A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701 - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00435838

Purpose

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

Condition	Intervention
HIV Infection	Drug: No Intervention -- Observational study

MedlinePlus related topics: AIDS

Drug Information available for: Abacavir Abacavir sulfate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Retrospective
Official Title:	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Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	35
Study Start Date:	March 2007

Eligibility

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

Criteria

Inclusion Criteria:

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not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030.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.
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435838

Locations

Austria
GSK Investigational Site
Vienna, Austria, A-1140
GSK Investigational Site
Vienna, Austria, A-1090
GSK Investigational Site
Salzburg, Austria, A-5020
GSK Investigational Site
Innsbruck, Austria, A-6020
GSK Investigational Site
Graz, Austria, A-8020
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Brussels, Belgium, 1070
Italy, Emilia-Romagna
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
Italy, Lazio
GSK Investigational Site
Roma, Lazio, Italy, 00185
Italy, Lombardia
GSK Investigational Site
Milano, Lombardia, Italy, 20142
GSK Investigational Site
Legnano (MI, Lombardia, Italy, 20025
Italy, Trentino-Alto Adige
GSK Investigational Site
Bolzano, Trentino-Alto Adige, Italy, 39100
Italy, Veneto
GSK Investigational Site
Padova, Veneto, Italy, 35128
Russian Federation
GSK Investigational Site
Volgograd, Russian Federation, 400040
GSK Investigational Site
Orel, Russian Federation, 302040
GSK Investigational Site
Belgorod, Russian Federation, 308036
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, 1000
Spain
GSK Investigational Site
Barcelona, Spain, 08907
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Alicante, Spain, 03010
GSK Investigational Site
Valencia, Spain, 46015
GSK Investigational Site
Alcala de Henares, Spain, 28805
GSK Investigational Site
Malaga, Spain, 29020
Switzerland
GSK Investigational Site
La Chaux-de-Fonds, Switzerland, CH 2301

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, PhD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CNA108223
Study First Received:	February 15, 2007
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00435838
Health Authority:	Italy: Ministry of Health

Keywords provided by GlaxoSmithKline:

HLa-B*5701 Abacavir

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Abacavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 13, 2009