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

NCT00441688 | Completed Phase 4

• 1 other identifier: 109477
• Study Type: interventional
• Target: 974
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infection, Human Immunodeficiency Virus

Keywords

Human Immunodeficiency virus; HLAgenetics polymorphism

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 1

Secondary Outcomes (2)

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

  Day 1

• Number of participants with positive HLA-B*5701 screening results obtained with local laboratory

  Day 1

Study Arms (1)

GI265235

EXPERIMENTAL

Drug: GI265235

Interventions

GI265235 DRUG

GI265235

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: March 15, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 22, 2017

Record last verified: 2017-08