Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
NCT ID: NCT00000759
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
675 participants
OBSERVATIONAL
Brief Summary
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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
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This study will be conducted as a nested substudy within ACTG 152. AS PER AMENDMENT 10/24/97: 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 10/24/96: 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 10/23/97: 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.
Conditions
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Study Design
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NATURAL_HISTORY
Eligibility Criteria
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Inclusion Criteria
AS PER AMENDMENT 10/24/96:
* Signed, informed consent from a parent or legal guardian for patients under 18 years of age.
HIV-Infected Group: Documentation of HIV infection from a state-licensed lab as follows: Children \> one month of age:
Children \>= 18 months of age:
* Fulfillment of above criteria OR \>= 2 positive tests for HIV antibody (two different specimens) determined by a federally-licensed test kit for detection of antibody, confirmed by an independent supplemental test.
* Documentation of presumption of maternal HIV infection at or prior to the birth of the child.
HIV-Exposed, Uninfected Group: Children \< 18 months of age:
* At least two negative tests for direct detection of HIV (viral culture and/or antigen detection and/or PCR assay and normal immunologic function.
Children \>= 18 months of age:
* Negative serological test by an FDA-licensed test kit for detection of HIV antibody performed on a specimen obtained at \>= 18 months of age.
* Documentation of presence of maternal HIV infection at or prior to the birth of the child.
Exclusion Criteria
Patients with the following conditions are excluded:
AS PER AMENDMENT 10/24/96:
* Central nervous system (CNS) disorders including poorly controlled seizure disorder while on anticonvulsant therapy, evidence of neuroimaging abnormality resulting from a traumatic brain injury or major congenital malformations associated with CNS dysfunction.
* Genetic diseases including:
* inborn errors of metabolism, inherited genetic diseases that would compromise CNS function, chromosomal disorder that would compromise CNS function, cystic fibrosis, muscular dystrophy, sickle cell anemia.
* Juvenile onset diabetes.
* Organ transplant recipients.
* Deafness or blindness.
Concurrent Medication:
Excluded:
* Intrathecal or intraventricular chemotherapy.
Concurrent Treatment:
Excluded:
* Cranial or spinal radiation therapy.
Patients with the following prior conditions are excluded:
* Traumatic brain injury with loss of consciousness of \> 24 hours and/or skull fracture.
* Prematurity including:
* intraventricular hemorrhage \> grade 2, requirement for mechanical ventilation for \> 28 days, seizures or another perinatal brain injury history including history of hydrocephaly.
Prior Medication:
Excluded:
* Intrathecal or intraventricular chemotherapy.
Prior Treatment:
Excluded:
* Cranial or spinal radiation therapy.
3 Months
8 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Wilson B
Role: STUDY_CHAIR
Fletcher J
Role: STUDY_CHAIR
Belman A
Role: STUDY_CHAIR
Locations
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Mount Sinai Med Ctr
New York, New York, United States
Countries
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Other Identifiers
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ACTG 188
Identifier Type: -
Identifier Source: org_study_id