Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

Last updated: December 9, 2013
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Hiv/aids

Aids And Aids Related Infections

Treatment

N/A

Clinical Study ID

NCT00389207
1100.1470
2005-004330-40
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria: Inclusion Criteria:

  1. Signed informed consent in accordance with Good Clinical Practice (GCP) and localregulatory requirements prior to trial participation

  2. HIV-1-infected males or females >= 18 years of age with positive serology confirmed byWestern blot

  3. No previous antiretroviral treatment (of more than 7 days)

  4. Males with CD4+ counts of < 400 cells/mm3 and females with CD4+ counts of < 250cells/mm3

  5. NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report

  6. Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50ml/min according to the Cockcroft-Gault formula

  7. Karnofsky score >= 70

  8. Acceptable medical history, as assessed by the investigator

Exclusion

Exclusion criteria: Exclusion Criteria:

  1. Active drug abuse or chronic alcoholism at the investigator's discretion

  2. Hepatic cirrhosis stage Child-Pugh B or C

  3. Female patients of child-bearing potential who:

  • have a positive serum pregnancy test at screening or during the study,

  • are breast feeding,

  • are planning to become pregnant,

  • are not willing to use a barrier method of contraception, or are not willing touse methods of contraception other than ethinyl estradiol containing oralcontraceptives

  1. Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) > grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions)

  2. Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-RiboNucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) > 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1)

  3. Hypersensitivity to any ingredients of the test products

  4. Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B,vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) orpotential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir,ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatorydrugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected toreceive these during the study

  5. Patients who are receiving other concomitant treatments which are not permitted

  6. Use of other investigational medications within 30 days before study entry or duringthe trial

  7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment withprednisone)

  8. Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi'sSarcoma (KS), and/or any lymphoma

  9. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatmentfor at least 12 weeks at screening visit

  10. Patients who are receiving systemic treatment for malignant disease

Study Design

Total Participants: 576
Study Start date:
October 01, 2006
Estimated Completion Date:

Connect with a study center

  • 1100.1470.54004 Boehringer Ingelheim Investigational Site

    Capital Federal,
    Argentina

    Site Not Available

  • 1100.1470.54002 Boehringer Ingelheim Investigational Site

    Córdoba,
    Argentina

    Site Not Available

  • 1100.1470.54002 Boehringer Ingelheim Investigational Site

    Córdoba,
    Argentina

    Site Not Available

  • 1100.1470.54003 Boehringer Ingelheim Investigational Site

    Mar del Plata,
    Argentina

    Site Not Available

  • 1100.1470.54001 Boehringer Ingelheim Investigational Site

    Rosario,
    Argentina

    Site Not Available

  • 1100.1470.49001 Boehringer Ingelheim Investigational Site

    Berlin,
    Germany

    Site Not Available

  • 1100.1470.49002 Boehringer Ingelheim Investigational Site

    Berlin,
    Germany

    Site Not Available

  • 1100.1470.49003 Boehringer Ingelheim Investigational Site

    Bochum,
    Germany

    Site Not Available

  • 1100.1470.49018 Boehringer Ingelheim Investigational Site

    Bonn,
    Germany

    Site Not Available

  • 1100.1470.49014 Boehringer Ingelheim Investigational Site

    Düsseldorf,
    Germany

    Site Not Available

  • 1100.1470.49014 Boehringer Ingelheim Investigational Site

    Düsseldorf,
    Germany

    Site Not Available

  • 1100.1470.49008 Boehringer Ingelheim Investigational Site

    Erlangen,
    Germany

    Site Not Available

  • 1100.1470.49035 Boehringer Ingelheim Investigational Site

    Frankfurt,
    Germany

    Site Not Available

  • 1100.1470.49036 Boehringer Ingelheim Investigational Site

    Frankfurt am Main,
    Germany

    Site Not Available

  • 1100.1470.49033 Boehringer Ingelheim Investigational Site

    Freiburg/Breisgau,
    Germany

    Site Not Available

  • 1100.1470.49016 Boehringer Ingelheim Investigational Site

    Hamburg,
    Germany

    Site Not Available

  • 1100.1470.49031 Boehringer Ingelheim Investigational Site

    Hamburg,
    Germany

    Site Not Available

  • 1100.1470.49037 Boehringer Ingelheim Investigational Site

    Hamburg,
    Germany

    Site Not Available

  • 1100.1470.49020 Boehringer Ingelheim Investigational Site

    Hannover,
    Germany

    Site Not Available

  • 1100.1470.49038 Boehringer Ingelheim Investigational Site

    Magdeburg,
    Germany

    Site Not Available

  • 1100.1470.49034 Boehringer Ingelheim Investigational Site

    München,
    Germany

    Site Not Available

  • 1100.1470.49034 Boehringer Ingelheim Investigational Site

    München,
    Germany

    Site Not Available

  • 1100.1470.49000 Boehringer Ingelheim Investigational Site

    Ulm,
    Germany

    Site Not Available

  • 1100.1470.49032 Boehringer Ingelheim Investigational Site

    Würzburg,
    Germany

    Site Not Available

  • 1100.1470.49032 Boehringer Ingelheim Investigational Site

    Würzburg,
    Germany

    Site Not Available

  • 1100.1470.39001 Boehringer Ingelheim Investigational Site

    Bergamo,
    Italy

    Site Not Available

  • 1100.1470.39003 Boehringer Ingelheim Investigational Site

    Bologna,
    Italy

    Site Not Available

  • 1100.1470.39012 Ospedale Sant'Anna

    Como,
    Italy

    Site Not Available

  • 1100.1470.39006 Boehringer Ingelheim Investigational Site

    Ferrara,
    Italy

    Site Not Available

  • 1100.1470.39010 Boehringer Ingelheim Investigational Site

    Lecco,
    Italy

    Site Not Available

  • 1100.1470.39004 Boehringer Ingelheim Investigational Site

    Torino,
    Italy

    Site Not Available

  • 1100.1470.39009 Boehringer Ingelheim Investigational Site

    Torrette Di Ancona,
    Italy

    Site Not Available

  • 1100.1470.39007 Boehringer Ingelheim Investigational Site

    Varese,
    Italy

    Site Not Available

  • 1100.1470.55006 Boehringer Ingelheim Investigational Site

    Aguascalientes,
    Mexico

    Site Not Available

  • 1100.1470.55004 Boehringer Ingelheim Investigational Site

    Col Obregón,
    Mexico

    Site Not Available

  • 1100.1470.55004 Boehringer Ingelheim Investigational Site

    Col Obregón,
    Mexico

    Site Not Available

  • 1100.1470.55008 Boehringer Ingelheim Investigational Site

    Col. Los Filtros, San Luis Potosí,
    Mexico

    Site Not Available

  • 1100.1470.55008 Boehringer Ingelheim Investigational Site

    Col. Los Filtros, San Luis Potosí,
    Mexico

    Site Not Available

  • 1100.1470.55001 Boehringer Ingelheim Investigational Site

    Col. Toriello Guerra,
    Mexico

    Site Not Available

  • 1100.1470.55007 Boehringer Ingelheim Investigational Site

    Guadalajara Jal.,
    Mexico

    Site Not Available

  • 1100.1470.55003 Boehringer Ingelheim Investigational Site

    Tlalpan-México D,F,
    Mexico

    Site Not Available

  • 1100.1470.55003 Boehringer Ingelheim Investigational Site

    Tlalpan-México D,F,
    Mexico

    Site Not Available

  • 1100.1470.48003 Boehringer Ingelheim Investigational Site

    Bydgoszcz,
    Poland

    Site Not Available

  • 1100.1470.48001 Boehringer Ingelheim Investigational Site

    Chorzow,
    Poland

    Site Not Available

  • 1100.1470.48002 Boehringer Ingelheim Investigational Site

    Szczecin,
    Poland

    Site Not Available

  • 1100.1470.48004 Boehringer Ingelheim Investigational Site

    Warsaw,
    Poland

    Site Not Available

  • 1100.1470.35102 Boehringer Ingelheim Investigational Site

    Cascais,
    Portugal

    Site Not Available

  • 1100.1470.35101 Boehringer Ingelheim Investigational Site

    Lisboa,
    Portugal

    Site Not Available

  • 1100.1470.35103 Boehringer Ingelheim Investigational Site

    Porto,
    Portugal

    Site Not Available

  • 1100.1470.40001 Boehringer Ingelheim Investigational Site

    Bucharest,
    Romania

    Site Not Available

  • 1100.1470.40002 Boehringer Ingelheim Investigational Site

    Bucharest,
    Romania

    Site Not Available

  • 1100.1470.34013 Boehringer Ingelheim Investigational Site

    Alcalá de Henares (Madrid),
    Spain

    Site Not Available

  • 1100.1470.34013 Boehringer Ingelheim Investigational Site

    Alcalá de Henares (Madrid),
    Spain

    Site Not Available

  • 1100.1470.34008 Boehringer Ingelheim Investigational Site

    Badalona,
    Spain

    Site Not Available

  • 1100.1470.34002 Boehringer Ingelheim Investigational Site

    Barcelona,
    Spain

    Site Not Available

  • 1100.1470.34003 Boehringer Ingelheim Investigational Site

    Barcelona,
    Spain

    Site Not Available

  • 1100.1470.34009 Boehringer Ingelheim Investigational Site

    L'Hospitalet de Llobregat,
    Spain

    Site Not Available

  • 1100.1470.34010 Boehringer Ingelheim Investigational Site

    Madrid,
    Spain

    Site Not Available

  • 1100.1470.34012 Boehringer Ingelheim Investigational Site

    Madrid,
    Spain

    Site Not Available

  • 1100.1470.34014 Boehringer Ingelheim Investigational Site

    Madrid,
    Spain

    Site Not Available

  • 1100.1470.34015 Boehringer Ingelheim Investigational Site

    Madrid,
    Spain

    Site Not Available

  • 1100.1470.34019 Boehringer Ingelheim Investigational Site

    Malaga,
    Spain

    Site Not Available

  • 1100.1470.34007 Boehringer Ingelheim Investigational Site

    Sabadell (Barcelona),
    Spain

    Site Not Available

  • 1100.1470.34004 Boehringer Ingelheim Investigational Site

    San Sebastian,
    Spain

    Site Not Available

  • 1100.1470.34006 Boehringer Ingelheim Investigational Site

    Santa Cruz de Tenerife,
    Spain

    Site Not Available

  • 1100.1470.34011 Boehringer Ingelheim Investigational Site

    Vigo,
    Spain

    Site Not Available

  • 1100.1470.41004 Boehringer Ingelheim Investigational Site

    Bern,
    Switzerland

    Site Not Available

  • 1100.1470.41001 Boehringer Ingelheim Investigational Site

    Lugano,
    Switzerland

    Site Not Available

  • 1100.1470.41003 Boehringer Ingelheim Investigational Site

    St. Gallen,
    Switzerland

    Site Not Available

  • 1100.1470.41002 Boehringer Ingelheim Investigational Site

    Zürich,
    Switzerland

    Site Not Available

  • 1100.1470.41002 Boehringer Ingelheim Investigational Site

    Zürich,
    Switzerland

    Site Not Available

  • 1100.1470.44004 Boehringer Ingelheim Investigational Site

    Birmingham,
    United Kingdom

    Site Not Available

  • 1100.1470.44001 Boehringer Ingelheim Investigational Site

    London,
    United Kingdom

    Site Not Available

  • 1100.1470.44002 Boehringer Ingelheim Investigational Site

    London,
    United Kingdom

    Site Not Available

  • 1100.1470.44005 Boehringer Ingelheim Investigational Site

    London,
    United Kingdom

    Site Not Available

  • 1100.1470.44006 Boehringer Ingelheim Investigational Site

    London,
    United Kingdom

    Site Not Available

  • 1100.1470.44003 Boehringer Ingelheim Investigational Site

    Manchester,
    United Kingdom

    Site Not Available

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