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Neurologische en cognitieve ontwikkeling bij kinderen die vanaf de geboorte hiv ge´nfecteerd zijn


- candidate number27318
- NTR NumberNTR7000
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mei-2017
- Secondary IDs2016-173 METC
- Public TitleNeurologische en cognitieve ontwikkeling bij kinderen die vanaf de geboorte hiv ge´nfecteerd zijn
- Scientific TitleNeurological, visual and neurocognitive performance in pediatric HIV-1- infected patients as compared to healthy controls
- ACRONYMNOVICE II
- hypothesis
- Healt Condition(s) or Problem(s) studiedHIV infection
- Inclusion criteriaChildren between 8-22 years of age, perinatally infected with hiv.
Together with healthy controls, machted with the infected group for gender, age, socioeconomic status and ethnicity.
- Exclusion criteriachronic neurological disorders like epilepsy, intracerebral neoplasms and psychiatric disorders
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 23-mei-2017
- planned closingdate
- Target number of participants100
- InterventionsNone
- Primary outcomedifference in neurocognitive functioning compared to baseline visit (NOVICE I)
- Secondary outcome
- TimepointsSecond measurement after 4-5 years. These measurements are cross sectional.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES M. Hof, van den
- CONTACT for SCIENTIFIC QUERIES M. Hof, van den
- Sponsor/Initiator Aidsfonds
- Funding
(Source(s) of Monetary or Material Support)
Aidsfonds
- Publications
- Brief summaryDespite combination antiretroviral therapy (cART), perinatally HIV (PHIV)-infected children present with significant neurodevelopmental delays and cognitive impairments. The pathogenesis may partially differ from that in adults, as HIV does not only cause direct injury to the CNS, but may also impede the development of the pediatric brain. As we have recently shown, manifestations of HIV in the pediatric central nervous system (CNS) include brain volume reduction and white matter lesions, as well as widespread microstructural changes, such as poorer white matter integrity and alterations in cerebral metabolites. Evidence implies significant roles for ongoing neuroinflammation, vascular dysfunction and hypercoagulability. Investigations combining neuropsychological assessment, multimodal neuroimaging and laboratory evaluation of inflammatory and neurodegenerative markers could greatly increase our understanding and improve treatment strategies. Longitudinal research will be crucial to observe and understand mechanisms underlying these long-term consequences of CNS exposure to HIV and cART as PHIV-infected survive into adulthood. In this study we will evaluate neurological and cognitive outcomes in a case-control cohort of PHIV infected children and sex, ethnicity and socioeconomic status matched healthy controls at an interval period of four years. We will investigate potential mechanisms and factors (such as inflammatory and neuronal biomarkers) that may influence these CNS functions.
- Main changes (audit trail)Ontbrekende informatie niet aangeleverd door onderzoeker.
- RECORD24-mei-2017 - 8-feb-2018


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