MedDataX Logo

HLA-B*5701 And Hypersensitivity To Abacavir

NCT ID: NCT00373945

Last Updated: 2009-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This retrospective case-control study is being conducted to estimate the sensitivity of the pharmacogenetic marker, HLA-B\*5701 for hypersensitivity to abacavir (ABC HSR). The specificity of the marker, and its association with ABC HSR, as measured by odds ratios and 95% confidence intervals, will be evaluated as secondary endpoints. Cases will be defined in two ways - subjects who have clinically-suspected ABC HSR and a positive abacavir skin patch test reaction (CS-SPTPos) and subjects with clinically-suspected ABC HSR (CS-HSR), regardless of the results of skin patch testing. The study will include 40 CS-SPTPos Black cases matched with up to 200 abacavir-tolerant controls. In parallel, 40 CS-SPTPos White cases will be matched with up to 200 White controls. Some of the secondary analyses will use cases defined by clinical criteria alone (CS-HSR). Black and White subjects will be analyzed separately because of the differences in ABC HSR rates and in the carriage frequency of HLA-B\*5701.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

NCT00002364

HIV Infections
COMPLETED PHASE2

A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults

NCT02990325

HIV Infections Health Volunteers
COMPLETED PHASE1/PHASE2

Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone

NCT01605084

HIV
WITHDRAWN PHASE3

Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects

NCT00096746

HIV Infection
COMPLETED

Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women

NCT00326716

HIV Infection
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational Study

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with HIV-1 infection with clinically-suspected hypersensitivity to abacavir.
* Subjects must provide consent for skin patch testing and pharmacogenetic evaluation.

Exclusion Criteria

* Women found to be pregnant at baseline.
* Subjects with HIV-1 infection who have tolerated abacavir for at least 12 weeks without experiencing hypersensitivity to the drug.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GSK

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Beverly Hills, California, United States

Site Status

GSK Investigational Site

Loma Linda, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Newport Beach, California, United States

Site Status

GSK Investigational Site

Oakland, California, United States

Site Status

GSK Investigational Site

San Francisco, California, United States

Site Status

GSK Investigational Site

Tarzana, California, United States

Site Status

GSK Investigational Site

Denver, Colorado, United States

Site Status

GSK Investigational Site

Denver, Colorado, United States

Site Status

GSK Investigational Site

Norwalk, Connecticut, United States

Site Status

GSK Investigational Site

Fort Lauderdale, Florida, United States

Site Status

GSK Investigational Site

Fort Lauderdale, Florida, United States

Site Status

GSK Investigational Site

Hollywood, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Augusta, Georgia, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Lexington, Kentucky, United States

Site Status

GSK Investigational Site

Balitmore, Maryland, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

Springfield, Massachusetts, United States

Site Status

GSK Investigational Site

Detroit, Michigan, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Albany, New York, United States

Site Status

GSK Investigational Site

Catskill, New York, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Rochester, New York, United States

Site Status

GSK Investigational Site

The Bronx, New York, United States

Site Status

GSK Investigational Site

Valhalla, New York, United States

Site Status

GSK Investigational Site

Chapel Hill, North Carolina, United States

Site Status

GSK Investigational Site

Greenville, North Carolina, United States

Site Status

GSK Investigational Site

Akron, Ohio, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Fort Worth, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Longview, Texas, United States

Site Status

GSK Investigational Site

Tyler, Texas, United States

Site Status

GSK Investigational Site

Hampton, Virginia, United States

Site Status

GSK Investigational Site

Seattle, Washington, United States

Site Status

GSK Investigational Site

Spokane, Washington, United States

Site Status

GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHAPE

Identifier Type: -

Identifier Source: secondary_id

ABC107442

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of 1592U89 in HIV-Infected Patients
NCT00002388 COMPLETED PHASE1
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study
NCT00225017 COMPLETED PHASE3
Abacavir Pharmacokinetic Study in the Absence/Presence of Darunavir/Ritonavir or Raltegravir in HIV-infected Subjects
NCT00765271 COMPLETED PHASE1
A Prospective Double-Blind Study of Retrovir in Early HIV Infection
NCT00002045 COMPLETED NA
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
NCT01236235 COMPLETED
Microboosting of Atazanavir 300 mg With 50 mg Versus 100mg Ritonavir Daily in HIV-infected Patients: a Pharmacokinetic Study
NCT02034838 COMPLETED PHASE1
Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
NCT00038519 COMPLETED PHASE2/PHASE3
Drug Interaction Study
NCT00646776 COMPLETED PHASE1
Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects
NCT00357188 COMPLETED PHASE1
Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
NCT00384904 COMPLETED PHASE4
Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
NCT00234975 COMPLETED PHASE4
A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
NCT00004581 COMPLETED PHASE3
A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
NCT00135395 COMPLETED PHASE3
A Long Term Safety Study of Apricitabine in HIV-infected Patients
NCT00686270 WITHDRAWN PHASE3
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
NCT00838162 COMPLETED PHASE2
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
NCT00362726 COMPLETED PHASE1
Comparison of Abacavir Following Once-Daily And Twice-Daily Administration In HIV Infected Subjects
NCT00320307 COMPLETED PHASE1
Pharmacokinetic Characteristics and Anti-Inflammatory Effects of Aprepitant In HIV-Infected Subjects
NCT02154360 COMPLETED PHASE1
Atazanavir Twice Daily
NCT00357721 COMPLETED PHASE1
Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
NCT00038532 COMPLETED PHASE2
A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy
NCT00067782 COMPLETED PHASE3
Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r
NCT00476502 COMPLETED
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
NCT00940771 COMPLETED PHASE4
Atazanavir for HIV Infected Individuals: An Early Access Program
NCT00046345 NO_LONGER_AVAILABLE
A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
NCT00002198 COMPLETED PHASE1