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The state of the nervous system, psychology and eyes of HIV-infected children in comparison to healthy children.


- candidate number15118
- NTR NumberNTR4074
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jul-2013
- Secondary IDsNOVICE 
- Public TitleThe state of the nervous system, psychology and eyes of HIV-infected children in comparison to healthy children.
- Scientific TitleNeurological, visual and neurocognitive performance in pediatric HIV‐1‐infected patients as compared to healthy controls.
- ACRONYMNOVICE
- hypothesisHIV-infection and antiretroviral therapy use may lead to a diminished neurological and neurocognitive performance in HIV-infected children.
- Healt Condition(s) or Problem(s) studiedHIV infection, Neuropathy , AIDS, Children, Co-morbidity, Antiretroviral therapy (ART)
- Inclusion criteriaConfirmed HIV-1 infection (cases only)
8-18 years of age
- Exclusion criteriaTrauma >30 minutes
Intracranial malignancy
Severe psychiatric disorders
MRI contra-indications
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 28-dec-2012
- planned closingdate1-feb-2014
- Target number of participants80
- InterventionsNone (observational study)
- Primary outcomeNeuropsychological performance
MRI/MRS- white matter abnormalities, cerebral perfusion, metabolite concentrations
Ophthalmological assessment outcomes
Optical Coherence Tomography outcomes
- Secondary outcomeCerebrospinal fluid/blood: neuro-damage markers, immune activation markers
Antiretroviral therapy concentration in CSF/Blood
- TimepointsCross-sectional
- Trial web sitewww.hetklikt.nu/novice
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S Cohen
- CONTACT for SCIENTIFIC QUERIESDr. D. Pajkrt
- Sponsor/Initiator University of Amsterdam (UVA)
- Funding
(Source(s) of Monetary or Material Support)
Steun Emma fonds
- PublicationsN/A
- Brief summaryationale: Before the era of combined antiretroviral therapy (cART), perinatally infected HIV‐positive children frequently presented with serious neurological dysfunctioning (prevalence varying from 30%‐50%), including HIV‐encephalopathy, as characterized by impaired brain growth and acquired microcephaly, symmetrical motor deficits and loss of or failure to attain developmental milestones1. Early neuroimaging studies of HIVencephalopathy using computed tomography (CT) demonstrated cerebral atrophy, calcifications in the basal ganglia and white matter changes2. Since HIV‐infected children are being treated with cART, the incidence of HIV‐encephalopathy has decreased while in the meantime neuro‐imaging abnormalities shown by these conventional neuroimaging techniques have improved1. Children can present with other neurologic disorders such as seizures, headaches and neurocognitive impairments (e.g. learning‐, behavioural‐, and motor deficits)3. The etiology of this neurocognitive impairment is complex and, most likely, not purely biologically determined. Environmental factors, such as home environment and socioeconomic status (SES), may play a confounding role in cognitive development4. In our patient group, the SES is generally lower than in the average population. Comparative data on neurological and neurocognitive findings between HIV‐infected and healthy controls with equal SES and living within similar environments are lacking. Since neurological and neurocognitive disorders cannot be diagnosed until they are clinically obvious, the availability of objective, reliable, non‐invasive markers may offer great advantages in assessing early central nervous system (CNS) involvement in HIV‐positive children. Standardized neuropsychological assessment (NPA) and several advanced neuroimaging tests as well as ophthalmological measurements are available to study the neurological, neurocognitive and ophthalmological disorders in HIV‐positive children. In addition, biochemical tests and measurement of cART concentration levels in cerebrospinal fluid (CSF) and blood, and combining these results with the earlier mentioned NPA, neuroimaging and ophthalmological tests, will provide more insight in the pathophysiology of CNS involvement of HIV and its clinical consequences.
- Main changes (audit trail)
- RECORD12-jul-2013 - 1-aug-2013


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