[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100072710":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":17,"locations":28,"responsibleParty":7,"collaborators":7,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":7,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":7,"enrollmentInfo":56,"targetDuration":7,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":71,"whyStopped":7,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"MEDEX","OTHER",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Nevirapine",[13],{"name":14,"affiliation":15,"role":16},"REY MR DAVID, M.D","CISIH CHRU STRASBOURG","PRINCIPAL_INVESTIGATOR",[18,24],{"name":19,"role":20,"phone":21,"phoneExt":22,"email":23},"REY DAVID, M.D","CONTACT","0388116451","33","david.rey@chru-strasbourg.fr",{"name":25,"role":20,"phone":26,"phoneExt":22,"email":27},"LARGUIER JEAN-SYLVAIN, M.D","0437451717","daufin@rcts.fr",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Cisih, Clinique Medical A, Hopitaux Universitaires","RECRUITING","Strasbourg","Alsace","67091","France","FR",{"type":38,"coordinates":39},"Point",[40,41],7.74553,48.58392,{"lat":41,"lon":40},[44,46],{"name":19,"role":20,"phone":45,"phoneExt":22,"email":23},"0388116333",{"name":19,"role":16,"phone":7,"phoneExt":7,"email":7},"100072710","phase-3-zidovudine--lamivudine--nevirapine-twice-daily-versus-tenofovir--lamivudine--nevirapine-once-daily-in-arv-naive-patients-100072710",false,"NCT00199979","Zidovudine \u002F Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients","Multicenter, Randomized, Open-Label Trial, Assessing the Efficacy of Zidovudine, Lamivudine and Nevirapine Combination Administered Twice Daily, Versus the Association of Tenofovir, Lamivudine and Nevirapine, Once Daily, in Antiretroviral Naive HIV-1 Infected Patients","Inclusion Criteria:\n\n* HIV-1 infection, confirmed by a western-blot assay, at least 6 months after primary infection\n* Age \\> or equal to 18 years of age\n* No prior antiretroviral treatment\n* Karnofsky superior to 60%\n* CD4 T cells \\\u003C 350\u002FµL (2 measures, with at least a 1-month interval) in women, study will be proposed when CD4 cell count is below 250\u002FµL, as nevirapine liver toxicity increases (X10) when CD4 are \\> 250\u002FµL\n* Written informed consent\n\nExclusion Criteria:\n\n* HIV-2 infection or co-infection\n* Prior antiretroviral treatment\n* Intolerance, or contraindication to investigational drugs\n* Pregnant or breast-feeding woman, or plan to become pregnant\n* Active untreated opportunistic infections (AIDS-defining illness, category C, CDC, 1993), or malignancies requiring cytotoxic chemotherapy\n* Biological criteria: hemoglobin \\\u003C 10 G\u002FDL, neutrophil count \\\u003C 1000\u002FµL, platelets \\\u003C 50000\u002FµL, creatinine \\> 2N, ASAT or ALAT \\> 2.5N, bilirubin \\> 2N, hypophosphatemia\n* Prevision of poor adherence\n* HBC co-infection (Ag Hbs positive) or HVC co-infection (positive HCV PCR)\n* Liver failure, alcohol abuse\n* Treatment administration not recommended with investigational drugs\n* Interferon, interleukin, or HIV vaccine treatment\n* Informed consent not obtained","ALL","18 Years",{"count":57,"type":7},250,"INTERVENTIONAL",[60],"PHASE3","The study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine\u002Flamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350\u002FµL or below 15%, whatever the viral load. Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.",[63,64],"Hiv Infection With Antiretroviral Therapy Indication","CD4 Below 350\u002FµL or Below 15%",[66,11,67,68,69,70],"Antiretroviral Therapy","HIV Viral Load","Adherence","Quality of Life","Resistance Mutations","UNKNOWN","2005-12-15",{"date":74,"type":75},"2005-12-16","ESTIMATED",{"date":77,"type":7},"2005-04",{"date":79,"type":7},"2008-06",{"name":5,"class":6},1]