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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: nevirapine bid (Drug); nevirapine qd (Drug); atazanavir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

Official title: Randomized, Open Label Study Evaluating the Lipid Profile Difference and Efficacy of a Combined Therapy Including Tenofovir, Emtricitabine + Atazanavir / r or NVP in Naive HIV - 1 Infected Patients.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Treatment Response at Week 48

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria: 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: 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

Locations and Contacts

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

Additional Information

Starting date: October 2006
Last updated: December 9, 2013

Page last updated: August 23, 2015

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