Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV

Radboud University Medical Center

Status: Completed

Conditions: Drug-Related Side Effects and Adverse Reactions; Medication Adherence; Child Behavior; Efavirenz; Cognitive Symptom

Treatments: Drug: Efavirenz; Drug: Lopinavir-Ritonavir Drug Combination; Drug: Nevirapine

Study type: Observational

Funder types: Other

Identifiers

NCT03227653

EFV Kids

Details and patient eligibility

About

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.

Full 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. .

Enrollment: 144 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

144 participants in 2 patient groups

Efavirenz

Description:

Children using efavirenz-based cART for at least 6 months

Treatment:

Drug: Efavirenz

Non-efavirenz

Description:

Children using non-efavirenz-based cART (nevirapine or Lopinavir-Ritonavir Drug Combination) for at least 6 months.

Treatment:

Drug: Nevirapine

Drug: Lopinavir-Ritonavir Drug Combination