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Case-Control Viramune (Nevirapine) Toxicogenomics Study

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00310843
First received: March 28, 2006
Last updated: July 31, 2013
Last verified: July 2013

March 28, 2006
July 31, 2013
February 2006
September 2008   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00310843 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Case-Control Viramune (Nevirapine) Toxicogenomics Study
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

HIV Infections
Drug: Nevirapine
Patients with HIV-1 infection who have taken or are currently taking nevirapine
All study population
Intervention: Drug: Nevirapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
889
Not Provided
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   France,   Germany,   Netherlands,   Spain,   Taiwan,   Thailand,   United Kingdom
 
NCT00310843
1100.1452, 2005-004321-26
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP