Primary purpose of this study is to compare the efficacy and safety of two different
nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application)
and of atazanavir/ritonavir (Reyataz/Norvir), all on an emtricitabine/tenofovir disoproxil
fumarate (DF) (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg
twice daily, or NVP 400 mg once daily , or ritonavir-boosted atazanavir (ATZ/r), all in
combination with emtricitabine (FTC) and tenofovir DF (TDF).
All patients receiving NVP will start at 200 mg once daily for 2 weeks, because it has been
demonstrated that this lead-in dosing regimen reduces the frequency of NVP-induced rash. At
Visit 3 (Week 2), patients increase the NVP dose to either 200 mg twice daily or to 400 mg
once daily. Patients receiving ATZ/r will be treated with ATZ 300 mg once daily, boosted by
100 mg ritonavir (RTV) once daily. Background antiretroviral therapy for all patients
consists of one tablet of Truvada. Treatment duration is 48 weeks (primary endpoint) with an
extension to 144 weeks. Patients may also participate in the metabolic sub-study, comparing
NVP and ATZ/r for signs and symptoms of lipodystrophy and serum lipid/glycaemic
abnormalities.
Treatment Response at Week 48 (TLOVR Algorithm)Proportion of Patients With VL < 50 Copies/ml
Proportion of Patients With VL < 400 Copies/ml
Change in CD4+ Count From Baseline
Change in Framingham Score From Baseline
Change in Mental Health Summary (MHS) Score From Baseline
Change in Physical Health Summary (PHS) Score From Baseline
Number of Patients Hospitalized
Non-scheduled Physician Visits
Genotypic Resistance Associated With Virologic Failure
Treatment-emergent AIDS-defining Illness
Treatment-emergent AIDS-defining Illness Leading to Death
Lipodystrophy
Serum Lipid Abnormalities
Glycaemic Abnormalities
Treatment Response at Week 96
Treatment Response at Week 144
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
Proportion of Patients With Virologic Failure at Week 48, 96, 144
Time to Treatment Response (First Confirmed VL<50 Copies/mL)
Time to Loss of Virologic Response (Rebound)
Time to Treatment Failure
Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
Proportion of Patients Reporting Rash of Any Severity
Proportion of Patients Reporting Hepatic Events of Any Severity
Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity
Change of Cholesterol Values From Baseline to Week 48, 96, 144
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
Change of hsCRP From Baseline to Week 48, 96, 144
Change of Total Triglycerides From Baseline to Week 48, 96, 144
Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
1100.1470.54004 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina
1100.1470.54002 Boehringer Ingelheim Investigational Site, Córdoba, Argentina
1100.1470.54003 Boehringer Ingelheim Investigational Site, Mar del Plata, Argentina
1100.1470.54001 Boehringer Ingelheim Investigational Site, Rosario, Argentina
1100.1470.49001 Boehringer Ingelheim Investigational Site, Berlin, Germany
1100.1470.49002 Boehringer Ingelheim Investigational Site, Berlin, Germany
1100.1470.49003 Boehringer Ingelheim Investigational Site, Bochum, Germany
1100.1470.49018 Boehringer Ingelheim Investigational Site, Bonn, Germany
1100.1470.49014 Boehringer Ingelheim Investigational Site, Düsseldorf, Germany
1100.1470.49008 Boehringer Ingelheim Investigational Site, Erlangen, Germany
1100.1470.49036 Boehringer Ingelheim Investigational Site, Frankfurt am Main, Germany
1100.1470.49035 Boehringer Ingelheim Investigational Site, Frankfurt, Germany
1100.1470.49033 Boehringer Ingelheim Investigational Site, Freiburg/Breisgau, Germany
1100.1470.49016 Boehringer Ingelheim Investigational Site, Hamburg, Germany
1100.1470.49031 Boehringer Ingelheim Investigational Site, Hamburg, Germany
1100.1470.49037 Boehringer Ingelheim Investigational Site, Hamburg, Germany
1100.1470.49020 Boehringer Ingelheim Investigational Site, Hannover, Germany
1100.1470.49038 Boehringer Ingelheim Investigational Site, Magdeburg, Germany
1100.1470.49034 Boehringer Ingelheim Investigational Site, München, Germany
1100.1470.49000 Boehringer Ingelheim Investigational Site, Ulm, Germany
1100.1470.49032 Boehringer Ingelheim Investigational Site, Würzburg, Germany
1100.1470.39001 Boehringer Ingelheim Investigational Site, Bergamo, Italy
1100.1470.39003 Boehringer Ingelheim Investigational Site, Bologna, Italy
1100.1470.39012 Ospedale Sant'Anna, Como, Italy
1100.1470.39006 Boehringer Ingelheim Investigational Site, Ferrara, Italy
1100.1470.39010 Boehringer Ingelheim Investigational Site, Lecco, Italy
1100.1470.39004 Boehringer Ingelheim Investigational Site, Torino, Italy
1100.1470.39009 Boehringer Ingelheim Investigational Site, Torrette Di Ancona, Italy
1100.1470.39007 Boehringer Ingelheim Investigational Site, Varese, Italy
1100.1470.55006 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico
1100.1470.55004 Boehringer Ingelheim Investigational Site, Col Obregón, Mexico
1100.1470.55008 Boehringer Ingelheim Investigational Site, Col. Los Filtros, San Luis Potosí, Mexico
1100.1470.55001 Boehringer Ingelheim Investigational Site, Col. Toriello Guerra, Mexico
1100.1470.55007 Boehringer Ingelheim Investigational Site, Guadalajara Jal., Mexico
1100.1470.55003 Boehringer Ingelheim Investigational Site, Tlalpan-México D,F, Mexico
1100.1470.48003 Boehringer Ingelheim Investigational Site, Bydgoszcz, Poland
1100.1470.48001 Boehringer Ingelheim Investigational Site, Chorzow, Poland
1100.1470.48002 Boehringer Ingelheim Investigational Site, Szczecin, Poland
1100.1470.48004 Boehringer Ingelheim Investigational Site, Warsaw, Poland
1100.1470.35102 Boehringer Ingelheim Investigational Site, Cascais, Portugal
1100.1470.35101 Boehringer Ingelheim Investigational Site, Lisboa, Portugal
1100.1470.35103 Boehringer Ingelheim Investigational Site, Porto, Portugal
1100.1470.40001 Boehringer Ingelheim Investigational Site, Bucharest, Romania
1100.1470.40002 Boehringer Ingelheim Investigational Site, Bucharest, Romania
1100.1470.34013 Boehringer Ingelheim Investigational Site, Alcalá de Henares (Madrid), Spain
1100.1470.34008 Boehringer Ingelheim Investigational Site, Badalona, Spain
1100.1470.34002 Boehringer Ingelheim Investigational Site, Barcelona, Spain
1100.1470.34003 Boehringer Ingelheim Investigational Site, Barcelona, Spain
1100.1470.34009 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, Spain
1100.1470.34010 Boehringer Ingelheim Investigational Site, Madrid, Spain
1100.1470.34012 Boehringer Ingelheim Investigational Site, Madrid, Spain
1100.1470.34014 Boehringer Ingelheim Investigational Site, Madrid, Spain
1100.1470.34015 Boehringer Ingelheim Investigational Site, Madrid, Spain
1100.1470.34019 Boehringer Ingelheim Investigational Site, Malaga, Spain
1100.1470.34007 Boehringer Ingelheim Investigational Site, Sabadell (Barcelona), Spain
1100.1470.34004 Boehringer Ingelheim Investigational Site, San Sebastian, Spain
1100.1470.34006 Boehringer Ingelheim Investigational Site, Santa Cruz de Tenerife, Spain
1100.1470.34011 Boehringer Ingelheim Investigational Site, Vigo, Spain
1100.1470.41004 Boehringer Ingelheim Investigational Site, Bern, Switzerland
1100.1470.41001 Boehringer Ingelheim Investigational Site, Lugano, Switzerland
1100.1470.41003 Boehringer Ingelheim Investigational Site, St. Gallen, Switzerland
1100.1470.41002 Boehringer Ingelheim Investigational Site, Zürich, Switzerland
1100.1470.44004 Boehringer Ingelheim Investigational Site, Birmingham, United Kingdom
1100.1470.44001 Boehringer Ingelheim Investigational Site, London, United Kingdom
1100.1470.44002 Boehringer Ingelheim Investigational Site, London, United Kingdom
1100.1470.44005 Boehringer Ingelheim Investigational Site, London, United Kingdom
1100.1470.44006 Boehringer Ingelheim Investigational Site, London, United Kingdom
1100.1470.44003 Boehringer Ingelheim Investigational Site, Manchester, United Kingdom