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Case-Control Viramune (Nevirapine) Toxicogenomics Study

31. juli 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

889

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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
  • Australien
    • New South Wales
      • DarlingHurst, New South Wales, Australien
        • 1100.1452.61005 Boehringer Ingelheim Investigational Site
      • Darlinghurst, New South Wales, Australien
        • 1100.1452.61004 Boehringer Ingelheim Investigational Site
      • Darlinghurst, New South Wales, Australien
        • 1100.1452.61006 Boehringer Ingelheim Investigational Site
    • Queensland
      • Miami, Queensland, Australien
        • 1100.1452.61003 Boehringer Ingelheim Investigational Site
    • Victoria
      • Carlton, Victoria, Australien
        • 1100.1452.61002 Boehringer Ingelheim Investigational Site
      • Melbourne, Victoria, Australien
        • 1100.1452.61008 Boehringer Ingelheim Investigational Site
      • South Yarra, Victoria, Australien
        • 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
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige
        • 1100.1452.44006 Boehringer Ingelheim Investigational Site
      • Brighton, Det Forenede Kongerige
        • 1100.1452.44004 Boehringer Ingelheim Investigational Site
      • Coventry, Det Forenede Kongerige
        • 1100.1452.44001 Boehringer Ingelheim Investigational Site
      • London, Det Forenede Kongerige
        • 1100.1452.44002 Boehringer Ingelheim Investigational Site
      • London, Det Forenede Kongerige
        • 1100.1452.44005 Boehringer Ingelheim Investigational Site
      • London, Det Forenede Kongerige
        • 1100.1452.44008 Boehringer Ingelheim Investigational Site
      • London, Det Forenede Kongerige
        • 1100.1452.44009 Boehringer Ingelheim Investigational Site
      • Manchester, Det Forenede Kongerige
        • 1100.1452.44003 Boehringer Ingelheim Investigational Site
      • Plaistow, London, Det Forenede Kongerige
        • 1100.1452.44007 Boehringer Ingelheim Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
        • 1100.1452.01006 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, Forenede Stater
        • 1100.1452.01013 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Baltimore, Connecticut, Forenede Stater
        • 1100.1452.99999 Boehringer Ingelheim Investigational Site
      • New Haven, Connecticut, Forenede Stater
        • 1100.1452.01011 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater
        • 1100.1452.01003 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • 1100.1452.01002 Boehringer Ingelheim Investigational Site
      • Springfield, Massachusetts, Forenede Stater
        • 1100.1452.01014 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater
        • 1100.1452.01015 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, Forenede Stater
        • 1100.1452.01016 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Chapel hill, North Carolina, Forenede Stater
        • 1100.1452.01012 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater
        • 1100.1452.01001 Boehringer Ingelheim Investigational Site
    • Texas
      • Fort Worth, Texas, Forenede Stater
        • 1100.1452.01004 Boehringer Ingelheim Investigational Site
  • Frankrig
      • Bordeaux, Frankrig
        • 1100.1452.3304A Hôpital Saint André
      • Lyon, Frankrig
        • 1100.1452.3306B Hop Hôtel Dieu
      • Lyon, Frankrig
        • 1100.1452.3311B Pavillon P
      • Lyon Cedex 3, Frankrig
        • 1100.1452.3311A Hôpital Edouard Herriot
      • Lyon cedex 2, Frankrig
        • 1100.1452.3306A Hôpital Hôtel Dieu
      • Lyon cedex 3, Frankrig
        • 1100.1452.3311C Hôpital Edouard Herriot
      • Lyon cedex 3, Frankrig
        • 1100.1452.3311D Hôpital Edouard Herriot
      • Nantes, Frankrig
        • 1100.1452.3305D Hôpital Hôtel Dieu
      • Nantes, Frankrig
        • 1100.1452.3305F Hôpital Hôtel Dieu
      • Nantes, Frankrig
        • 1100.1452.3305G Hôpital Hôtel Dieu
      • Nantes, Frankrig
        • 1100.1452.3305I Hôpital Hôtel Dieu
      • Nantes cedex 1, Frankrig
        • 1100.1452.3305A Hôpital hôtel Dieu
      • Nantes cedex 1, Frankrig
        • 1100.1452.3305B Hôpital hôtel Dieu
      • Nantes cedex 1, Frankrig
        • 1100.1452.3305C Hôpital hôtel Dieu
      • Nantes cedex 1, Frankrig
        • 1100.1452.3305E Hôpital hôtel Dieu
      • Nantes cedex 1, Frankrig
        • 1100.1452.3305H Hôpital hôtel Dieu
      • Paris, Frankrig
        • 1100.1452.3301A Hôpital Saint Louis
      • Paris, Frankrig
        • 1100.1452.3303A Hôpital de la Pité Salpêtrière
      • Paris, Frankrig
        • 1100.1452.3310A Hôpital Bichat Claude Bernard
      • Paris, Frankrig
        • 1100.1452.3310B Hôpital Bichat Claude Bernard
      • Paris, Frankrig
        • 1100.1452.3313B Hôpital Saint Antoine
      • Paris, Frankrig
        • 1100.1452.3313C Hôpital Saint Antoine
      • Paris, Frankrig
        • 1100.1452.3314A Hôpital Européen Georges Pompidou
      • Paris cedex 12, Frankrig
        • 1100.1452.3313A Hôpital Saint Antoine
      • Paris cedex 20, Frankrig
        • 1100.1452.3302A Hôpital Tenon
      • Toulouse, Frankrig
        • 1100.1452.3308B Hôpital Purpan
      • Toulouse cedex 9, Frankrig
        • 1100.1452.3308A Hôpital Purpan
      • Tourcoing cedex, Frankrig
        • 1100.1452.3307A Hôpital Guy Chateliez
      • Tourcoing cedex, Frankrig
        • 1100.1452.3307B Hôpital Guy Chateliez
      • Tourcoing cedex, Frankrig
        • 1100.1452.3307C Hôpital Guy Chateliez
      • Tourcoing cedex, Frankrig
        • 1100.1452.3307D Hôpital Guy Chateliez
      • Tourcoing cedex, Frankrig
        • 1100.1452.3307E Hôpital Guy Chateliez
      • Vandoeuvre les Nancy, Frankrig
        • 1100.1452.3312A Hôpital Brabois
  • Holland
      • Amsterdam, Holland
        • 1100.1452.31001 Academisch Medisch Centrum
      • Amsterdam, Holland
        • 1100.1452.31002 Onze Lieve Vrouwen Gasthuis
  • Spanien
      • Badalona, Spanien
        • 1100.1452.34005 Boehringer Ingelheim Investigational Site
      • Barcelona, Spanien
        • 1100.1452.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, Spanien
        • 1100.1452.34002 Boehringer Ingelheim Investigational Site
      • Barcelona, Spanien
        • 1100.1452.34004 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, Spanien
        • 1100.1452.34003 Boehringer Ingelheim Investigational Site
      • Madrid, Spanien
        • 1100.1452.34006 Boehringer Ingelheim Investigational Site
      • Madrid, Spanien
        • 1100.1452.34007 Boehringer Ingelheim Investigational Site
      • Madrid, Spanien
        • 1100.1452.34010 Boehringer Ingelheim Investigational Site
      • Madrid, Spanien
        • 1100.1452.34011 Boehringer Ingelheim Investigational Site
      • Sevilla, Spanien
        • 1100.1452.34009 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
All study population
Medicin: Nevirapine
Patients with HIV-1 infection who have taken or are currently taking nevirapine

Hvad måler undersøgelsen?

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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2006

Primær færdiggørelse (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

28. marts 2006

Først indsendt, der opfyldte QC-kriterier

2. april 2006

Først opslået (Skøn)

5. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2013

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1100.1452
  • 2005-004321-26

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med Nevirapine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in El Salvador

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner