Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Procedure: salvage therapy	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	95 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs
Study Start Date :	January 2006
Actual Primary Completion Date :	April 2009
Actual Study Completion Date :	April 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	1 Year to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• All children from HIV-NAT 013 phase I

Exclusion Criteria:

• No inform consent obtained

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

The HIV Netherlands Australia Thailand Research Collaboration

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Publications of Results:

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.

Responsible Party:	Kiat Ruxrungtham, HIV-NAT
ClinicalTrials.gov Identifier:	NCT00477308 History of Changes
Other Study ID Numbers:	HIV-NAT 013 phase II
First Posted:	May 23, 2007
Last Update Posted:	June 7, 2010
Last Verified:	June 2010

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

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

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases	Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases