Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

NCT ID: NCT00477308

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-04-30

Brief Summary

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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

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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

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

salvage therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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salvage therapy

Children with drug resistance were treated using the drug resistant profile

Group Type OTHER

salvage therapy

Intervention Type PROCEDURE

Interventions

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salvage therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All children from HIV-NAT 013 phase I

Exclusion Criteria

* No inform consent obtained
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Cohort

UNKNOWN

Sponsor Role collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kiat Ruxrungtham, MD

Role: PRINCIPAL_INVESTIGATOR

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Tawee Chotpitayasunondh, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Sirikit National Institute of Child Health, Bangkok

Locations

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Chulalongkorn Hospital

Bangkok, , Thailand

Site Status

Queen Sirikit National Institute of Child Health, Bangkok

Bangkok, , Thailand

Site Status

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Bunupuradah T, Suntarattiwong P, Li A, Sirivichayakul S, Pancharoen C, Boonrak P, Puthanakit T, Kerr SJ, Ruxrungtham K, Chotpitayasunondh T, Hirschel B, Ananworanich J; HIV-NAT 013 Study Team. Antiretroviral treatment outcome following genotyping in Thai children who failed dual nucleoside reverse transcriptase inhibitors. Int J Infect Dis. 2010 Apr;14(4):e311-6. doi: 10.1016/j.ijid.2009.05.017. Epub 2009 Aug 21.

Reference Type RESULT
PMID: 19699673 (View on PubMed)

Related Links

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http://www.hivnat.org

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Other Identifiers

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HIV-NAT 013 phase II

Identifier Type: -

Identifier Source: org_study_id

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