Study on Sophia HIV infected Children Cohort

Study on Sophia HIV infected Children Cohort - Sophia TREVI study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45152

Enrollment

Registered

2014-03-04

Start date

2013-09-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV associated Neurocognitive disease

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patiënt population: - Age 4 -20 - Dutch or Eglish speaking - HIV-infection - Currently under treatment at Sophie Children's Hospital;Siblings: - Age 4-20 - Dutch or English sprekend - No HIV-infection - Currently living in one household with patient - Living for at least 3 years with patient;Parents: - Dutch or English speaking - Care giver of patient for at least 3 years;Teachers - Dutch or English speaking - Elementary or high school teacher of patient

Exclusion criteria

Exclusion criteria: Patiënt population: - Younger than 3 years of age - Currently end of treatment at Sophia Children's Hospital - History of opportunistic infection of Central Nervous system - History of schizophrenia - History of chronic neurological disorders like epilepsy or multiple sclerosis - Affective disorder, reasonably causing cognitive deficits ;Siblings: - Age below 4 years or above 20 years - Not living in one household with patient - Living less than 3 years with patient in one household - History of opportunistic infection of Central Nervous system - History of schizophrenia - History of chronic neurological disorders like epilepsy or multiple sclerosis - Affective disorder, reasonably causing cognitive deficits ;Parents: - Not Dutch or English speaking;Teachers: - Not Dutch or English speaking

Design outcomes

Primary

Measure	Time frame
Interviews: Parents and children are invited to participate in the interview, which lasts about 25 minutes. The main topics discussed are school participation and neurocognitive functioning. In vitro analysis: A side from the routine virologic, immunologic and additional measurements, we want to draw 2 additional tubes. The following parameters are assessed: * tissue factor expression on monocytes * Endogeneous thrombine potential (ETP) * Fibrine 1+2 * Prothrombine time * van Willebrand factor * ATIII * Protein S * Plasmine-antiplasmine complex * D-dimer * Interleukin 6 * Circulating endothelial cells MRI MRI imaging will be performed on a 3.0 Tesla MR unit. The following structures will be assessed: white vs grey matter, hippocampus, cortical size and presence of focal leasions. Cortisol in hair Measurement of cortisol in hair is an validated technique since recently. We will take a small amount (10-100 hairs) from the back of the scalp. Amendment: Circulating Endothelial Cells.	—

Measure

Time frame

Interviews: Parents and children are invited to participate in the interview, which lasts about 25 minutes. The main topics discussed are school participation and neurocognitive functioning. In vitro analysis: A side from the routine virologic, immunologic and additional measurements, we want to draw 2 additional tubes. The following parameters are assessed: * tissue factor expression on monocytes * Endogeneous thrombine potential (ETP) * Fibrine 1+2 * Prothrombine time * van Willebrand factor * ATIII * Protein S * Plasmine-antiplasmine complex * D-dimer * Interleukin 6 * Circulating endothelial cells MRI MRI imaging will be performed on a 3.0 Tesla MR unit. The following structures will be assessed: white vs grey matter, hippocampus, cortical size and presence of focal leasions. Cortisol in hair Measurement of cortisol in hair is an validated technique since recently. We will take a small amount (10-100 hairs) from the back of the scalp. Amendment: Circulating Endothelial Cells.

—

Secondary

Measure	Time frame
not aplicable	—

Countries

Netherlands

Outcome results