Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
HLA-B*5701 And Hypersensitivity To Abacavir
NCT00373945 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Observational Study
Study Locations (20)
California
- GSK Investigational Site — Beverly Hills
- GSK Investigational Site — Loma Linda
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — Newport Beach
- GSK Investigational Site — Oakland
- GSK Investigational Site — San Francisco
- GSK Investigational Site — Tarzana
Florida
- GSK Investigational Site — Fort Lauderdale
- GSK Investigational Site — Fort Lauderdale
- GSK Investigational Site — Hollywood
- GSK Investigational Site — Orlando
- GSK Investigational Site — Orlando
Colorado
- GSK Investigational Site — Denver
- GSK Investigational Site — Denver
Georgia
- GSK Investigational Site — Atlanta
- GSK Investigational Site — Atlanta
Alabama
- GSK Investigational Site — Birmingham
Arkansas
- GSK Investigational Site — Little Rock
Connecticut
- GSK Investigational Site — Norwalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00373945
The ClinicalTrials.gov registry entry for NCT00373945 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 1 intervention — of which Observational Study is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00373945 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00373945 about?
NCT00373945 is a clinical study titled "HLA-B*5701 And Hypersensitivity To Abacavir". 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 b...
What is the current status of trial NCT00373945?
This trial is currently completed. The enrollment target is 280 participants. The study started on 2006-08. Estimated completion is 2007-08.
What conditions does trial NCT00373945 study?
This clinical trial studies the following conditions: HIV Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00373945?
The interventions under investigation include: Observational Study (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00373945?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00373945 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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