Viewing Study NCT00477308



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Last Modification Date: 2024-10-26 @ 9:33 AM
Study NCT ID: NCT00477308
Status: COMPLETED
Last Update Posted: 2020-07-17
First Post: 2007-05-20

Brief Title: Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Organization: The HIV Netherlands Australia Thailand Research Collaboration

Study Overview

Official Title: Clinical Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
Status: COMPLETED
Status Verified Date: 2020-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In HIV-NAT 013 phase I study genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations
Detailed Description: The HIV-NAT 013 study conducted in 2003 evaluated prevalence and pattern of RT mutation in 95 children treated with dual NRTI The study showed almost all children to have some degree of NRTI resistance and 40 with multi NRTI resistance The mutation reported was major mutation

After the study the patients were managed based on the physicians judgment using genotyping results The 95 patients in HIV-NAT 013 are categorized into 3 groups

1 No viral resistance
2 Low grade resistance with or without clinical immunological failure
3 High grade resistance with or without clinical immunological failure

There are limited prospective studies evaluating outcome of decision regarding salvage therapy after genotyping results

There are also new mutations that are not considered major mutation that may affect treatment outcome

Knowledge learned from this study will benefit Thai children with NRTI resistance by helping pediatricians better choose salvage treatment options

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None