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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00310843 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Procedure: DNA Blood Sampling |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | A Case and Control Toxicogenomics Study to Identify Genetic Locus or Loci in Patients Who Have Experienced Symptomatic Hepatotoxicity and Severe Skin Reactions Within the First 8 Weeks of Nevirapine Therapy |
Enrollment: | 889 |
Study Start Date: | February 2006 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion for Case
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:
Exclusion Criteria:
Exclusion for Cases
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
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1100.1452, 2005-004321-26 |
Study First Received: | March 28, 2006 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00310843 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Responsilble Ethics Committee; Canada: Health Canada-Protocol Review not required; France: Agence Française de Sécurité Sanitaire des Produits de Santé; Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medical Devices); Great Britain: MHRA; Netherlands: AMC (Academisch Medisch Centrum); Spain: Spanish Agency for Medicines and Health Products; Taiwan: Department of Health, Executive Yuan, Taiwan; Thailand: Ministry of Public Health; United States: Food and Drug Administration |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |