A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701
A Retrospective, Multi-Centre Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result
1 other identifier
observational
35
7 countries
25
Brief Summary
This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B\*5701 can reduce the incidence of hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35 subjects who withdrew from CNA106030 when found to be HLA-B\*5701 positive. HIV disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2007
CompletedFirst Posted
Study publicly available on registry
February 16, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedOctober 15, 2008
October 1, 2008
February 15, 2007
October 13, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who have received notification not to receive abacavir in the CNA106030 study because of a positive HLA-B\*5701 screen result, and were subsequently withdrawn from protocol CNA106030.
- Subjects willing and able to understand and provide written informed consent prior to participation in this study.
You may not qualify if:
- Subjects who were not enrolled in the CNA106030 study
- Subjects who are not HLA-B\*5701 positive
- Subjects who do not consent to being told their HLA-B\*5701 status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (25)
GSK Investigational Site
Graz, A-8020, Austria
GSK Investigational Site
Innsbruck, A-6020, Austria
GSK Investigational Site
Salzburg, A-5020, Austria
GSK Investigational Site
Vienna, A-1090, Austria
GSK Investigational Site
Vienna, A-1140, Austria
GSK Investigational Site
Brussels, 1000, Belgium
GSK Investigational Site
Brussels, 1070, Belgium
GSK Investigational Site
Rimini, Emilia-Romagna, 47900, Italy
GSK Investigational Site
Rome, Lazio, 00185, Italy
GSK Investigational Site
Legnano (MI, Lombardy, 20025, Italy
GSK Investigational Site
Milan, Lombardy, 20142, Italy
GSK Investigational Site
Bolzano, Trentino-Alto Adige, 39100, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Belgorod, 308036, Russia
GSK Investigational Site
Oryol, 302040, Russia
GSK Investigational Site
Volgograd, 400040, Russia
GSK Investigational Site
Ljubljana, 1000, Slovenia
GSK Investigational Site
Alcalá de Henares, 28805, Spain
GSK Investigational Site
Alicante, 03010, Spain
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08907, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Málaga, 29020, Spain
GSK Investigational Site
Valencia, 46015, Spain
GSK Investigational Site
La Chaux-de-Fonds, CH 2301, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, PhD
GlaxoSmithKline