Infection, Human Immunodeficiency VirusPhase 4NCT00441688
Prospective Epidemiological Study Of The Prevalence Of HLAB*5701 In HIV-1 Infected Patients
A Phase 4 study testing GI265235 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- GI265235
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 974 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2007to 1 Jun 2007
- Phase
- Phase 4
- 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
- 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.
Who cannot join
- none
About this study
Official title: 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.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- GI265235
- Keywords
- Human Immunodeficiency virus, HLAgenetics polymorphism
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI265235Drug
| Study group | Role | What they receive |
|---|---|---|
| GI265235 | Experimental | Not described Receives: Drug: GI265235 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
Percentage of participants with HLA-B*5701 in the major French ethnotypes in the study population
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.
Measured: Day 1
Number of participants with positive HLA-B*5701 screening results obtained with local laboratory
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study start15 Mar 2007
- Primary completion1 Jun 2007
- Study completion1 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Masking
- None (open label)
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441688
- Sponsor's protocol ID
- 109477
- Status last verified
- Aug 2017
- First submitted
- 28 Feb 2007
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Epidemiological Study of the Prevalence of HLAB*5701 in HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00441688
- Acronym / sponsor ID
- 109477
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency virus, HLAgenetics polymorphism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 15 Mar 2007 (actual)
- Primary completion
- 1 Jun 2007 (actual)
- Study completion
- 1 Jun 2007 (actual)
- First posted
- 1 Mar 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 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.
Study design
- Primary purpose
- Other
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GI265235 | Experimental | Drug: GI265235 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| GI265235 | Drug | GI265235 |
Primary outcome
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.
2 secondary outcomes
Percentage of participants with HLA-B*5701 in the major French ethnotypes in the study population
Time frame: Day 1
Number of participants with positive HLA-B*5701 screening results obtained with local laboratory
Time frame: Day 1
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 22 Aug 2017.
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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 study director
ViiV Healthcare
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GI265235 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare.
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 1 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Percentage of participants with HLA-B*5701 in the French HIV-1 infected population assessed using centralized screening assay results (time frame: Day 1). It is what the study was designed to measure, not a finding.
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 22 Aug 2017.