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Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir DF in HIV-1-Infected Treatment Naive Adults

This study is ongoing, but not recruiting participants.

Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00389207
  Purpose

Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Vir amune) dosing regimens (once daily and twice daily application) and of atazanavir/ritonavir (Reyataz

/Norvir), all on an emtricitabine/tenofovir DF (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg twice daily, or NVP 400 mg once daily, or riton avir-boosted atazanavir (ATZ/r), all in combination with emtricitabine (FTC) and tenofovir DF (TDF).

All patients receiving NVP will start at 200 mg QD for 2 weeks, because it has been demonstrated th at this lead-in dosing regimen reduces the frequency of NVP-induced rash. At Visit 3 (Week 2), patie nts increase the NVP dose to either 200 mg BID or to 400 mg QD. Patients receiving ATZ/r will be tre ated with ATZ 300 mg once daily, boosted by 100 mg ritonavir (RTV) once daily. Background antiretrov iral therapy for all patients consists of one tablet of Truvada. Treatment duration is 48 weeks (pri mary endpoint) with an extension to 144 weeks. Patients may also participate in the metabolic sub-st udy, comparing NVP and ATZ/r for signs and symptoms of lypodystrophy and serum lipid/glycaemic abnor malities.


Condition Intervention Phase
HIV Infections
Drug: Atazanavir/Ritonavir
Drug: Emtricitabine/Tenofovir DF
Drug: Nevirapine
Phase III

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Ritonavir    Nevirapine    Atazanavir sulfate    BMS 232632    Tenofovir    Tenofovir disoproxil    Tenofovir Disoproxil Fumarate    Lipids   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Antiretroviral effect at the 48th week [ Time Frame: Antiretroviral effect at the 48th week ]

Secondary Outcome Measures:
  • Changes in blood lipid levels over time. Change in the estimated cardiovascular risk using the Framingham algorithm. Change in quality of life . Cost-effectiveness of each treatment regimen. [ Time Frame: until week 144 ]

Estimated Enrollment:   561
Study Start Date:   October 2006
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Atazanavir/Ritonavir
    300mg Atazanavir/100mg Ritonavir/day
    Drug: Emtricitabine/Tenofovir DF
    1 Tablet/day
    Drug: Nevirapine
    400mg/day
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Inclusion Criteria:

  1. Signed informed consent in accordance with GCP and local regulatory requireme nts prior to trial participation
  2. HIV-1-infected males or females >= 18 years of age with positive serology (EL ISA) 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 < 2 50 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 co ntraceptives
  4. Laboratory parameters > DAIDS grade 2 (triglycerides > DAIDS grade 3 total cholesterol no restrictions)
  5. Active hepatitis B or C disease, defined as HBsAg-positive or HCV-RNA- positi ve with AST/ALT > 2.5x ULN (DAIDS grade 1)
  6. Hypersensitivity to any ingredients of the test products
  7. Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, v ancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporin e) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, vala cyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti- inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening o r are expected to receive these during the study
  8. Patients who are receiving other concomitant treatments which are not permitt ed
  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 th e trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic trea tment with prednisone)
  11. Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kapo si's Sarcoma (KS), and/or any lymphoma
  12. Any AIDS defining illness that is unresolved, symptomatic or not stable on t reatment for at least 12 weeks at screening visit
  13. Patients who are receiving systemic treatment for malignant disease
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389207

Show 59 study locations  Show 59 Study Locations

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals

Investigators
Study Chair:     Boehringer Ingelheim     Boehringer Ingelheim Pharmaceuticals    
  More Information


Responsible Party:   Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:   1100.1470, EUDRACT 2005-004330-40
First Received:   October 17, 2006
Last Updated:   July 30, 2008
ClinicalTrials.gov Identifier:   NCT00389207
Health Authority:   Spain: Agencia Espanola del Medicamento y Productos Sanitarios;   Germany: Federal Institute for Drugs and Medical Devices;   United States: Food and Drug Administration;   Great Britain: MHRA;   Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica);   Poland: Urzad Rejestracji Produktow Leczniczych;   Romania: National Medicines Agency, Bucharest;   Italy: Comitato Etico dell'Azienda Osp. Riuniti di Bergamo - Bergamo;   Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS);   Portugal: INFARMED - Instituto Nacional da Farmacia e do Medicamento;   Switzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products)

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Atazanavir
Immunologic Deficiency Syndromes
Virus Diseases
Nevirapine
Emtricitabine
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2008




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