HIV InfectionNCT00373945
HLA-B*5701 And Hypersensitivity To Abacavir
An observational study of HIV Infection, run by GlaxoSmithKline at 55 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Observational Study
- How many people
- 280 participants
- Where
- 55 sitesUnited States
- Study dates
- Aug 2006to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with HIV-1 infection with clinically-suspected hypersensitivity to abacavir.
- Subjects must provide consent for skin patch testing and pharmacogenetic evaluation.
Who cannot join
- 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.
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
GSK Investigational Site
Akron, Ohio, 44304
GSK Investigational Site
Albany, New York, 12208
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30309
GSK Investigational Site
Atlanta, Georgia, 30339
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Balitmore, Maryland, 21287
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Baltimore, Maryland, 21229-5299
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Catskill, New York, 12414
GSK Investigational Site
Chapel Hill, North Carolina, 27514
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80204
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Greenville, North Carolina, 27834
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Hollywood, Florida, 33020
GSK Investigational Site
Houston, Texas, 77027
GSK Investigational Site
Houston, Texas, 77098
GSK Investigational Site
Lexington, Kentucky, 40536
GSK Investigational Site
Little Rock, Arkansas, 72207
GSK Investigational Site
Loma Linda, California, 92357
GSK Investigational Site
Longview, Texas, 75605
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
Los Angeles, California, 90069
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
New York, New York, 10011
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
Norwalk, Connecticut, 06851
GSK Investigational Site
Oakland, California, 94609
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
Orlando, Florida, 32812
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Portland, Oregon, 97227
GSK Investigational Site
Rochester, New York, 14604
GSK Investigational Site
San Francisco, California, 94115-1931
GSK Investigational Site
Seattle, Washington, 98122
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
Springfield, Massachusetts, 01107
GSK Investigational Site
St Louis, Missouri, 63108
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
Tarzana, California, 91356
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Tyler, Texas, 75708
GSK Investigational Site
Valhalla, New York, 10595
About this study
Official title: A Retrospective Case-Control Study to Estimate the Sensitivity and Specificity of a Pharmacogenetic Marker (HLA-B*5701) in Subjects With and Without Hypersensitivity to Abacavir.
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.
- Conditions
- HIV Infection
- Being tested
- Observational Study
- Keywords
- HLA-B*5701, pharmacogenetic marker, hypersensitivity to abacavir,, retrospective analysis
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startAug 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373945
- Sponsor's protocol ID
- ABC107442
- Other IDs
- SHAPE
- Status last verified
- May 2009
- First submitted
- 7 Sep 2006
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Case-Control Study to Estimate the Sensitivity and Specificity of a Pharmacogenetic Marker (HLA-B*5701) in Subjects With and Without Hypersensitivity to Abacavir.
- ClinicalTrials.gov ID
- NCT00373945
- Acronym / sponsor ID
- ABC107442
- Conditions
- HIV Infection
- Keywords
- HLA-B*5701, pharmacogenetic marker, hypersensitivity to abacavir,, retrospective analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with HIV-1 infection with clinically-suspected hypersensitivity to abacavir.
- Subjects must provide consent for skin patch testing and pharmacogenetic evaluation.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by GlaxoSmithKline at 55 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2009.