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Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV

NCT03227653 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2018-07-10

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania

    collaborator OTHER

  • Kilimanjaro Clinical Research Institute

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Grace Kinabo, MD, PhD · Kilimanjaro Christian Medical Centre

  • André van der Ven, MD, PhD · Radboud University Medical Center

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2017-12-31
Completion
2017-12-31
FDA Drug
Yes

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227653 on ClinicalTrials.gov