Neuropsychiatric Adverse Effects of Efavirenz in Children Living With HIV in Kilimanjaro, Tanzania
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 144
- Locations
- 6
- Primary Endpoint
- Neuropsychological symptoms: competence and psychopathology (internalizing/externalizing symptoms)
Study Overview
Brief Summary
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.
Detailed Description
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. .
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Efavirenz
Children using efavirenz-based cART for at least 6 months
Intervention: Efavirenz (Drug)
Non-efavirenz
Children using non-efavirenz-based cART (nevirapine or Lopinavir-Ritonavir Drug Combination) for at least 6 months.
Intervention: Nevirapine (Drug)
Non-efavirenz
Children using non-efavirenz-based cART (nevirapine or Lopinavir-Ritonavir Drug Combination) for at least 6 months.
Intervention: Lopinavir-Ritonavir Drug Combination (Drug)
Outcomes
Primary Outcomes
Neuropsychological symptoms: competence and psychopathology (internalizing/externalizing symptoms)
Time Frame: At day of inclusion
Neuropsychological symptoms will be assessed using the Swahili version of the Child Behavior Checklist for 6-18 years (CBCL6-18)
Secondary Outcomes
- 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)