Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Procedure: salvage therapy

• Registration Number: NCT00477308
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-05-20
• Study First Submitted QC: 2007-05-22
• Study First Posted: 2007-05-23
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• All children from HIV-NAT 013 phase I

Exclusion Criteria

• No inform consent obtained

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
salvage therapy	salvage therapy	Children with drug resistance were treated using the drug resistant profile

Primary Outcome Measures

Name	Time	Method
Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy	1 time point (Cross Sectional Study)

Secondary Outcome Measures

Name	Time	Method
Effect of previously unreported mutations, minor and others, on treatment outcome	1 time point
Comparison outcome of children in the 3 groups,	1 time point
Changes of mutation in children within the 3 groups, and	1 time point

Trial Locations

Locations (3)

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT); 🇹🇭 Bangkok, Thailand

Queen Sirikit National Institute of Child Health, Bangkok; 🇹🇭 Bangkok, Thailand