Clinical trial NCT00477308: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV children
genotypic resistance
dual NRTIs
Salvage therapy
treatment outcome
Salvage therapy based on genotyping results
Treatment Failure
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Swiss Cohort
First posted: 2007-05-23
Enrollment: 95
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: salvage therapy
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

* All children from HIV-NAT 013 phase I

Exclusion Criteria:

* No inform consent obtained

Primary outcomes:
measure: Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy
timeFrame: 1 time point (Cross Sectional Study)
Secondary outcomes:
measure: Comparison outcome of children in the 3 groups,
timeFrame: 1 time point
measure: Changes of mutation in children within the 3 groups, and
timeFrame: 1 time point
measure: Effect of previously unreported mutations, minor and others, on treatment outcome
timeFrame: 1 time point
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health, Bangkok
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Sirikit National Institute of Child Health, Bangkok
name: Tawee Chotpitayasunondh, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.