Neurologic and neurocognitive impairment and brain injury
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Cases: Perinatally infected with HIV Controls: HIV-unexposed and/or uninfected Age: between 8-18 years old and furthermore adults >=18 years old can be included if previously included in NOVICE I or II cohort and matched according age, sex, SES and if possible adoption status
Exclusion criteria
Exclusion criteria: Neurological disorders: intracranial malignancy, history of traumatic brain injury with loss of consciousness > 30 minutes Current severe psychiatric disorders (e.g. major depression) MRI contra-indications (e.g. implanted active devices such as cardiac pacemakers, implantable defibrillator or medication pumps, or metal splinters in eye, brain or lungs, claustrophobia, dental braces are allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main primary outcome measures and variables are first of all evaluating neurological, cognitive and psychosocial outcomes and change after a 10-year interval in children, adolescents and (if included in previous NOVICE studies) young adults with perinatally acquired HIV (PHIV) on adequate treatment as compared to HIV-negative controls matched for age, gender, ethnic background, and socioeconomic status. Outcome measures and variables are measured by neuropsychological assessment (NPA) and different MRI sequences. Secondly, to find associations between structural neurological and cognitive outcomes, defined as MRI abnormalities, psychosocial and cognitive development, as well as associations between plasma biomarkers, faecal microbiome and structural neurological and cognitive outcomes in children, adolescents and young adults with PHIV compared to HIV negative controls. Furthermore, identifying difference in biomarker expression between PHIV children and HIV-negative controls to further investigate and better understand the underlying pathophysiological mechanism and clinical course of HIV-associated neurocognitive disorders despite adequate treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary outcome measures are the examination of metabolic and cardiovascular risk profiles after a 10-year interval in children, adolescents and (if included in previous NOVICE studies) young adults with perinatally infected HIV (PHIV) on adequate treatment as compared to HIV-negative controls matched for age, gender, ethnic background, and socioeconomic status. In addition, to identify associations between plasma biomarkers, fecal microbiome and cardiovascular/metabolic risk profile and combination antiretroviral therapy in children and adolescents with PHIV to further investigate the underlying pathophysiological mechanism and clinical course of HIV-associated neurocognitive disorders despite adequate treatment. | — |
Countries
Netherlands
Outcome results
None listed