Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases
Study type: Observational

Summary: 
      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.
    

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 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.
    

Observational model: Natural History
Keywords: Central Nervous System Diseases; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Peripheral Nervous System Diseases