Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
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ClinicalTrials.gov Identifier: NCT00477308 |
Recruitment Status
:
Completed
First Posted
: May 23, 2007
Last Update Posted
: June 7, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Procedure: salvage therapy | Phase 4 |
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.
- No viral resistance
- Low grade resistance with or without clinical/ immunological failure
- 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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 participants |
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 |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |

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

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Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All children from HIV-NAT 013 phase I
Exclusion Criteria:
- No inform consent obtained

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477308
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 |
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 |
Additional Information:
Publications of Results:
Responsible Party: | Kiat Ruxrungtham, HIV-NAT |
ClinicalTrials.gov Identifier: | NCT00477308 History of Changes |
Other Study ID Numbers: |
HIV-NAT 013 phase II |
First Posted: | May 23, 2007 Key Record Dates |
Last Update Posted: | June 7, 2010 |
Last Verified: | June 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |