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NCT Number: NCT03227653

Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV

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.

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Key information

Conditions

Efavirenz Behavior Chemically-Induced Disorders Child Behavior Cognitive Symptom Drug-Related Side Effects and Adverse Reactions Health Behavior Medication Adherence Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kilimanjaro Christian Medical Centre, Moshi, Kilimanjaro, Tanzania

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About this study

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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efavirenz

Drug

Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS

Other names: Efavirenz-group

Nevirapine

Drug

Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS

Other names: Non-efavirenz group

Lopinavir-Ritonavir Drug Combination

Drug

Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS

Other names: Non-efavirenz group

Primary outcomes

  1. 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

  1. Cognitive functioning - non-verbal cognitive ability (general intelligence)

    Time frame: At day of inclusion

    Non-verbal cognitive ability will be assessed using the Raven's Progressive Matrices

  2. Cognitive functioning - working memory

    Time frame: At day of inclusion

    Working memory will be assessed using the Wechsler Intelligence Scale for Children (WISC-III) Digit Span Test

  3. Treatment adherence

    Time frame: At day of inclusion

    Treatment adherence will be measured using an adherence questionnaire, adapted from the PENTA 16 trial (permission obtained from the author prof. Giaquinto)

Other outcomes

  1. Central nervous system symptoms

    Time frame: At day of inclusion

    The presence of central nervous system symptoms (yes/no) in the week prior to study visit will be assessed using a checklist composed of symptoms that have been linked to efavirenz in literature.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania
  • Kilimanjaro Clinical Research Institute

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2017
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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