Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
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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 |
- 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 ]
| 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) |
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
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All children from HIV-NAT 013 phase I
Exclusion Criteria:
- No inform consent obtained
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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 |
ClinicalTrials.gov processed this record on March 01, 2015