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

HIV Infection Clinical Trial

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Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435838
• Other study ID #: CNA108223
• Status: Completed
• Phase: N/A
• First received: February 15, 2007
• Last updated: October 13, 2008
• Start date: March 2007

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030.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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• No Intervention -- Observational study

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Graz
Austria	GSK Investigational Site	Innsbruck
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Italy	GSK Investigational Site	Bolzano	Trentino-Alto Adige
Italy	GSK Investigational Site	Legnano (MI	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Rimini	Emilia-Romagna
Italy	GSK Investigational Site	Roma	Lazio
Russian Federation	GSK Investigational Site	Belgorod
Russian Federation	GSK Investigational Site	Orel
Russian Federation	GSK Investigational Site	Volgograd
Slovenia	GSK Investigational Site	Ljubljana
Spain	GSK Investigational Site	Alcala de Henares
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Valencia
Switzerland	GSK Investigational Site	La Chaux-de-Fonds

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Belgium,  Italy,  Russian Federation,  Slovenia,  Spain,  Switzerland,