Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477308
• Other study ID #: HIV-NAT 013 phase II
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Est. completion date: April 2009

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• All children from HIV-NAT 013 phase I

Exclusion Criteria:

• No inform consent obtained

Related Conditions & MeSH terms

• HIV Infections

Intervention

Procedure:
• salvage therapy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Swiss Cohort

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy		1 time point (Cross Sectional Study)
Secondary	Comparison outcome of children in the 3 groups,		1 time point
Secondary	Changes of mutation in children within the 3 groups, and		1 time point
Secondary	Effect of previously unreported mutations, minor and others, on treatment outcome		1 time point

External Links

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