Case-Control Viramune (Nevirapine) Toxicogenomics Study
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||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|
- 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
- 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.
|Study Start Date:||February 2006|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|All study population||
Patients with HIV-1 infection who have taken or are currently taking nevirapine
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|