VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

March 7, 2014 updated by: Boehringer Ingelheim

A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1068

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal, Argentina
        • 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
      • Mar del Plata, Argentina
        • 1100.1486.5403 Boehringer Ingelheim Investigational Site
      • Quilmes, Argentina
        • 1100.1486.5409 Boehringer Ingelheim Investigational Site
      • Rosario, Argentina
        • 1100.1486.5405 Boehringer Ingelheim Investigational Site
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia
        • 1100.1486.6101 Boehringer Ingelheim Investigational Site
      • Darlinghurst, New South Wales, Australia
        • 1100.1486.6102 Boehringer Ingelheim Investigational Site
      • Surry Hills, New South Wales, Australia
        • 1100.1486.6104 Boehringer Ingelheim Investigational Site
    • Queensland
      • Brisbane, Queensland, Australia
        • 1100.1486.6103 Boehringer Ingelheim Investigational Site
  • Belgium
      • Brugge, Belgium
        • 1100.1486.3208 Boehringer Ingelheim Investigational Site
      • Brussel, Belgium
        • 1100.1486.3207 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgium
        • 1100.1486.3201 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgium
        • 1100.1486.3203 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgium
        • 1100.1486.3205 Boehringer Ingelheim Investigational Site
      • Charleroi, Belgium
        • 1100.1486.3209 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 1100.1486.3202 Boehringer Ingelheim Investigational Site
      • Liège, Belgium
        • 1100.1486.3204 Boehringer Ingelheim Investigational Site
      • Liège, Belgium
        • 1100.1486.3206 Boehringer Ingelheim Investigational Site
  • Botswana
      • Francistown, Botswana
        • 1100.1486.2605 Boehringer Ingelheim Investigational Site
      • Gaborone, Botswana
        • 1100.1486.2601 Boehringer Ingelheim Investigational Site
      • Gaborone, Botswana
        • 1100.1486.2603 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1100.1486.1002 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1100.1486.1004 Boehringer Ingelheim Investigational Site
    • Ontario
      • Toronto, Ontario, Canada
        • 1100.1486.1013 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1100.1486.1016 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 1100.1486.1005 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1100.1486.1010 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1100.1486.1014 Boehringer Ingelheim Investigational Site
      • Quebec (Ste Foy), Quebec, Canada
        • 1100.1486.1011 Boehringer Ingelheim Investigational Site
  • France
      • Angers, France
        • 1100.1486.3305A Boehringer Ingelheim Investigational Site
      • Angers, France
        • 1100.1486.3305B Boehringer Ingelheim Investigational Site
      • Bondy, France
        • 1100.1486.3307A Boehringer Ingelheim Investigational Site
      • Bordeaux Cedex, France
        • 1100.1486.3317A Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1100.1486.3316A Boehringer Ingelheim Investigational Site
      • Brest Cedex, France
        • 1100.1486.3316B Boehringer Ingelheim Investigational Site
      • Caen cedex 5, France
        • 1100.1486.3314E Boehringer Ingelheim Investigational Site
      • Clamart, France
        • 1100.1486.3304A Boehringer Ingelheim Investigational Site
      • Lyon Cedex 3, France
        • 1100.1486.3308A Boehringer Ingelheim Investigational Site
      • Lyon Cedex 3, France
        • 1100.1486.3308C Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301A Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301B Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301C Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301D Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301E Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301F Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301G Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301H Boehringer Ingelheim Investigational Site
      • Nantes, France
        • 1100.1486.3301I Boehringer Ingelheim Investigational Site
      • Nice cedex 3, France
        • 1100.1486.3306A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1100.1486.3303A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1100.1486.3303B Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1100.1486.3303C Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1100.1486.3303D Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1100.1486.3312A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1100.1486.3312B Boehringer Ingelheim Investigational Site
      • Saint Etienne, France
        • 1100.1486.3309A Boehringer Ingelheim Investigational Site
      • Saint Etienne, France
        • 1100.1486.3309B Boehringer Ingelheim Investigational Site
      • Toulon cedex, France
        • 1100.1486.3318A Boehringer Ingelheim Investigational Site
      • Toulon cedex, France
        • 1100.1486.3318B Boehringer Ingelheim Investigational Site
      • Toulon cedex, France
        • 1100.1486.3318C Boehringer Ingelheim Investigational Site
      • Toulon cedex, France
        • 1100.1486.3318D Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9, France
        • 1100.1486.3302A Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9, France
        • 1100.1486.3302B Boehringer Ingelheim Investigational Site
      • Toulouse cedex 9, France
        • 1100.1486.3302C Boehringer Ingelheim Investigational Site
      • Villeneuve St Georges cedex, France
        • 1100.1486.3310A Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 1100.1486.4902 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1100.1486.4928 Boehringer Ingelheim Investigational Site
      • Bochum, Germany
        • 1100.1486.4932 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 1100.1486.4922 Boehringer Ingelheim Investigational Site
      • Dortmund, Germany
        • 1100.1486.4911 Boehringer Ingelheim Investigational Site
      • Düsseldorf, Germany
        • 1100.1486.4919 Boehringer Ingelheim Investigational Site
      • Erlangen, Germany
        • 1100.1486.4908 Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • 1100.1486.4906 Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • 1100.1486.4926 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germany
        • 1100.1486.4916 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germany
        • 1100.1486.4929 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 1100.1486.4901 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 1100.1486.4930 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1100.1486.4909 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1100.1486.4920 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1100.1486.4925 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1100.1486.4915 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1100.1486.4923 Boehringer Ingelheim Investigational Site
      • Kiel, Germany
        • 1100.1486.4910 Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • 1100.1486.4907 Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • 1100.1486.4924 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1100.1486.4927 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1100.1486.4903 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1100.1486.4904 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1100.1486.4912 Boehringer Ingelheim Investigational Site
      • Münster, Germany
        • 1100.1486.4905 Boehringer Ingelheim Investigational Site
      • Osnabrück, Germany
        • 1100.1486.4918 Boehringer Ingelheim Investigational Site
      • Ulm/Donau, Germany
        • 1100.1486.4913 Boehringer Ingelheim Investigational Site
      • Würzburg, Germany
        • 1100.1486.4914 Boehringer Ingelheim Investigational Site
  • Ireland
      • Dublin, Ireland
        • 1100.1486.3532 Boehringer Ingelheim Investigational Site
      • Dublin 8, Ireland
        • 1100.1486.3531 Boehringer Ingelheim Investigational Site
  • Italy
      • Palermo, Italy
        • 1100.1486.3908 Boehringer Ingelheim Investigational Site
      • Pescara, Italy
        • 1100.1486.3905 Boehringer Ingelheim Investigational Site
      • Torino, Italy
        • 1100.1486.3901 Boehringer Ingelheim Investigational Site
      • Treviso, Italy
        • 1100.1486.3907 Boehringer Ingelheim Investigational Site
      • Verbania, Italy
        • 1100.1486.3906 Boehringer Ingelheim Investigational Site
  • Mexico
      • Guadalajara, Mexico
        • 1100.1486.5207 Boehringer Ingelheim Investigational Site
      • León, Mexico
        • 1100.1486.5204 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Amsterdam, Netherlands
        • 1100.1486.3107 Boehringer Ingelheim Investigational Site
      • Arnhem, Netherlands
        • 1100.1486.3103 Boehringer Ingelheim Investigational Site
      • Rotterdam, Netherlands
        • 1100.1486.3101 Boehringer Ingelheim Investigational Site
      • Zwolle, Netherlands
        • 1100.1486.3102 Boehringer Ingelheim Investigational Site
  • Poland
      • Bydgoszcz, Poland
        • 1100.1486.4803 Boehringer Ingelheim Investigational Site
      • Chorzow, Poland
        • 1100.1486.4801 Boehringer Ingelheim Investigational Site
      • Warsaw, Poland
        • 1100.1486.4804 Boehringer Ingelheim Investigational Site
  • Portugal
      • Amadora, Portugal
        • 1100.1486.3503 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1100.1486.3501 Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • 1100.1486.3504 Boehringer Ingelheim Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico
        • 1100.1486.0024 Boehringer Ingelheim Investigational Site
      • San Juan, Puerto Rico
        • 1100.1486.0033 Boehringer Ingelheim Investigational Site
  • Romania
      • Bucharest, Romania
        • 1100.1486.4001 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 1100.1486.4002 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1100.1486.7002 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1100.1486.7001 Boehringer Ingelheim Investigational Site
  • South Africa
      • Bloemfontein, South Africa
        • 1100.1486.2707 Boehringer Ingelheim Investigational Site
      • Bloemfontein, South Africa
        • 1100.1486.2712 Boehringer Ingelheim Investigational Site
      • Cape Town, 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
      • Edenvale, South Africa
        • 1100.1486.2701 Boehringer Ingelheim Investigational Site
      • Johannesburg, South Africa
        • 1100.1486.2710 Boehringer Ingelheim Investigational Site
      • Nelspruit, South Africa
        • 1100.1486.2706 Boehringer Ingelheim Investigational Site
      • Port Elizabeth, South Africa
        • 1100.1486.2702 Boehringer Ingelheim Investigational Site
      • Pretoria, South Africa
        • 1100.1486.2704 Boehringer Ingelheim Investigational Site
  • Spain
      • Alcalá de Henares (Madrid), Spain
        • 1100.1486.3406 Boehringer Ingelheim Investigational Site
      • Barcelona, 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
      • L'Hospitalet de Llobregat, Spain
        • 1100.1486.3404 Boehringer Ingelheim Investigational Site
      • Madrid, 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
      • Mataro, Spain
        • 1100.1486.3416 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1100.1486.3408 Boehringer Ingelheim Investigational Site
  • Switzerland
      • Basel, Switzerland
        • 1100.1486.4101 Boehringer Ingelheim Investigational Site
      • Bern, Switzerland
        • 1100.1486.4109 Boehringer Ingelheim Investigational Site
      • Genève, Switzerland
        • 1100.1486.4107 Boehringer Ingelheim Investigational Site
      • La Chaux-de-Fonds, Switzerland
        • 1100.1486.4106 Boehringer Ingelheim Investigational Site
      • Lausanne, Switzerland
        • 1100.1486.4104 Boehringer Ingelheim Investigational Site
      • Lugano, Switzerland
        • 1100.1486.4102 Boehringer Ingelheim Investigational Site
      • St. Gallen, Switzerland
        • 1100.1486.4108 Boehringer Ingelheim Investigational Site
      • Zürich, Switzerland
        • 1100.1486.4110 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom
        • 1100.1486.4406 Boehringer Ingelheim Investigational Site
      • London, 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
      • Manchester, United Kingdom
        • 1100.1486.4401 Boehringer Ingelheim Investigational Site
      • Manchester, United Kingdom
        • 1100.1486.4408 Boehringer Ingelheim Investigational Site
      • Plaistow, London, United Kingdom
        • 1100.1486.4402 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1100.1486.0040 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • 1100.1486.0013 Boehringer Ingelheim Investigational Site
    • California
      • Bakersfield, California, United States
        • 1100.1486.0017 Boehringer Ingelheim Investigational Site
      • Beverly Hills, California, United States
        • 1100.1486.0001 Boehringer Ingelheim Investigational Site
      • Beverly Hills, California, United States
        • 1100.1486.0057 Boehringer Ingelheim Investigational Site
      • Beverly Hills, California, United States
        • 1100.1486.0059 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1100.1486.0035 Boehringer Ingelheim Investigational Site
      • Los Angeles, 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
        • 1100.1486.0041 Boehringer Ingelheim Investigational Site
      • Sacramento, California, United States
        • 1100.1486.0032 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 1100.1486.0028 Boehringer Ingelheim Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • 1100.1486.0023 Boehringer Ingelheim Investigational Site
      • Washington, District of Columbia, United States
        • 1100.1486.0029 Boehringer Ingelheim Investigational Site
      • Washington, District of Columbia, United States
        • 1100.1486.0048 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, United States
        • 1100.1486.0037 Boehringer Ingelheim Investigational Site
      • Fort Lauderdale, Florida, United States
        • 1100.1486.0043 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1100.1486.0012 Boehringer Ingelheim Investigational Site
      • Miami Beach, Florida, United States
        • 1100.1486.0007 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 1100.1486.0039 Boehringer Ingelheim Investigational Site
      • Vero Beach, Florida, United States
        • 1100.1486.0050 Boehringer Ingelheim Investigational Site
      • Wilton Manors, Florida, United States
        • 1100.1486.0014 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 1100.1486.0031 Boehringer Ingelheim Investigational Site
      • Macon, Georgia, United States
        • 1100.1486.0010 Boehringer Ingelheim Investigational Site
    • Idaho
      • Boise, Idaho, United States
        • 1100.1486.0053 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1100.1486.0002 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 1100.1486.0026 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • 1100.1486.0020 Boehringer Ingelheim Investigational Site
    • Michigan
      • Berkley, Michigan, United States
        • 1100.1486.0019 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City, Missouri, United States
        • 1100.1486.0006 Boehringer Ingelheim Investigational Site
      • St. Louis, Missouri, United States
        • 1100.1486.0027 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • 1100.1486.0055 Boehringer Ingelheim Investigational Site
      • Huntersville, North Carolina, United States
        • 1100.1486.0003 Boehringer Ingelheim Investigational Site
    • Ohio
      • Akron, Ohio, United States
        • 1100.1486.0005 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, United States
        • 1100.1486.0004 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1100.1486.0018 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1100.1486.0038 Boehringer Ingelheim Investigational Site
      • Fort Worth, Texas, United States
        • 1100.1486.0044 Boehringer Ingelheim Investigational Site
      • Harlingen, Texas, United States
        • 1100.1486.0054 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1100.1486.0009 Boehringer Ingelheim Investigational Site
    • Virginia
      • Annandale, Virginia, United States
        • 1100.1486.0046 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nevirapine XR
400 mg QD
Drug: nevirapine XR
400 mg QD
Active Comparator: nevirapine IR
200 mg BID
Drug: nevirapine IR
200 mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time Frame: week 48
Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL
week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time Frame: week 0 to 144
week 0 to 144
Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Time Frame: week 144
Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL
week 144
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Time Frame: week 0 to 144
week 0 to 144
Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
Time Frame: baseline, week 144
baseline, week 144
Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
Time Frame: baseline, week 144
baseline, week 144
Occurrence of Rashes
Time Frame: until last patient completed 144 weeks (up to 193 weeks)
Frequency of patients with drug related rash events by functional grouping
until last patient completed 144 weeks (up to 193 weeks)
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
Time Frame: until last patient completed 144 weeks (up to 193 weeks)
until last patient completed 144 weeks (up to 193 weeks)
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Time Frame: week 0 to 144
week 0 to 144
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Time Frame: week 0 to 72
week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Time Frame: week 0 to 72
week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Time Frame: week 0 to 72
week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Time Frame: week 0 to 72
week 0 to 72
Relative Bioavailability Trough C_pre,ss,1
Time Frame: week 132
Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.
week 132
Occurrence of Hepatic Events
Time Frame: until last patient completed 144 weeks (up to 193 weeks)
Frequency of patients with hepatitis symptoms
until last patient completed 144 weeks (up to 193 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1100.1486
  • 2007-003654-29 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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