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Completed

NCT Number: NCT00477308

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn Hospital, Bangkok, Thailand

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All children from HIV-NAT 013 phase I

Exclusion criteria

  • No inform consent obtained

Treatment and study plan

salvage therapy

Procedure

Primary outcomes

  1. Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy

    Time frame: 1 time point (Cross Sectional Study)

Secondary outcomes

  1. Comparison outcome of children in the 3 groups,

    Time frame: 1 time point

  2. Changes of mutation in children within the 3 groups, and

    Time frame: 1 time point

  3. Effect of previously unreported mutations, minor and others, on treatment outcome

    Time frame: 1 time point

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Swiss Cohort

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 23, 2007
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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