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Ritonavir may be effective and well-tolerated in children infected with HIV. Ritonavir is a protease inhibitor drug used to treat HIV-infected adults. Researchers evaluated the safety and effectiveness of ritonavir in 48 children, aged 6 months to 14.4 years. Ritonavir therapy resulted in an average increase in the CD4 white blood cell count of 79 cells per cubic millimeter, and a decrease in blood levels of the virus. Gastrointestinal complaints were the most common side-effects. Ritonavir may be an appropriate component of combination drug therapy in pediatric HIV disease., Background. Ritonavir, a potent antiretroviral protease inhibitor, has been approved for the treatment of adults and children with human immunodeficiency virus (HIV) infection. In a phase I/II study, we assessed the safety, tolerability, and pharmacokinetic profile of the oral solution of ritonavir in HIV-infected children and studied the preliminary antiviral and clinical effects. Methods. HIV-infected children between 6 months and 18 years of age were eligible. Four dose levels of ritonavir oral solution (250, 300, 350, and 400 mg/[m.sup.2] given every 12 hours) were evaluated in two age groups ([is less than or equal to] 2 years, [is greater than] 2 years). Ritonavir was administered alone for the first 12 weeks and then in combination with zidovudine and/or didanosine. Clinical and laboratory parameters were monitored every 2 to 4 weeks. Results. A total of 48 children (median age, 7.7 years; range, 0.5 to 14.4 years) were included in this analysis. Dose-related nausea, diarrhea, and abdominal pain were the most common toxicities and resulted in discontinuation of ritonavir in 7 children. Ritonavir was well absorbed at all dose levels, and plasma concentrations reached a peak 2 to 4 hours after a dose. CD4 cells counts increased by a median of 79 cells/[mm.sup.3] after 4 weeks of monotherapy and were maintained throughout the study. Plasma HIV RNA decreased by 1 to 2 [log.sub.10] copies/mL within 4 to 8 weeks of ritonavir monotherapy, and this level was sustained in patients enrolled at the highest dose level of 400 mg/[m.sup.2] for the 24-week period. Conclusions. The oral solution of ritonavir has potent antiretroviral activity as a single agent and is relatively well tolerated by children when administered alone or in combination with zidovudine or didanosine. Pediatrics 1998;101:335-343, protease inhibitor, child, HIV-1, CD4 cells, HIV RNA, pharmacokinetics., As of December 1996, [is greater than] 7600 children have been diagnosed with acquired immunodeficiency syndrome (AIDS) in the United States.[1] Approved treatment options for human immunodeficiency virus (HIV)-infected children [...]