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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00477308 |
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Date of registration:
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20/05/2007 |
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Primary sponsor: |
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Public title:
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Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
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Scientific title:
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Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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95 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00477308 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Tawee Chotpitayasunondh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Queen Sirikit National Institute of Child Health, Bangkok |
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Name:
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Kiat Ruxrungtham, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All children from HIV-NAT 013 phase I
Exclusion Criteria:
- No inform consent obtained
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Procedure: salvage therapy
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Primary Outcome(s)
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Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy
[Time Frame: 1 time point (Cross Sectional Study)]
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Secondary Outcome(s)
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Changes of mutation in children within the 3 groups, and
[Time Frame: 1 time point]
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Comparison outcome of children in the 3 groups,
[Time Frame: 1 time point]
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Effect of previously unreported mutations, minor and others, on treatment outcome
[Time Frame: 1 time point]
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Secondary ID(s)
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HIV-NAT 013 phase II
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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