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Case-Control Viramune (Nevirapine) Toxicogenomics Study

31. juli 2013 oppdatert av: Boehringer Ingelheim

A Case-Control Toxicogenomics Study to Identify Unique Genetic Polymorphisms in Patients Who Have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity Within the First 8 Weeks of Nevirapine Therapy

Attempt to identify genetic polymorphisms in interrogated pathways which may be associated with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within the first 8 weeks of nevirapine therapy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

889

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Capital Federal, Argentina
        • 1100.1452.54001 Fundación Huésped
      • Capital Federal, Argentina
        • 1100.1452.54002 Funcei
      • Capital Federal, Argentina
        • 1100.1452.54003 Boehringer Ingelheim Investigational Site
      • Rosario, Argentina
        • 1100.1452.54004 Boehringer Ingelheim Investigational Site
  • Australia
    • New South Wales
      • DarlingHurst, New South Wales, Australia
        • 1100.1452.61005 Boehringer Ingelheim Investigational Site
      • Darlinghurst, New South Wales, Australia
        • 1100.1452.61004 Boehringer Ingelheim Investigational Site
      • Darlinghurst, New South Wales, Australia
        • 1100.1452.61006 Boehringer Ingelheim Investigational Site
    • Queensland
      • Miami, Queensland, Australia
        • 1100.1452.61003 Boehringer Ingelheim Investigational Site
    • Victoria
      • Carlton, Victoria, Australia
        • 1100.1452.61002 Boehringer Ingelheim Investigational Site
      • Melbourne, Victoria, Australia
        • 1100.1452.61008 Boehringer Ingelheim Investigational Site
      • South Yarra, Victoria, Australia
        • 1100.1452.61001 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1100.1452.01501 St. Paul's Hospital
      • Vancouver, British Columbia, Canada
        • 1100.1452.01504 Boehringer Ingelheim Investigational Site
    • Ontario
      • Toronto, Ontario, Canada
        • 1100.1452.01502 Toronto General Hospital
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater
        • 1100.1452.01006 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, Forente stater
        • 1100.1452.01013 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Baltimore, Connecticut, Forente stater
        • 1100.1452.99999 Boehringer Ingelheim Investigational Site
      • New Haven, Connecticut, Forente stater
        • 1100.1452.01011 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, Forente stater
        • 1100.1452.01003 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater
        • 1100.1452.01002 Boehringer Ingelheim Investigational Site
      • Springfield, Massachusetts, Forente stater
        • 1100.1452.01014 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, Forente stater
        • 1100.1452.01015 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, Forente stater
        • 1100.1452.01016 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Chapel hill, North Carolina, Forente stater
        • 1100.1452.01012 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forente stater
        • 1100.1452.01001 Boehringer Ingelheim Investigational Site
    • Texas
      • Fort Worth, Texas, Forente stater
        • 1100.1452.01004 Boehringer Ingelheim Investigational Site
  • Frankrike
      • Bordeaux, Frankrike
        • 1100.1452.3304A Hôpital Saint André
      • Lyon, Frankrike
        • 1100.1452.3306B Hop Hôtel Dieu
      • Lyon, Frankrike
        • 1100.1452.3311B Pavillon P
      • Lyon Cedex 3, Frankrike
        • 1100.1452.3311A Hôpital Edouard Herriot
      • Lyon cedex 2, Frankrike
        • 1100.1452.3306A Hôpital Hôtel Dieu
      • Lyon cedex 3, Frankrike
        • 1100.1452.3311C Hôpital Edouard Herriot
      • Lyon cedex 3, Frankrike
        • 1100.1452.3311D Hôpital Edouard Herriot
      • Nantes, Frankrike
        • 1100.1452.3305D Hôpital Hôtel Dieu
      • Nantes, Frankrike
        • 1100.1452.3305F Hôpital Hôtel Dieu
      • Nantes, Frankrike
        • 1100.1452.3305G Hôpital Hôtel Dieu
      • Nantes, Frankrike
        • 1100.1452.3305I Hôpital Hôtel Dieu
      • Nantes cedex 1, Frankrike
        • 1100.1452.3305A Hôpital hôtel Dieu
      • Nantes cedex 1, Frankrike
        • 1100.1452.3305B Hôpital hôtel Dieu
      • Nantes cedex 1, Frankrike
        • 1100.1452.3305C Hôpital hôtel Dieu
      • Nantes cedex 1, Frankrike
        • 1100.1452.3305E Hôpital hôtel Dieu
      • Nantes cedex 1, Frankrike
        • 1100.1452.3305H Hôpital hôtel Dieu
      • Paris, Frankrike
        • 1100.1452.3301A Hôpital Saint Louis
      • Paris, Frankrike
        • 1100.1452.3303A Hôpital de la Pité Salpêtrière
      • Paris, Frankrike
        • 1100.1452.3310A Hôpital Bichat Claude Bernard
      • Paris, Frankrike
        • 1100.1452.3310B Hôpital Bichat Claude Bernard
      • Paris, Frankrike
        • 1100.1452.3313B Hôpital Saint Antoine
      • Paris, Frankrike
        • 1100.1452.3313C Hôpital Saint Antoine
      • Paris, Frankrike
        • 1100.1452.3314A Hôpital Européen Georges Pompidou
      • Paris cedex 12, Frankrike
        • 1100.1452.3313A Hôpital Saint Antoine
      • Paris cedex 20, Frankrike
        • 1100.1452.3302A Hôpital Tenon
      • Toulouse, Frankrike
        • 1100.1452.3308B Hôpital Purpan
      • Toulouse cedex 9, Frankrike
        • 1100.1452.3308A Hôpital Purpan
      • Tourcoing cedex, Frankrike
        • 1100.1452.3307A Hôpital Guy Chateliez
      • Tourcoing cedex, Frankrike
        • 1100.1452.3307B Hôpital Guy Chateliez
      • Tourcoing cedex, Frankrike
        • 1100.1452.3307C Hôpital Guy Chateliez
      • Tourcoing cedex, Frankrike
        • 1100.1452.3307D Hôpital Guy Chateliez
      • Tourcoing cedex, Frankrike
        • 1100.1452.3307E Hôpital Guy Chateliez
      • Vandoeuvre les Nancy, Frankrike
        • 1100.1452.3312A Hôpital Brabois
  • Nederland
      • Amsterdam, Nederland
        • 1100.1452.31001 Academisch Medisch Centrum
      • Amsterdam, Nederland
        • 1100.1452.31002 Onze Lieve Vrouwen Gasthuis
  • Spania
      • Badalona, Spania
        • 1100.1452.34005 Boehringer Ingelheim Investigational Site
      • Barcelona, Spania
        • 1100.1452.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, Spania
        • 1100.1452.34002 Boehringer Ingelheim Investigational Site
      • Barcelona, Spania
        • 1100.1452.34004 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spania
        • 1100.1452.34003 Boehringer Ingelheim Investigational Site
      • Madrid, Spania
        • 1100.1452.34006 Boehringer Ingelheim Investigational Site
      • Madrid, Spania
        • 1100.1452.34007 Boehringer Ingelheim Investigational Site
      • Madrid, Spania
        • 1100.1452.34010 Boehringer Ingelheim Investigational Site
      • Madrid, Spania
        • 1100.1452.34011 Boehringer Ingelheim Investigational Site
      • Sevilla, Spania
        • 1100.1452.34009 Boehringer Ingelheim Investigational Site
  • Storbritannia
      • Birmingham, Storbritannia
        • 1100.1452.44006 Boehringer Ingelheim Investigational Site
      • Brighton, Storbritannia
        • 1100.1452.44004 Boehringer Ingelheim Investigational Site
      • Coventry, Storbritannia
        • 1100.1452.44001 Boehringer Ingelheim Investigational Site
      • London, Storbritannia
        • 1100.1452.44002 Boehringer Ingelheim Investigational Site
      • London, Storbritannia
        • 1100.1452.44005 Boehringer Ingelheim Investigational Site
      • London, Storbritannia
        • 1100.1452.44008 Boehringer Ingelheim Investigational Site
      • London, Storbritannia
        • 1100.1452.44009 Boehringer Ingelheim Investigational Site
      • Manchester, Storbritannia
        • 1100.1452.44003 Boehringer Ingelheim Investigational Site
      • Plaistow, London, Storbritannia
        • 1100.1452.44007 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan
        • 1100.1452.88602 Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan
        • 1100.1452.88603 E-Da Hospital
      • Kaohsiung, Taiwan
        • 1100.1452.88605 Chung-Ho Memorial Hospital, Kaohsiung Medical University
      • Taichung, Taiwan
        • 1100.1452.88606 China Medical University Hospital
      • Taipei, Taiwan
        • 1100.1452.88601 National Taiwan University Hospital
      • Taipei, Taiwan
        • 1100.1452.88604 Taipei City Hospital
  • Thailand
      • Bangkok, Thailand
        • 1100.1452.66001 Boehringer Ingelheim Investigational Site
      • Bangkok, Thailand
        • 1100.1452.66002 Boehringer Ingelheim Investigational Site
      • Khon Kaen, Thailand
        • 1100.1452.66003 Boehringer Ingelheim Investigational Site
  • Tyskland
      • Berlin, Tyskland
        • 1100.1452.4901 Boehringer Ingelheim Investigational Site
      • Berlin, Tyskland
        • 1100.1452.4902 Boehringer Ingelheim Investigational Site
      • Berlin, Tyskland
        • 1100.1452.9907 Boehringer Ingelheim Investigational Site
      • Bochum, Tyskland
        • 1100.1452.4903 Boehringer Ingelheim Investigational Site
      • Bonn, Tyskland
        • 1100.1452.4918 Boehringer Ingelheim Investigational Site
      • Düsseldorf, Tyskland
        • 1100.1452.4912 Boehringer Ingelheim Investigational Site
      • Essen, Tyskland
        • 1100.1452.4904 Boehringer Ingelheim Investigational Site
      • Frankfurt am Main, Tyskland
        • 1100.1452.4933 Boehringer Ingelheim Investigational Site
      • Hamburg, Tyskland
        • 1100.1452.4916 Boehringer Ingelheim Investigational Site
      • Hamburg, Tyskland
        • 1100.1452.4931 Boehringer Ingelheim Investigational Site
      • München, Tyskland
        • 1100.1452.4910 Boehringer Ingelheim Investigational Site
      • Ulm, Tyskland
        • 1100.1452.4900 Universitätsklinikum Ulm
      • Würzburg, Tyskland
        • 1100.1452.4932 Boehringer Ingelheim Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients Who Have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity Within the First 8 Weeks of Nevirapine Therapy

Beskrivelse

Inclusion Criteria:

Inclusion for Case

  1. Male or female patients >=18 years of age with HIV-1 infection who experienced one or more of the following adverse reactions within the first 8 weeks of starting nevirapine therapy:

    • Grade 3 or 4 LFT elevation (ALT or AST > 5X ULN) and any symptom consistent with clinical hepatitis (see Appendix 10.1)
    • Acute liver failure secondary to nevirapine therapy*
    • Functional group III or IV rash
    • *Acute liver failure is defined as serious liver injury usually requiring hospitalization that may lead to death or liver transplantation.

    Inclusion for Control

  2. Male or female patients >=18 years of age with HIV-1 infection who have been exposed to nevirapine therapy for at least 18 weeks and who do not meet any of the case inclusion criteria

Exclusion Criteria:

Exclusion for Cases

  1. Patients with any hepatotoxicity or rash event which in the investigators judgement is not related to nevirapine use (ex. hepatotoxicity due to alcohol or other medicinal use or rash due to other medicinal use).
  2. Patients who began abacavir or TMP-SMX (trimethoprim/sulfamethoxazole) therapy 2 weeks or less prior to or up to 8 weeks after initiating nevirapine therapy.

  3. Patients with AST or ALT elevations > 5 times the ULN (>= Grade 3) just prior to the initiation of nevirapine therapy.

    Exclusion for Controls

  4. Patients who discontinued nevirapine before completing 18 weeks of dosing with 200 mg/day for 2 weeks followed by 400 mg/day thereafter.
  5. Patients who developed functional group I, IIa or IIb rash within 18 weeks of starting nevirapine therapy, or any dermatologic condition that could plausibly be attributed to nevirapine.
  6. Patients with ALT or AST elevations >2.5 X ULN (>Grade 1) within 18 weeks of starting nevirapine therapy.
  7. Any hepatobiliary adverse event that could possibly be attributed to nevirapine.

  8. Patients who develop any systemic reaction attributable to nevirapine use during the first 18 weeks of nevirapine treatment such as flu-like symptoms, arthralgia, myalgia, or conjunctivitis.

    Exclusion for Cases and Controls

  9. Patients who have participated in the 2NN-Long-term Follow-up study (1100.1454)
  10. Patients with CD4 count 150 cells/mm3 prior to the initiation of nevirapine therapy (last available result measured 6 months prior to the initiation of nevirapine therapy).
  11. Evidence of acute co-infection with viral hepatitis.
  12. Patients taking prednisone, prednisolone, or immuno-modulatory medication within the first 8 weeks of nevirapine therapy.
  13. Patients who are unwilling to provide blood samples for DNA testing.
  14. Patients who did not sign informed consent and or authorization to release protected health information per local requirements.
  15. Patients without available liv

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
All study population
Legemiddel: Nevirapine
Patients with HIV-1 infection who have taken or are currently taking nevirapine

Hva måler studien?

Primære resultatmål

Resultatmål
Endpoints: relationship between nevirapine-related AEs and genetic polymorphisms loci: Drug metabolizing enzymes (e.g., cytochrome P450 isoforms) Drug transporters (e.g., MDR1 and OATP-C) Human Major Histocompatibility Complex region genes

Sekundære resultatmål

Resultatmål
Descriptive demographics comparing cases with matched controls in an attempt to link genetic polymorphisms associated with symptomatic hepatotoxicity or severe cutaneous toxicity (cases) to gender, race or other patient characteristics.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2006

Primær fullføring (Faktiske)

1. september 2008

Datoer for studieregistrering

Først innsendt

28. mars 2006

Først innsendt som oppfylte QC-kriteriene

2. april 2006

Først lagt ut (Anslag)

5. april 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. august 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. juli 2013

Sist bekreftet

1. juli 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1100.1452
  • 2005-004321-26

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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