CLINICAL AND LABORATORY CHARACTERISTICS OF A LARGE COHORT OF SYMPTOMATIC, HUMAN IMMUNODEFICIENCY VIRUS-INFECTED INFANTS AND CHILDREN

Background. A large cohort of antiretroviral therapy-naive, symptomati c, HIV-infected children were enrolled into a controlled therapeutic t rial (AIDS Clinical Trials Group Protocol 152), providing an opportuni ty to describe their clinical and laboratory characteristics and deter mine age-related distinctions. Methods. Study entry evaluations for 83 8 of 839 enrolled children were analyzed. Weight, head circumference ( if <30 months of age), neuroradiologic imaging of the head, developmen tal or cognitive status and neurologic examination were assessed. Labo ratory studies included hemoglobin, absolute neutrophil count, CD4 cel l count, serum amylase, alanine aminotransaminase, p24 antigen and HIV blood culture. Data were categorized by age (3 to <12 months, 12 to < 30 months, 30 months to 6 years and greater than or equal to 6 years). Results. Younger children had significantly higher rates of abnormali ties before antiretroviral therapy, especially factors relating to gro wth and neurologic or cognitive function. Lower CD4+ cell counts and p ercentages as well as a positive serum p24 antigen correlated with low er weight-for-age Z scores and developmental indices. Conclusions. The se data provide a description of the clinical characteristics of HIV-i nfected US children at the time antiretroviral therapy is initiated fo r HIV-related symptoms. The high rate of abnormalities of growth, deve lopment and cognitive ability that were observed in children <30 month s of age demonstrates that treatment strategies should be developed fo r earlier intervention.