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Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00435838

Enrollment

Registered

2007-02-16

Start date

2007-03-31

Completion date

Unknown

Last updated

2008-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HLa-B*5701 Abacavir

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

Interventions

DRUGNo Intervention -- Observational study

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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not to receive abacavir in the CNA106030 study because of a positive HLA-B\*5701 screen result, and were subsequently withdrawn from protocol CNA106030.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

Countries

Austria, Belgium, Italy, Russia, Slovenia, Spain, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026