NCT03227653

Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV

Neuropsychiatric Adverse Effects of Efavirenz in Children Living With HIV in Kilimanjaro, Tanzania

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 144 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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. .

Conditions

• Efavirenz
• Child Behavior
• Cognitive Symptom
• Medication Adherence
• Drug-Related Side Effects and Adverse Reactions

Interventions

Type	Name	Description
DRUG	Efavirenz	Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
DRUG	Nevirapine	Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
DRUG	Lopinavir-Ritonavir Drug Combination	Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS

Timeline

• Start date: 2017-06-19
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2017-07-24
• Last updated: 2018-07-10

Locations

6 sites across 1 country: Tanzania

Regulatory

• FDA-regulated drug study