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

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.