NCT00561925
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
Sponsored by Boehringer Ingelheim
The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.
Inclusion criteria: 1. Signed informed consent in accordance with Good Clinical Practice and local regulatory requirements prior to trial participation 2. HIV-1 infected males or females \>= 18 years of age with positive serology (ELISA) confirmed by Western blot 3. No previous antiretroviral treatment 4. Males with CD4+ counts \>50 - \<400 cells/ml or females with CD4+ counts \>50-\<250 cells/ml 5. Adequate renal function defined as a calculated creatinine clearance (CLCr) greater than or equal to 50 mL/min according to the Cockcroft-Gault formula as follows: Male: (140 - age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (mL/min). Female: (140 - age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (mL/min). 6. Karnofsky score \>70 (see Appendix 10.4) 7. An HIV-1 viral load of 1,000 copies/mL 8. Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2 9. Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Appendix 10.3) during the study. 10. For centers participating in the PK substudy only: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. Refusal to participate in the PK substudy is not an exclusion criterion for participation in the trial. Only study centers with previous experience and equipped in handling PK samples are eligible for participation in the substudy. Exclusion criteria: 1. Active drug abuse or chronic alcoholism at the investigator's discretion 2. Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive 3. Female patients of child-bearing potential who: are pregnant at screening; are breast feeding; are planning to become pregnant; are not willing to use a barrier method of contraception, or; are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives Note: During participation in this study, females and males have to use barrier methods of contraception in addition or instead of ethinyl estradiol containing oral contraceptives. 4. Laboratory parameters \>DAIDS Grade 2 5. ALT/AST \> DAIDS Grade 1 6. Hypersensitivity to any ingredients of the test products 7. Previous use of Viramune® (nevirapine) or any other antiretroviral agents (does not include use of single dose NVP for the prevention of mother to child transmission) 8. Resistance to NNRTIs or either one of the components of Truvada® (emtricitabine or tenofovir disoproxil fumarate) or lamivudine (3TC) based on HIV-1 genotypic resistance testing report obtained at screening 9. Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information 10. Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial 11. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2) 12. Patients who have been diagnosed with malignant disease 13. Patients who in the opinion of the investigator are not candidates for inclusion in the study 14. Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma 15. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
1100.1486.0040 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Beverly Hills, California, United States
1100.1486.0059 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1100.1486.0035 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1100.1486.0025 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1100.1486.0034 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
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Los Angeles, California, United States
1100.1486.0032 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
1100.1486.0028 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1100.1486.0023 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia, United States
1100.1486.0029 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia, United States
1100.1486.0048 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
1100.1486.0043 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1100.1486.0012 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1100.1486.0007 Boehringer Ingelheim Investigational Site
Miami Beach, Florida, United States
1100.1486.0039 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1100.1486.0050 Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
1100.1486.0014 Boehringer Ingelheim Investigational Site
Wilton Manors, Florida, United States
1100.1486.0031 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1100.1486.0010 Boehringer Ingelheim Investigational Site
Macon, Georgia, United States
1100.1486.0053 Boehringer Ingelheim Investigational Site
Boise, Idaho, United States
1100.1486.0002 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1100.1486.0026 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1100.1486.0020 Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
1100.1486.0019 Boehringer Ingelheim Investigational Site
Berkley, Michigan, United States
1100.1486.0006 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
1100.1486.0027 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
1100.1486.0055 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1100.1486.0003 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina, United States
1100.1486.0005 Boehringer Ingelheim Investigational Site
Akron, Ohio, United States
1100.1486.0004 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1100.1486.0018 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
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Dallas, Texas, United States
1100.1486.0044 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1100.1486.0054 Boehringer Ingelheim Investigational Site
Harlingen, Texas, United States
1100.1486.0009 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1100.1486.0046 Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
1100.1486.5401 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5402 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5404 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5407 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5408 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5403 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
1100.1486.5409 Boehringer Ingelheim Investigational Site
Quilmes, Argentina
1100.1486.5405 Boehringer Ingelheim Investigational Site
Rosario, Argentina
1100.1486.6101 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
1100.1486.6102 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
1100.1486.6104 Boehringer Ingelheim Investigational Site
Surry Hills, New South Wales, Australia
1100.1486.6103 Boehringer Ingelheim Investigational Site
Brisbane, Queensland, Australia
1100.1486.3208 Boehringer Ingelheim Investigational Site
Bruges, Belgium
1100.1486.3201 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1100.1486.3203 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1100.1486.3205 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1100.1486.3207 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1100.1486.3209 Boehringer Ingelheim Investigational Site
Charleroi, Belgium
1100.1486.3202 Boehringer Ingelheim Investigational Site
Ghent, Belgium
1100.1486.3204 Boehringer Ingelheim Investigational Site
Liège, Belgium
1100.1486.3206 Boehringer Ingelheim Investigational Site
Liège, Belgium
1100.1486.2605 Boehringer Ingelheim Investigational Site
Francistown, Botswana
1100.1486.2601 Boehringer Ingelheim Investigational Site
Gaborone, Botswana
1100.1486.2603 Boehringer Ingelheim Investigational Site
Gaborone, Botswana
1100.1486.1002 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1100.1486.1004 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
1100.1486.1013 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
1100.1486.1014 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1100.1486.1011 Boehringer Ingelheim Investigational Site
Quebec (Ste Foy), Quebec, Canada
1100.1486.3305A Boehringer Ingelheim Investigational Site
Angers, France
1100.1486.3305B Boehringer Ingelheim Investigational Site
Angers, France
1100.1486.3307A Boehringer Ingelheim Investigational Site
Bondy, France
1100.1486.3317A Boehringer Ingelheim Investigational Site
Bordeaux, France
1100.1486.3316A Boehringer Ingelheim Investigational Site
Brest, France
1100.1486.3316B Boehringer Ingelheim Investigational Site
Brest, France
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Caen, France
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Clamart, France
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Lyon, France
1100.1486.3308C Boehringer Ingelheim Investigational Site
Lyon, France
1100.1486.3301A Boehringer Ingelheim Investigational Site
Nantes, France
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Nantes, France
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Nantes, France
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Nantes, France
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Nantes, France
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Nantes, France
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Nantes, France
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Nantes, France
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Nantes, France
1100.1486.3306A Boehringer Ingelheim Investigational Site
Nice, France
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Paris, France
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Paris, France
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Paris, France
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Paris, France
1100.1486.3312A Boehringer Ingelheim Investigational Site
Paris, France
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Paris, France
1100.1486.3309A Boehringer Ingelheim Investigational Site
Saint-Etienne, France
1100.1486.3309B Boehringer Ingelheim Investigational Site
Saint-Etienne, France
1100.1486.3318A Boehringer Ingelheim Investigational Site
Toulon, France
1100.1486.3318B Boehringer Ingelheim Investigational Site
Toulon, France
1100.1486.3318C Boehringer Ingelheim Investigational Site
Toulon, France
1100.1486.3318D Boehringer Ingelheim Investigational Site
Toulon, France
1100.1486.3302A Boehringer Ingelheim Investigational Site
Toulouse, France
1100.1486.3302B Boehringer Ingelheim Investigational Site
Toulouse, France
1100.1486.3302C Boehringer Ingelheim Investigational Site
Toulouse, France
1100.1486.3310A Boehringer Ingelheim Investigational Site
Villeneuve-Saint-Georges, France
1100.1486.4902 Boehringer Ingelheim Investigational Site
Berlin, Germany
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Berlin, Germany
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Bochum, Germany
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Bonn, Germany
1100.1486.4907 Boehringer Ingelheim Investigational Site
Cologne, Germany
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Cologne, Germany
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Dortmund, Germany
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Düsseldorf, Germany
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Erlangen, Germany
1100.1486.4906 Boehringer Ingelheim Investigational Site
Essen, Germany
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Frankfurt, Germany
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Frankfurt am Main, Germany
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Frankfurt am Main, Germany
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Freiburg im Breisgau, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Hamburg, Germany
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Hamburg, Germany
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Hanover, Germany
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Hanover, Germany
1100.1486.4910 Boehringer Ingelheim Investigational Site
Kiel, Germany
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Mainz, Germany
1100.1486.4903 Boehringer Ingelheim Investigational Site
München, Germany
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München, Germany
1100.1486.4912 Boehringer Ingelheim Investigational Site
München, Germany
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Münster, Germany
1100.1486.4918 Boehringer Ingelheim Investigational Site
Osnabrück, Germany
1100.1486.4913 Boehringer Ingelheim Investigational Site
Ulm/Donau, Germany
1100.1486.4914 Boehringer Ingelheim Investigational Site
Würzburg, Germany
1100.1486.3531 Boehringer Ingelheim Investigational Site
Dublin, Ireland
1100.1486.3532 Boehringer Ingelheim Investigational Site
Dublin, Ireland
1100.1486.3908 Boehringer Ingelheim Investigational Site
Palermo, Italy
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Pescara, Italy
1100.1486.3901 Boehringer Ingelheim Investigational Site
Torino, Italy
1100.1486.3907 Boehringer Ingelheim Investigational Site
Treviso, Italy
1100.1486.3906 Boehringer Ingelheim Investigational Site
Verbania, Italy
1100.1486.5207 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1100.1486.5204 Boehringer Ingelheim Investigational Site
León, Mexico
1100.1486.3107 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1100.1486.3103 Boehringer Ingelheim Investigational Site
Arnhem, Netherlands
1100.1486.3101 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
1100.1486.3102 Boehringer Ingelheim Investigational Site
Zwolle, Netherlands
1100.1486.4803 Boehringer Ingelheim Investigational Site
Bydgoszcz, Poland
1100.1486.4801 Boehringer Ingelheim Investigational Site
Chorzów, Poland
1100.1486.4804 Boehringer Ingelheim Investigational Site
Warsaw, Poland
1100.1486.3503 Boehringer Ingelheim Investigational Site
Amadora, Portugal
1100.1486.3501 Boehringer Ingelheim Investigational Site
Lisbon, Portugal
1100.1486.3504 Boehringer Ingelheim Investigational Site
Lisbon, Portugal
1100.1486.0024 Boehringer Ingelheim Investigational Site
Ponce, Puerto Rico
1100.1486.0033 Boehringer Ingelheim Investigational Site
San Juan, Puerto Rico
1100.1486.4001 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1100.1486.4002 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1100.1486.7002 Boehringer Ingelheim Investigational Site
Moscow, Russia
1100.1486.7001 Boehringer Ingelheim Investigational Site
Saint Petersburg, Russia
1100.1486.2707 Boehringer Ingelheim Investigational Site
Bloemfontein, South Africa
1100.1486.2712 Boehringer Ingelheim Investigational Site
Bloemfontein, South Africa
1100.1486.2703 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1100.1486.2709 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1100.1486.2711 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1100.1486.2701 Boehringer Ingelheim Investigational Site
Edenvale, South Africa
1100.1486.2710 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1100.1486.2706 Boehringer Ingelheim Investigational Site
Mbombela, South Africa
1100.1486.2702 Boehringer Ingelheim Investigational Site
Port Elizabeth, South Africa
1100.1486.2704 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
1100.1486.3406 Boehringer Ingelheim Investigational Site
Alcalá de Henares (Madrid), Spain
1100.1486.3401 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3402 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3410 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3415 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3417 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3404 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat, Spain
1100.1486.3403 Boehringer Ingelheim Investigational Site
Madrid, Spain
1100.1486.3405 Boehringer Ingelheim Investigational Site
Madrid, Spain
1100.1486.3407 Boehringer Ingelheim Investigational Site
Madrid, Spain
1100.1486.3414 Boehringer Ingelheim Investigational Site
Madrid, Spain
1100.1486.3416 Boehringer Ingelheim Investigational Site
Mataró, Spain
1100.1486.3408 Boehringer Ingelheim Investigational Site
Valencia, Spain
1100.1486.4101 Boehringer Ingelheim Investigational Site
Basel, Switzerland
1100.1486.4109 Boehringer Ingelheim Investigational Site
Bern, Switzerland
1100.1486.4107 Boehringer Ingelheim Investigational Site
Geneva, Switzerland
1100.1486.4106 Boehringer Ingelheim Investigational Site
La Chaux-de-Fonds, Switzerland
1100.1486.4104 Boehringer Ingelheim Investigational Site
Lausanne, Switzerland
1100.1486.4102 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
1100.1486.4108 Boehringer Ingelheim Investigational Site
Sankt Gallen, Switzerland
1100.1486.4110 Boehringer Ingelheim Investigational Site
Zurich, Switzerland
1100.1486.4406 Boehringer Ingelheim Investigational Site
Birmingham, United Kingdom
1100.1486.4403 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1486.4404 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1486.4405 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1486.4407 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1486.4401 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1100.1486.4408 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1100.1486.4402 Boehringer Ingelheim Investigational Site
Plaistow, London, United Kingdom
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
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