,"city":44,"state":11,"zip":58,"country":34,"countryCode":35,"cosmosGeoPoint":59,"geoPoint":61,"contacts":11},"Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales","75015",{"type":37,"coordinates":60},[48,49],{"lat":49,"lon":48},{"facility":63,"status":11,"city":44,"state":11,"zip":64,"country":34,"countryCode":35,"cosmosGeoPoint":65,"geoPoint":67,"contacts":11},"Hôpital Tenon - Service des Maladies Infectieuses et Tropicales","75020",{"type":37,"coordinates":66},[48,49],{"lat":49,"lon":48},{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100121567","phase-3-study-of-protease-inhibitor-regimen-switch-in-hiv-1-infected-patients-with-undetectable-viral-load-to-prove-the-non-inferiority-of-once-daily-dose-regimen-versus-the-current-twice-daily-regimen-to-maintain-the-viral-load-under-the-limit-of-detection-100121567",false,"NCT00849160","Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.","Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir\u002FRitonavir 800\u002F100 mg Once a Day to Maintain the Viral Load Under the 50 Copies\u002Fml Limit of Detection After 24 Weeks of Treatment.","RADAR","Inclusion Criteria:\n\n* HIV-1 infected patients\n* Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month\n* At least two documented undetectable viral loads (under 50 copies\u002Fml) within the last 3 months\n* Naiive from darunavir\n* Free from any opportunistic infection\n* Creatinin \\\u003C 3N\n* ASAT \\& ALAT \\\u003C 5N\n* Haemoglobin \\> 7 g\u002Fdl\n* Platelets \\> 50 000\u002Fmm3\n* Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships\n* Signed informed consent\n\nExclusion Criteria:\n\n* HIV-2 infected patients\n* Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI\u002Fr BID)\n* Patients with a documented problem of treatment compliance within the last 12 months\n* Ongoing active treatment against any opportunistic infection or tuberculosis\n* Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and\u002Folr tolerance, and interfere with the protocol compliance\n* Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes\n* Patient already treated with darunavir\n* Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and\u002For maraviroc","ALL","18 Years",{"count":81,"type":82},100,"ACTUAL","INTERVENTIONAL",[85],"PHASE3","Darunavir boosted with ritonavir (darunavir\u002Fr) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir\u002Fr compared to the other ritonavir-boosted protease inhibitors (PI\u002Fr), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800\u002F100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir\u002Fr strain.\n\nThus, we propose to evaluate the efficacy of the darunavir\u002Fr association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.",[88,89],"HIV-1 Infection","HIV Infections",[91],"Treatment Experienced","COMPLETED","2014-01-21",{"date":95,"type":96},"2014-01-22","ESTIMATED",{"date":98,"type":11},"2009-05",{"date":100,"type":82},"2011-09",{"name":5,"class":6},5]