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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000759 |
AS PER AMENDMENT 10/24/96: To develop a domain/construct-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 (e.g., a standardized I.Q. score) versus discrete assessments (e.g., 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.
Condition |
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HIV Infections |
Study Type: | Observational |
Study Design: | Natural History |
Official Title: | Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials |
Estimated Enrollment: | 675 |
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 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.
Ages Eligible for Study: | 3 Months to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Participants must have:
AS PER AMENDMENT 10/24/96:
HIV-Infected Group: Documentation of HIV infection from a state-licensed lab as follows: Children > one month of age:
Children >= 18 months of age:
HIV-Exposed, Uninfected Group: Children < 18 months of age:
Children >= 18 months of age:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
AS PER AMENDMENT 10/24/96:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Study ID Numbers: | ACTG 188 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000759 |
Health Authority: | United States: Federal Government |
Central Nervous System Diseases Acquired Immunodeficiency Syndrome AIDS-Related Complex Peripheral Nervous System Diseases |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Peripheral Nervous System Diseases Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Central Nervous System Diseases AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |