ABSTRACT. Objective. To examine beneficial or detrimental effects of protease inhibitor (PI)-containing antiretroviral regimens on height and weight growth in children with human immunodeficiency virus (HIV) infection.Methods. A prospective cohort study was conducted of 906 HIV-infected children, from pediatric research clinics in the United States, who were between 3 months and 18 years of age and who had height and weight assessed in 1995 (before introduction of PIs in this population) and at least once more through 1999. Changes in age-and gender-adjusted height and weight growth associated with PI use were assessed.Results. Compared with a healthy reference population, children were more affected in height (mean z score: ؊0.90 [18th percentile]) than in weight (mean z score: ؊0.42 [34th percentile]) at baseline (1995). Two thirds of children received at least 1 PI during 1996 to 1999. In the multivariate mixed effects regression models adjusted for baseline log 10 CD4 cell count, baseline age, gender, and race/ethnicity, the use of PIs was associated with per-year gains of 0.13 z scores in height and 0.05 z scores in weight relative to the expected growth with non-PIcontaining regimens (eg, after 1 year of PI use, a representative 6-year-old boy in our study would be approximately 0.7 cm taller and 0.1 kg heavier than if he had not received PIs). No significant differential effects of PIs on height or weight growth according to specific agents or children's sociodemographic or clinical characteristics were found.Conclusions. Although the use of PI-containing regimens was not associated with growth retardation, it was associated with only small annual increments in height and weight growth in HIV-infected children. Pediatrics 2001;108(4). URL: http://www.pediatrics.org/cgi/content/ full/108/4/e72; HIV-1, protease inhibitor, growth, children.ABBREVIATIONS. PI, protease inhibitor; HIV, human immunodeficiency virus; PACTG, Pediatric AIDS Clinical Trials Group; HAZ, height-for-age-and-gender z score; WAZ, weight-for-ageand-gender z score. P rotease inhibitors (PIs) have been used increasingly in the treatment of human immunodeficiency virus (HIV)-infected children since the mid-1990s. However, little is known about the longterm effects of PI-containing combination antiretroviral therapies on height and weight growth in pediatric populations. HIV-infected children fall behind HIV-uninfected children who are born to HIVinfected mothers in age-and gender-appropriate height and weight in the first few years of life. [1][2][3] Studies that examined the effect of zidovudine on height and weight gain in HIV-infected children were limited by sample size and produced mixed results. 2,4 Some small clinical studies [5][6][7][8] suggested that PI treatments may have beneficial effects on weight and/or height growth in HIV-infected children, but other studies found no improvements in growth associated with the use of PI-containing regimens. 9 -11 The hope is that PI treatments may reverse some of the negative effects of HIV ...