Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000759
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
Status:
COMPLETED
Status Verified Date:
1998-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AS PER AMENDMENT 102496 To develop a domainconstruct-driven neuropsychological and neurological battery Scaling of instruments to allow measurement of functions from infancy to early adulthood establish reliability and validity of the new instruments developed for the NIMH Neurodevelopmental Battery Downward extension of cognitive domains into infancy and early childhood To describe and compare outcomes when assessing level of development versus rate of change Describe and compare the outcomes from a global assessment of neurodevelopment eg a standardized IQ score versus discrete assessments eg functional domains such as motor or language skills Develop guidelines for multicultural neuropsychological and neurological assessment within a clinical trials design Describe the nature of impaired developmental abilities and course of the disease in infants and children
The assessment of children who sustain central nervous system CNS insult requires approaches that differ in several ways from adult-based assessment The rapid changes that occur in the developing CNS as well as in behavior reflect underlying processes of growth and development
The assessment of children who sustain central nervous system CNS insult requires approaches that differ in several ways from adult-based assessment The rapid changes that occur in the developing CNS as well as in behavior reflect underlying processes of growth and development
Detailed Description:
The assessment of children who sustain central nervous system CNS insult requires approaches that differ in several ways from adult-based assessment The rapid changes that occur in the developing CNS as well as in behavior reflect underlying processes of growth and development
This study will be conducted as a nested substudy within ACTG 152 AS PER AMENDMENT 102497 ACTG 188 was originally a nested study within ACTG 152 a three-arm clinical drug trial but due to recruitment limitations expanded to include other protocol and non-protocol children with HIV-1 infection
It will include 225 HIV-infected patients from ACTG 152 as well as an additional 450 non-infected participants recruited for two comparison groups one consisting of seronegative infants and children with perinatal exposure to HIV and a second group without perinatal exposure to HIV AS PER AMENDMENT 102496 Patients in the HIV-unexposed and uninfected group are discontinued from the study and remaining patients are reassigned to two new age groups 3 months to 41 months and 30 days or 42 months to 9 years 11 months 30 days Patients 33 months or older but less than 42 months are discontinued from the study those patients less than 33 months at the time of enrollment are graduated from the study at the age of 42 months
A neurological assessment battery will evaluate the following domains growth sensory tone motor posture locomotion hand use deep tendon reflexes abnormal movements language and behavior Participants will be asked to do different kinds of activities such as talking listening and drawing and to play games that involve walking jumping concentration and memory All participants will be assessed at clinic visits and followed for 72 weeks AS PER AMENDMENT 102397 A modified version of the neurological battery will be discontinued from interim follow-up evaluations and will be administered one last time as part of the exit evaluation
This study will be conducted as a nested substudy within ACTG 152 AS PER AMENDMENT 102497 ACTG 188 was originally a nested study within ACTG 152 a three-arm clinical drug trial but due to recruitment limitations expanded to include other protocol and non-protocol children with HIV-1 infection
It will include 225 HIV-infected patients from ACTG 152 as well as an additional 450 non-infected participants recruited for two comparison groups one consisting of seronegative infants and children with perinatal exposure to HIV and a second group without perinatal exposure to HIV AS PER AMENDMENT 102496 Patients in the HIV-unexposed and uninfected group are discontinued from the study and remaining patients are reassigned to two new age groups 3 months to 41 months and 30 days or 42 months to 9 years 11 months 30 days Patients 33 months or older but less than 42 months are discontinued from the study those patients less than 33 months at the time of enrollment are graduated from the study at the age of 42 months
A neurological assessment battery will evaluate the following domains growth sensory tone motor posture locomotion hand use deep tendon reflexes abnormal movements language and behavior Participants will be asked to do different kinds of activities such as talking listening and drawing and to play games that involve walking jumping concentration and memory All participants will be assessed at clinic visits and followed for 72 weeks AS PER AMENDMENT 102397 A modified version of the neurological battery will be discontinued from interim follow-up evaluations and will be administered one last time as part of the exit evaluation
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: