HLA-B*5701 And Hypersensitivity To Abacavir
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This retrospective case-control study is being conducted to estimate the sensitivity of the pharmacogenetic marker, HLA-B*5701 for hypersensitivity to abacavir (ABC HSR). The specificity of the marker, and its association with ABC HSR, as measured by odds ratios and 95% confidence intervals, will be evaluated as secondary endpoints. Cases will be defined in two ways - subjects who have clinically-suspected ABC HSR and a positive abacavir skin patch test reaction (CS-SPTPos) and subjects with clinically-suspected ABC HSR (CS-HSR), regardless of the results of skin patch testing. The study will include 40 CS-SPTPos Black cases matched with up to 200 abacavir-tolerant controls. In parallel, 40 CS-SPTPos White cases will be matched with up to 200 White controls. Some of the secondary analyses will use cases defined by clinical criteria alone (CS-HSR). Black and White subjects will be analyzed separately because of the differences in ABC HSR rates and in the carriage frequency of HLA-B*5701.
Condition | Intervention |
---|---|
HIV Infection |
Drug: Observational Study |
Study Type: | Observational |
Study Design: | Time Perspective: Retrospective |
Official Title: | A Retrospective Case-Control Study to Estimate the Sensitivity and Specificity of a Pharmacogenetic Marker (HLA-B*5701) in Subjects With and Without Hypersensitivity to Abacavir. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Subjects with HIV-1 infection with clinically-suspected hypersensitivity to abacavir.
- Subjects must provide consent for skin patch testing and pharmacogenetic evaluation.
Exclusion criteria:
- Women found to be pregnant at baseline.
- Subjects with HIV-1 infection who have tolerated abacavir for at least 12 weeks without experiencing hypersensitivity to the drug.
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Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
No publications provided
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00373945 History of Changes |
Other Study ID Numbers: | ABC107442, SHAPE |
Study First Received: | September 7, 2006 |
Last Updated: | May 15, 2009 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
HLA-B*5701 pharmacogenetic marker hypersensitivity to abacavir, retrospective analysis |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hypersensitivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Abacavir Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 14, 2013