[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100066892":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":18,"centralContacts":7,"locations":27,"responsibleParty":7,"collaborators":40,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":7,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":7,"enrollmentInfo":53,"targetDuration":7,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":7,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"French National Agency for Research on AIDS and Viral Hepatitis","OTHER_GOV",null,[9,12,14,16],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","nelfinavir",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"lopinavir\u002Fr",{"type":10,"name":15,"description":7,"armGroupLabels":7,"otherNames":7},"indinavir",{"type":10,"name":17,"description":7,"armGroupLabels":7,"otherNames":7},"ritonavir",[19,23],{"name":20,"affiliation":21,"role":22},"Dominique Salmon, MD","Service de Medecine Interne Hopital Cochin Paris","PRINCIPAL_INVESTIGATOR",{"name":24,"affiliation":25,"role":26},"France Mentre, MD","Inserm EMI 03 57","STUDY_CHAIR",[28],{"facility":29,"status":7,"city":30,"state":7,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":7},"Service de Medecine Interne Hopital Cochin","Paris","75014","France","FR",{"type":35,"coordinates":36},"Point",[37,38],2.3488,48.85341,{"lat":38,"lon":37},[41],{"name":42,"class":43},"Hoffmann-La Roche","INDUSTRY","100066892","evaluation-of-therapeutic-drug-monitoring-of-protease-inhibitors-on-virologic-success-and-tolerance-of-highly-active-antiretroviral-therapy-haart-100066892",false,"NCT00122590","Evaluation of Therapeutic Drug Monitoring of Protease Inhibitors on Virologic Success and Tolerance of Highly Active Antiretroviral Therapy (HAART)","Prospective Trial to Evaluate How Therapeutic Drug Monitoring of Protease Inhibitors Increases Virologic Success and Tolerance of HAART (ANRS 111 COPHAR2)","Inclusion Criteria:\n\n* Patients infected with HIV-1\n* Needing an antiretroviral treatment according to standard of care\n* HIV viral load greater than 1000 copies\u002Fml\n* Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors\n* PI-naive\n* Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y\u002FF, Q151M, M184V\u002FI, V75M\u002FS, L74V) and if 3 nucleoside analogues are still active except for didanosine.\n\nExclusion Criteria:\n\n* Pregnant women and nursing mothers\n* Acute HIV infection\n* Diabetes\n* Renal insufficiency with creatinine clearance below 30 ml\u002Fmin\n* Cardiac insufficiency\n* Hepatic insufficiency with TP below 60%\n* Treatment with known interactions with PI\n* Chemotherapy against Kaposi's sarcoma, lymphoma, neoplasia\n* Treatment containing interferon (INF) or interleukin-2 (IL2) or HIV- immune vaccine\n* Treatment with hypolipemic drugs\n* Laxative treatment\n* Previous renal colic\n* Diarrhoea with more than 5 stools\u002Fday since one week","ALL","18 Years",{"count":54,"type":7},115,"INTERVENTIONAL",[57],"NA","This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring, from weeks 2 to 24, after the initiation of HAART including either indinavir\u002Fr, lopinavir\u002Fr or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were out of the range given for each protease inhibitor (PI), the PI dose was adjusted.",[60],"HIV Infections",[62,11,63,15,64],"protease inhibitors","lopinavir","Pharmacokinetics","TERMINATED","2005-07-29",{"date":68,"type":69},"2005-08-01","ESTIMATED",{"date":71,"type":7},"2002-07",{"date":73,"type":7},"2005-03",{"name":5,"class":6},1]