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EfavirenzNCT03227653

Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV

An observational study of Efavirenz and Child Behavior, run by Radboud University Medical Center at 6 sites in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Efavirenz, Child Behavior, Cognitive Symptom
What is being tested?
Efavirenz, Nevirapine and Lopinavir-Ritonavir Drug Combination
How many people
144 participants
Where
6 sitesTanzania
Study dates
19 Jun 2017to 31 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Tanzanian children (6-12 years) living with HIV and receiving cART

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

Tanzania6 sites

  • Kibosho Hospital

    Kibosho

  • Kilimanjaro Christian Medical Centre

    Moshi, Kilimanjaro, 3010

  • Mawenzi Regional Hospital

    Moshi, Kilimanjaro, 3054

  • Kiboroloni Dispensary

    Moshi

  • Majengo Health Centre

    Moshi

  • Pasua Health Centre

    Moshi

Other trials in Tanzania

About this study

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

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.

Read the 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. .

Being tested
Efavirenz, Nevirapine, Lopinavir-Ritonavir Drug Combination
Keywords
Efavirenz, Child Behavior, Cognition, Medication Adherence, Drug-Related Side Effects
Medical subject headings
Child Behavior, Neurobehavioral Manifestations, Medication Adherence, Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EfavirenzDrug

    Also called Efavirenz-group

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

  • NevirapineDrug

    Also called Non-efavirenz group

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

  • Lopinavir-Ritonavir Drug CombinationDrug

    Also called Non-efavirenz group

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

Study groups in NCT03227653
Study groupRoleWhat they receive
EfavirenzChildren using efavirenz-based cART for at least 6 months
Receives: Drug: Efavirenz
Non-efavirenzChildren using non-efavirenz-based cART (nevirapine or Lopinavir-Ritonavir Drug Combination) for at least 6 months.
Receives: Drug: Nevirapine; Drug: Lopinavir-Ritonavir Drug Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychological symptoms: competence and psychopathology (internalizing/externalizing symptoms)

    Neuropsychological symptoms will be assessed using the Swahili version of the Child Behavior Checklist for 6-18 years (CBCL6-18)

    Measured: At day of inclusion

Secondary outcomes (3)

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

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

    Measured: At day of inclusion

  2. Cognitive functioning - working memory

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

    Measured: At day of inclusion

  3. Treatment adherence

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

    Measured: At day of inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start19 Jun 2017
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03227653
Sponsor's protocol ID
EFV Kids
Status last verified
Jul 2018
First submitted
18 Jul 2017
Last updated
10 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van de Wijer L, Schellekens AFA, Burger DM, Homberg JR, de Mast Q, van der Ven AJAM. Rethinking the risk-benefit ratio of efavirenz in HIV-infected children. Lancet Infect Dis. 2016 May;16(5):e76-e81. doi: 10.1016/S1473-3099(16)00117-1. Epub 2016 Apr 18.

    PubMed 27599655

  • Mothapo KM, Schellekens A, van Crevel R, Keuter M, Grintjes-Huisman K, Koopmans P, van der Ven A. Improvement of Depression and Anxiety After Discontinuation of Long- Term Efavirenz Treatment. CNS Neurol Disord Drug Targets. 2015;14(6):811-8. doi: 10.2174/1871527314666150325235847.

    PubMed 25808896

  • Van de Wijer L, Kinabo GD, Mchaile DN, de Mast Q, Schellekens AFA, van der Ven AJAM. Safety Evaluation of Efavirenz in Children: Don't Forget the Central Nervous System. Clin Infect Dis. 2018 Mar 19;66(7):1150. doi: 10.1093/cid/cix926. No abstract available.

    PubMed 29088326

  • Van de Wijer L, Mchaile DN, de Mast Q, Mmbaga BT, Rommelse NNJ, Duinmaijer A, van der Ven AJAM, Schellekens AFA, Kinabo GD. Neuropsychiatric symptoms in Tanzanian HIV-infected children receiving long-term efavirenz treatment: a multicentre, cross-sectional, observational study. Lancet HIV. 2019 Apr;6(4):e250-e258. doi: 10.1016/S2352-3018(18)30329-1. Epub 2019 Feb 12.

    PubMed 30770324

Questions about this trial

What is this clinical trial studying?

An observational study of Efavirenz and Child Behavior, run by Radboud University Medical Center at 6 sites in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropsychological symptoms: competence and psychopathology (internalizing/externalizing symptoms) (time frame: At day of inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03227653, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.

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