Search / Trial NCT00000759

Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Central Nervous System Diseases Acquired Immunodeficiency Syndrome Aids Related Complex Peripheral Nervous System Diseases

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 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 in...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Participants must have:
  • 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:
  • Documentation of current or prior enrollment in an investigational drug therapy or other research protocol in which the protocol inclusion criteria specify HIV infection OR laboratory evidence of vertically transmitted HIV infection as demonstrated on two separate peripheral blood samples by either a positive viral culture (blood or cerebrospinal fluid) OR detectably serum p24 antigen OR positive HIV-DNA PCR.
  • 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
  • Co-existing Condition:
  • 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.

Attachments

readout_NCT00000759_2024-03-02.pdf

4.5 MB

NCT00000759_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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