Prospective Epidemiological Study Of The Prevalence Of HLAB*5701 In HIV-1 Infected Patients

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: GI265235

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441688

109477

Details and patient eligibility

About

This study is a cross sectional observational study to evaluate the prevalence of HLA-B*5701 in the major French ethnotypes.

Any HIV-1 infected subject will be eligible for this study including antiretroviral therapy (ART) naÃ-ve and experienced subjects irrespective of abacavir use, as well as subjects previously tested for HLA-B*5701. Subjects will be approached during a standard clinic visit, and all subjects will be consented prior to any study specific procedure. Subjects will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B*5701 status by central and local methodologies.

Enrollment: 974 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-1 infected patients, ART naive or experienced over the age of 18 years.
• Patients must be either affiliated to or beneficiary of a social security category.
• Patient is willing and able to understand and provide written informed consent prior to participation in this study.

Exclusion criteria

• none

Trial design

974 participants in 1 patient group

GI265235

Experimental group

Treatment:

Drug: GI265235