Status:
COMPLETED
Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Kilimanjaro Christian Medical Centre, Tanzania
Kilimanjaro Clinical Research Institute
Conditions:
Efavirenz
Child Behavior
Eligibility:
All Genders
6-12 years
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. S...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03227653
Start Date
June 19 2017
End Date
December 31 2017
Last Update
July 10 2018
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Kilimanjaro Christian Medical Centre
Moshi, Kilimanjaro, Tanzania, 3010
2
Mawenzi Regional Hospital
Moshi, Kilimanjaro, Tanzania, 3054
3
Kibosho Hospital
Kibosho, Tanzania
4
Kiboroloni Dispensary
Moshi, Tanzania