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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 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.

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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

HIV Infection

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

FieldValue
Enrollment Target 280 participants
Start Date 2006-08
Est. Completion 2007-08

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00373945

The ClinicalTrials.gov registry entry for NCT00373945 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 239-participant average among 73 other HIV Infection trials with a reported enrollment target (17% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.