HIV InfectionNCT00435838
A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701
An observational study of HIV Infection, run by GlaxoSmithKline at 25 sites in 7 countries.
Trial summary
This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of hypersensitivity reactions to abacavir). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 35 participants
- Where
- 25 sitesin 7 countries
- Study dates
- Mar 2007to not given
- 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 who have received notification not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030.
- Subjects willing and able to understand and provide written informed consent prior to participation in this study.
- French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Who cannot join
- Subjects who were not enrolled in the CNA106030 study
- Subjects who are not HLA-B*5701 positive
- Subjects who do not consent to being told their HLA-B*5701 status
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
Spain7 sites
GSK Investigational Site
Alcalá de Henares, 28805
GSK Investigational Site
Alicante, 03010
GSK Investigational Site
Badalona, 08916
GSK Investigational Site
Barcelona, 08907
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Málaga, 29020
GSK Investigational Site
Valencia, 46015
Italy6 sites
GSK Investigational Site
Bolzano, Trentino-Alto Adige, 39100
GSK Investigational Site
Legnano (MI, Lombardy, 20025
GSK Investigational Site
Milan, Lombardy, 20142
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Rimini, Emilia-Romagna, 47900
GSK Investigational Site
Rome, Lazio, 00185
Austria5 sites
GSK Investigational Site
Graz, A-8020
GSK Investigational Site
Innsbruck, A-6020
GSK Investigational Site
Salzburg, A-5020
GSK Investigational Site
Vienna, A-1090
GSK Investigational Site
Vienna, A-1140
Russia3 sites
GSK Investigational Site
Belgorod, 308036
GSK Investigational Site
Oryol, 302040
GSK Investigational Site
Volgograd, 400040
Belgium2 sites
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Brussels, 1070
About this study
Official title: A Retrospective, Multi-Centre Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result
This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35 subjects who withdrew from CNA106030 when found to be HLA-B*5701 positive. HIV disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected
- Conditions
- HIV Infection
- Being tested
- No Intervention -- Observational study
- Keywords
- HLa-B*5701 Abacavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention -- Observational studyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startMar 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
- 35 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, PhD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435838
- Sponsor's protocol ID
- CNA108223
- Status last verified
- Oct 2008
- First submitted
- 15 Feb 2007
- Last updated
- 15 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi-Centre Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result
- ClinicalTrials.gov ID
- NCT00435838
- Acronym / sponsor ID
- CNA108223
- Conditions
- HIV Infection
- Keywords
- HLa-B*5701 Abacavir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- First posted
- 16 Feb 2007 (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 is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35 subjects who withdrew from CNA106030 when found to be HLA-B*5701 positive. HIV disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected
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 (3 listed)
- Subjects who have received notification not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030.
- Subjects willing and able to understand and provide written informed consent prior to participation in this study.
- French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Key exclusion criteria (3 listed)
- Subjects who were not enrolled in the CNA106030 study
- Subjects who are not HLA-B*5701 positive
- Subjects who do not consent to being told their HLA-B*5701 status
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 |
|---|---|---|
| No Intervention -- 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 15 Oct 2008.
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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, PhD study director
GlaxoSmithKline
25 sites in 7 countries: 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 25 sites in 7 countries.
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 3 inclusion and 3 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 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain, Italy, Austria, Russia, Belgium and 2 more countries. 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 15 Oct 2008.