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

NCT ID: NCT00389207

Last Updated: 2014-01-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NVP bid

nevirapine (NVP) 200 mg BID in combination with emtricitabine (FTC) and tenofovir DF (TDF)

Group Type ACTIVE_COMPARATOR

nevirapine bid

Intervention Type DRUG

nevirapine twice daily

NVP qd

nevirapine (NVP) 400 mg QD in combination with emtricitabine (FTC) and tenofovir DF (TDF)

Group Type EXPERIMENTAL

nevirapine qd

Intervention Type DRUG

nevirapine once daily

ATZ/r

ritonavir-boosted atazanavir in combination with emtricitabine (FTC) and tenofovir DF (TDF)

Group Type ACTIVE_COMPARATOR

atazanavir

Intervention Type DRUG

atazanavir once daily

Interventions

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nevirapine bid

nevirapine twice daily

Intervention Type DRUG

nevirapine qd

nevirapine once daily

Intervention Type DRUG

atazanavir

atazanavir once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
2. HIV-1-infected males or females \>= 18 years of age with positive serology confirmed by Western 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 \< 250 cells/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) \>= 50 ml/min according to the Cockcroft-Gault formula
7. Karnofsky score \>= 70
8. Acceptable medical history, as assessed by the investigator

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 to use methods of contraception other than ethinyl estradiol containing oral contraceptives
4. Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) \> grade 2 (triglycerides \> DAIDS grade 3; total cholesterol no restrictions)
5. Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-Ribo Nucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) \> 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1)
6. Hypersensitivity to any ingredients of the test products
7. Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected to receive these during the study
8. Patients who are receiving other concomitant treatments which are not permitted
9. Use of other investigational medications within 30 days before study entry or during the trial
10. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone)
11. Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
12. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
13. Patients who are receiving systemic treatment for malignant disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1100.1470.54004 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1100.1470.54002 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

Site Status

1100.1470.54003 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

Site Status

1100.1470.54001 Boehringer Ingelheim Investigational Site

Rosario, , Argentina

Site Status

1100.1470.49001 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1100.1470.49002 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1100.1470.49003 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

1100.1470.49018 Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

1100.1470.49014 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1100.1470.49008 Boehringer Ingelheim Investigational Site

Erlangen, , Germany

Site Status

1100.1470.49035 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1100.1470.49036 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Site Status

1100.1470.49033 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, , Germany

Site Status

1100.1470.49016 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1100.1470.49031 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1100.1470.49037 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1100.1470.49020 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1100.1470.49038 Boehringer Ingelheim Investigational Site

Magdeburg, , Germany

Site Status

1100.1470.49034 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1100.1470.49000 Boehringer Ingelheim Investigational Site

Ulm, , Germany

Site Status

1100.1470.49032 Boehringer Ingelheim Investigational Site

Würzburg, , Germany

Site Status

1100.1470.39001 Boehringer Ingelheim Investigational Site

Bergamo, , Italy

Site Status

1100.1470.39003 Boehringer Ingelheim Investigational Site

Bologna, , Italy

Site Status

1100.1470.39012 Ospedale Sant'Anna

Como, , Italy

Site Status

1100.1470.39006 Boehringer Ingelheim Investigational Site

Ferrara, , Italy

Site Status

1100.1470.39010 Boehringer Ingelheim Investigational Site

Lecco, , Italy

Site Status

1100.1470.39004 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

1100.1470.39009 Boehringer Ingelheim Investigational Site

Torrette Di Ancona, , Italy

Site Status

1100.1470.39007 Boehringer Ingelheim Investigational Site

Varese, , Italy

Site Status

1100.1470.55006 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

Site Status

1100.1470.55004 Boehringer Ingelheim Investigational Site

Col Obregón, , Mexico

Site Status

1100.1470.55008 Boehringer Ingelheim Investigational Site

Col. Los Filtros, San Luis Potosí, , Mexico

Site Status

1100.1470.55001 Boehringer Ingelheim Investigational Site

Col. Toriello Guerra, , Mexico

Site Status

1100.1470.55007 Boehringer Ingelheim Investigational Site

Guadalajara Jal., , Mexico

Site Status

1100.1470.55003 Boehringer Ingelheim Investigational Site

Tlalpan-México D,F, , Mexico

Site Status

1100.1470.48003 Boehringer Ingelheim Investigational Site

Bydgoszcz, , Poland

Site Status

1100.1470.48001 Boehringer Ingelheim Investigational Site

Chorzów, , Poland

Site Status

1100.1470.48002 Boehringer Ingelheim Investigational Site

Szczecin, , Poland

Site Status

1100.1470.48004 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1100.1470.35102 Boehringer Ingelheim Investigational Site

Cascais, , Portugal

Site Status

1100.1470.35101 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1100.1470.35103 Boehringer Ingelheim Investigational Site

Porto, , Portugal

Site Status

1100.1470.40001 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1100.1470.40002 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1100.1470.34013 Boehringer Ingelheim Investigational Site

Alcalá de Henares (Madrid), , Spain

Site Status

1100.1470.34008 Boehringer Ingelheim Investigational Site

Badalona, , Spain

Site Status

1100.1470.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1100.1470.34003 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1100.1470.34004 Boehringer Ingelheim Investigational Site

Donostia / San Sebastian, , Spain

Site Status

1100.1470.34009 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status

1100.1470.34010 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1100.1470.34012 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1100.1470.34014 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1100.1470.34015 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1100.1470.34019 Boehringer Ingelheim Investigational Site

Málaga, , Spain

Site Status

1100.1470.34007 Boehringer Ingelheim Investigational Site

Sabadell (Barcelona), , Spain

Site Status

1100.1470.34006 Boehringer Ingelheim Investigational Site

Santa Cruz de Tenerife, , Spain

Site Status

1100.1470.34011 Boehringer Ingelheim Investigational Site

Vigo, , Spain

Site Status

1100.1470.41004 Boehringer Ingelheim Investigational Site

Bern, , Switzerland

Site Status

1100.1470.41001 Boehringer Ingelheim Investigational Site

Lugano, , Switzerland

Site Status

1100.1470.41003 Boehringer Ingelheim Investigational Site

Sankt Gallen, , Switzerland

Site Status

1100.1470.41002 Boehringer Ingelheim Investigational Site

Zurich, , Switzerland

Site Status

1100.1470.44004 Boehringer Ingelheim Investigational Site

Birmingham, , United Kingdom

Site Status

1100.1470.44001 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1100.1470.44002 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1100.1470.44005 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1100.1470.44006 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1100.1470.44003 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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Argentina Germany Italy Mexico Poland Portugal Romania Spain Switzerland United Kingdom

References

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Seclen E, Soriano V, Gonzalez MM, Martin-Carbonero L, Gellermann H, Distel M, Kadus W, Poveda E. Impact of baseline HIV-1 tropism on viral response and CD4 cell count gains in HIV-infected patients receiving first-line antiretroviral therapy. J Infect Dis. 2011 Jul 1;204(1):139-44. doi: 10.1093/infdis/jir218.

Reference Type DERIVED
PMID: 21628668 (View on PubMed)

Soriano V, Arasteh K, Migrone H, Lutz T, Opravil M, Andrade-Villanueva J, Antunes F, Di Perri G, Podzamczer D, Taylor S, Domingo P, Gellermann H, de Rossi L; ARTEN investigators. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir Ther. 2011;16(3):339-48. doi: 10.3851/IMP1745.

Reference Type DERIVED
PMID: 21555816 (View on PubMed)

Other Identifiers

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2005-004330-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1100.1470

Identifier Type: -

Identifier Source: org_study_id

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