HLA-B*5701 And Hypersensitivity To Abacavir - Full Text View

Purpose

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	Phase
HIV	Drug: Observational Study	Phase IV

MedlinePlus related topics:

Allergy

ChemIDplus related topics:

Abacavir Abacavir sulfate

U.S. FDA Resources

Study Type:	Observational
Study Design:	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.

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	280
Study Start Date:	August 2006
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373945

Show 87 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	ABC107442, SHAPE
First Received:	September 7, 2006
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00373945
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HLA-B*5701

pharmacogenetic marker

hypersensitivity to abacavir,

retrospective analysis

Study placed in the following topic categories:

Hypersensitivity

HIV Infections

Acquired Immunodeficiency Syndrome

Abacavir

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-HIV Agents

Anti-Retroviral Agents

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Therapeutic Uses

Enzyme Inhibitors

Antiviral Agents

Pharmacologic Actions

Nucleic Acid Synthesis Inhibitors

Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00373945