Treatment Failure of Second-line ART in Asian HIV-infected Children Clinical Trial
Official title:
TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral Therapy Failure and Resistance in Children
This study will help identify which ARV candidates should be prioritized for pediatric use in resource-limited settings
Children in resource-limited settings are increasing experiencing treatment failure, as
defined by virologic, immunologic, and/or clinical criteria. There are few studies of HIV
resistance mutations in children failing first line NNRTI therapy in resource limited
settings. The emergence of treatment failure and drug resistance in children on ART
emphasizes the urgency for developing evidence-based second-line and salvage treatment
strategies. Pediatric treatment is complicated by a number of factors, including having
fewer numbers of ARVs approved by drug safety agencies and the lack of pediatric
formulations. This further shortens the list of available second-line ARVs as compared to
adults.
Despite the growing number of children on second-line therapy worldwide, there are limited
data on efficacy of second-line PI therapy in children after NRTI-NNRTI failure. There are
currently no options for third-line/salvage regimens for children in resource-limited
settings. New drugs and drug classes are approved for use in children by the US FDA but are
not routinely available outside of high-income settings.
Also, there are no data on the resistance patterns of children failing second-line therapy
in resource-limited settings to guide clinical management and ARV procurement. Clinicians
need evidence-based guidelines for how to manage children with treatment failure, and access
to the drugs necessary to construct potent and durable third-line regimens.
TASER-P is a longitudinal observational cohort study to monitor for treatment failure to
second-line ART in Asian children.
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Observational Model: Cohort, Time Perspective: Prospective