An interventional study of salvage therapy in HIV Infections, sponsored by The HIV Netherlands Australia Thailand Research Collaboration. Completed at 3 sites in Thailand. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2020-07-17.
Sponsored by The HIV Netherlands Australia Thailand Research Collaboration · Not applicable, Interventional, and Treatment
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.
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.
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
4,259 studies on the registry are indexed under HIV Infections; 241 are open to participants now.
This study's enrollment of 95 is above the median of 83 across 3,252 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →The HIV Netherlands Australia Thailand Research Collaboration is the lead sponsor of 59 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children with drug resistance were treated using the drug resistant profile
Procedure: salvage therapy
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
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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The HIV Netherlands Australia Thailand Research Collaboration