Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

Resource links provided by NLM:


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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children from HIV-NAT 013 phase I

Exclusion Criteria:

  • No inform consent obtained
  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

Additional Information:
Publications:
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
Health Authority: Thailand: Ethical Committee

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014