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Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

Primary Purpose

HIV Infections

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

salvage therapy

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV children, genotypic resistance, dual NRTIs, Salvage therapy, treatment outcome, Salvage therapy based on genotyping results, Treatment Failure

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All children from HIV-NAT 013 phase I

Exclusion Criteria:

No inform consent obtained

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

salvage therapy

Arm Description

Children with drug resistance were treated using the drug resistant profile

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison outcome of children in the 3 groups,

Changes of mutation in children within the 3 groups, and

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

Full Information

NCT ID

NCT00477308

First Posted

May 20, 2007

Last Updated

July 15, 2020

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Swiss Cohort

1. Study Identification

Unique Protocol Identification Number

NCT00477308

Brief Title

Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Swiss Cohort

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV children, genotypic resistance, dual NRTIs, Salvage therapy, treatment outcome, Salvage therapy based on genotyping results, Treatment Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

salvage therapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

salvage therapy

Arm Type

Other

Arm Description

Children with drug resistance were treated using the drug resistant profile

Intervention Type

Procedure

Intervention Name(s)

salvage therapy

Primary Outcome Measure Information:

Title

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

Time Frame

1 time point (Cross Sectional Study)

Secondary Outcome Measure Information:

Title

Comparison outcome of children in the 3 groups,

Time Frame

1 time point

Title

Changes of mutation in children within the 3 groups, and

Time Frame

1 time point

Title

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

Time Frame

1 time point

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All children from HIV-NAT 013 phase I Exclusion Criteria: No inform consent obtained

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kiat Ruxrungtham, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tawee Chotpitayasunondh, MD

Organizational Affiliation

Queen Sirikit National Institute of Child Health, Bangkok

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chulalongkorn Hospital

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Queen Sirikit National Institute of Child Health, Bangkok

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

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

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

19699673

Citation

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.

Results Reference

result

Links:

URL

http://www.hivnat.org

Description

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

Learn more about this trial

Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

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