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NCT00373945 · ClinicalTrials.gov registry record
HLA-B*5701 And Hypersensitivity To Abacavir
A clinical trial of HIV Infection, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 280
- Enrollment target
- 20
- Study locations
NCT00373945: Completed study of HIV Infection, sponsored by GlaxoSmithKline.
NCT00373945 is a study of HIV Infection that has completed, run by GlaxoSmithKline. The registered enrollment target is 280 participants, above the 239-participant average among 73 other HIV Infection trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00373945, a study of HIV Infection, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 280 participants
- Enrollment target
- 20
- Study locations
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 |
What the finished NCT00373945 record still lists
NCT00373945 is an observational study that tracks outcomes without assigning an intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 239-participant average among 73 other HIV Infection trials with a reported enrollment target (17% higher).
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.
NCT00373945 names 20 study sites across 7 states, led by California, Florida, Colorado.
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.
What interventions are being tested in trial NCT00373945?
The interventions under investigation include: Observational Study (DRUG).
Who is sponsoring clinical trial NCT00373945?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00373945's enrollment target sits among peer trials
280 16th of 73 higher than 58 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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