Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

Conditions
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HIV Infections

Intervention / Treatment
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* Procedure: salvage therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All children from HIV-NAT 013 phase I Exclusion Criteria: No inform consent obtained

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: salvage therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: salvage therapy<br>Children with drug resistance were treated using the drug resistant profile | Procedure: salvage therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy |  | 1 time point (Cross Sectional Study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison outcome of children in the 3 groups, |  | 1 time point | 
| Changes of mutation in children within the 3 groups, and |  | 1 time point | 
| Effect of previously unreported mutations, minor and others, on treatment outcome |  | 1 time point | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV children, genotypic resistance, dual NRTIs, Salvage therapy, treatment outcome, Salvage therapy based on genotyping results, Treatment Failure