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Clinical Trials

MainTitle

Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

This study has been completed
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration

Collaborator
Swiss Cohort

Information provided by (Responsible Party)
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
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Procedure : salvage therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures

  • Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy [ Time Frame: 1 time point (Cross Sectional Study) ]
Secondary Outcome Measures:
  • 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 ]

Enrollment: 95
Study Start Date: January 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

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 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

Eligibility

Eligibility

Ages Eligible for Study: 1 Year to 18 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • All children from HIV-NAT 013 phase I


Exclusion Criteria:
  • No inform consent obtained

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477308

Locations

Thailand
Chulalongkorn Hospital
Bangkok, Thailand, 10330
Queen Sirikit National Institute of Child Health, Bangkok
Bangkok, Thailand, 10330
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Thailand, 10330

Sponsors and Collaborators

The HIV Netherlands Australia Thailand Research Collaboration
Swiss Cohort

Investigators

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
More Information

More Information

Additional Information:

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Responsible Party: Kiat Ruxrungtham, HIV-NAT  
ClinicalTrials.gov Identifier: NCT00477308   History of Changes  
Other Study ID Numbers: HIV-NAT 013 phase II  
Study First Received: May 20, 2007  
Last Updated: June 4, 2010  

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

HIV children
genotypic resistance
dual NRTIs
Salvage therapy
treatment outcome
Salvage therapy based on genotyping results
Treatment Failure

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.