Neuropsychiatric Adverse Effects of Efavirenz in Children Living With HIV in Kilimanjaro, Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 6
- 主要终点
- Neuropsychological symptoms: competence and psychopathology (internalizing/externalizing symptoms)
研究概览
简要总结
Efavirenz is among the preferred antiretroviral drugs for HIV-infected children. Increasing evidence shows that central nervous system side-effects in adults are more common than previously thought. Still, reliable data in children are lacking. As HIV-infected children nowadays have a prospect of reaching adulthood, there is an urgent need to identify potential long-term central nervous system side-effects, interfering with neurodevelopment and psychosocial maturation. Using validated tools, we assessed (1) competence (social/activities/school) and psychopathology (internalizing/externalizing problems), (2) cognitive performance (intelligence and working memory), and (3) adherence in Tanzanian children on an efavirenz or non-efavirenz based regimen
In this cross-sectional observational study the investigators will examine neuropsychiatric and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination antiretroviral therapy (cART) with or without efavirenz.
详细描述
In this cross-sectional observational study, we include HIV-infected children (6-12 years) on cART for ≥ 6 months, with viral loads ≤ 1000 copies/ml in Kilimanjaro Region, Tanzania. Psychopathology and competence will be assessed using the Child Behaviour Checklist. Cognitive performance will be assessed using the Raven's Coloured Progressive Matrices and the digit span test. Non-adherence is defined as any reported missed doses over the previous 3 days or <100% adherence since the last clinical visit. Analysis of covariance and logistic regression models will be used to assess differences between groups. .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6 until 12 years
- •HIV seropositive
- •Using cART, with or without efavirenz, for at least 6 months
- •Registered patient at one of the participating centres
- •In the presence of at least one parent or caregiver who is part if the child's life/upbringing
排除标准
- •Switch of cART regimen in the last 6 months
- •History of brain injury, mental health and cognitive impairment before starting cART
- •HIV RNA >1000 copies/mL within the past year
- •Any AIDS-defining illness or acute illness (e.g. fever, lowered consciousness, dehydration) at time of inclusion
- •Children with parent(s) or caregiver(s) not wanting or not able to give informed consent
研究组 & 干预措施
Efavirenz
Children using efavirenz-based cART for at least 6 months
干预措施: Efavirenz (Drug)
Non-efavirenz
Children using non-efavirenz-based cART (nevirapine or Lopinavir-Ritonavir Drug Combination) for at least 6 months.
干预措施: Nevirapine (Drug)
Non-efavirenz
Children using non-efavirenz-based cART (nevirapine or Lopinavir-Ritonavir Drug Combination) for at least 6 months.
干预措施: Lopinavir-Ritonavir Drug Combination (Drug)
结局指标
主要结局
Neuropsychological symptoms: competence and psychopathology (internalizing/externalizing symptoms)
时间窗: At day of inclusion
Neuropsychological symptoms will be assessed using the Swahili version of the Child Behavior Checklist for 6-18 years (CBCL6-18)
次要结局
- Cognitive functioning - non-verbal cognitive ability (general intelligence)(At day of inclusion)
- Cognitive functioning - working memory(At day of inclusion)
- Treatment adherence(At day of inclusion)