TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral Therapy Failure and Resistance in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- resistance
研究概览
简要总结
This study will help identify which ARV candidates should be prioritized for pediatric use in resource-limited settings
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 18 years old
- •Have confirmed HIV infection
- •Are being switched to or treated with second-line ART. Second-line ART is defined as the second regimen with a major antiretroviral class switch. For example, a switch from an NNRTI-based to a PI-based regimen or vice versa
- •Caregivers give informed consent. Children will be asked to give assent if they know their HIV status and have reached the minimum age to give assent according to each site's institutional review board regulations
排除标准
- •Started mono- or dual- therapy as the first ART therapy
- •Failing first-line triple nucleoside reverse transcriptase inhibitor regimen
- •Are being switched to or treated with second-line ART without failure of first-line therapy (i.e., for toxicity)
- •Caregiver +/- child (if asked to give assent) refuses to participate in this study
- •Have not been enrolled in TApHOD
结局指标
主要结局
resistance
时间窗: week 72
To monitor for resistance development and resistance patterns in children failing second-line ART over 72 weeks
次要结局
- ARV drug levels(week 72)
- virologic failure(week 72)
- drug resistance(week 72)