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

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.

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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GI265235

Drug

Primary outcomes

Percentage of participants with HLA-B*5701 in the French HIV-1 infected population assessed using centralized screening assay results

Time frame: Day 1

Tissue sample (cheek cells and blood sample) were collected from the participants to assess HLA-B*5701 status using centralized screening assay in the centralized laboratory.The prevalence was calculated as the ratio of the number of participants with HLA-B*5701 positive divided by the total number of participants with available HLAB*5701 result multiplied by 100.

Secondary outcomes

Percentage of participants with HLA-B*5701 in the major French ethnotypes in the study population

Time frame: Day 1

Participants attended a single visit where an assessment of the participant's demographic background (age, sex , mode of HIV transmission, ethnicity, country of origin and parental country of origin) was conducted, and tissue samples (buccal cells and blood sample) were collected to determine the presence of HLA-B*5701 genotype by both central and local laboratories using centralized screening assay. The prevalence was calculated as the ratio of the number of participants with HLA-B*5701 positive divided by the total number of subjects with available HLAB*5701 result multiplied by 100. Data is presented for the prevalence of HLA-B*5701 in all the ethnotypes.
Number of participants with positive HLA-B*5701 screening results obtained with local laboratory

Time frame: Day 1

Tissue sample (cheek cells and blood sample) were collected from the participants to assess HLA-B*5701 status using centralized screening assay in the local laboratory. The prevalence was calculated as the ratio of the number of participants with HLA-B*5701 positive divided by the total number of subjects with available HLAB*5701 result. According to local laboratory, participants with positive results have been summarized here.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

GlaxoSmithKline

Registry information

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Mar 1, 2007
Registry last updated: Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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