Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

July 15, 2020 updated by: The HIV Netherlands Australia Thailand Research Collaboration

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital
      • Bangkok, Thailand, 10330
        • Queen Sirikit National Institute of Child Health, Bangkok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All children from HIV-NAT 013 phase I

Exclusion Criteria:

  • No inform consent obtained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Swiss Cohort

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

May 20, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (Estimate)

May 23, 2007

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT 013 phase II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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