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Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

This study has been completed.
Sponsor:
Collaborator:
Swiss Cohort
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00477308
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010

May 20, 2007
June 4, 2010
January 2006
April 2009   (final data collection date for primary outcome measure)
Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy [ Time Frame: 1 time point (Cross Sectional Study) ]
Same as current
Complete list of historical versions of study NCT00477308 on ClinicalTrials.gov Archive Site
  • Comparison outcome of children in the 3 groups, [ Time Frame: 1 time point ]
  • Changes of mutation in children within the 3 groups, and [ Time Frame: 1 time point ]
  • Effect of previously unreported mutations, minor and others, on treatment outcome [ Time Frame: 1 time point ]
1. Comparison outcome of children in the 3 groups, 2. Changes of mutation in children within the 3 groups, and 3. Effect of previously unreported mutations, minor and others, on treatment outcome [ Time Frame: 1 time point ]
Not Provided
Not Provided
 
Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

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.

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 physician's 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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
HIV Infections
Procedure: salvage therapy
Not Provided
Bunupuradah T, Suntarattiwong P, Li A, Sirivichayakul S, Pancharoen C, Boonrak P, Puthanakit T, Kerr SJ, Ruxrungtham K, Chotpitayasunondh T, Hirschel B, Ananworanich J; HIV-NAT 013 Study Team. Antiretroviral treatment outcome following genotyping in Thai children who failed dual nucleoside reverse transcriptase inhibitors. Int J Infect Dis. 2010 Apr;14(4):e311-6. Epub 2009 Aug 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All children from HIV-NAT 013 phase I

Exclusion Criteria:

  • No inform consent obtained
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00477308
HIV-NAT 013 phase II
Yes
Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
Swiss Cohort
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Principal Investigator: Tawee Chotpitayasunondh, MD Queen Sirikit National Institute of Child Health, Bangkok
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP