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

Completed

• Conditions: HIV Infection

• Registration Number: NCT00435838
• Lead Sponsor: GlaxoSmithKline

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-15
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Study Start: 2007-03
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-13
• Last Update Posted: 2008-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030.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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇭 La Chaux-de-Fonds, Switzerland