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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00435838 |
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Date of registration:
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15/02/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701
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Scientific title:
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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Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00435838 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Austria
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Belgium
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Italy
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Russian Federation
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Slovenia
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Spain
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Switzerland
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Contacts
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Name:
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GSK Clinical Trials, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infection
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Intervention(s)
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Drug: No Intervention -- Observational study
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Secondary ID(s)
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CNA108223
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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