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Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00477308
Enrollment
95
Registered
2007-05-23
Start date
2006-01-31
Completion date
2009-04-30
Last updated
2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

Brief summary

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

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

Interventions

Sponsors

Swiss Cohort
CollaboratorUNKNOWN
The HIV Netherlands Australia Thailand Research Collaboration
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

salvage therapy

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* All children from HIV-NAT 013 phase I

Exclusion criteria

* No inform consent obtained

Design outcomes

Primary

MeasureTime frame
Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy1 time point (Cross Sectional Study)

Secondary

MeasureTime frame
Comparison outcome of children in the 3 groups,1 time point
Changes of mutation in children within the 3 groups, and1 time point
Effect of previously unreported mutations, minor and others, on treatment outcome1 time point

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026