Background:  There are no published reports of the long-term safety and effectiveness of HAART for children and adolescents living in resource-limited settings, or of large cohorts of HIV-infected children and adolescents treated long-term (>48 weeks) with lopinavir (LPV)/ritonavir (RTV) -containing HAART. We evaluated the long-term outcomes of LPV/RTV-containing HAART in HIV-infected children and adolescents in a resource-limited setting.

Methods:  We studied an inception cohort of 414 HIV-infected children receiving LPV/RTV-containing HAART between November 2001 and August 2006 at the Romanian-American Children’s Center in Constanta, Romania. Safety and effectiveness were evaluated by the percentage of children remaining on treatment, rates of mortality, and changes in plasma HIV RNA concentrations and CD4⁺ lymphocyte counts.   

Results:  The study population consisted predominantly of ART-experienced older children and adolescents (mean age, 13 years; age range, 5 to 18 years) with advanced HIV disease. Treatment was well tolerated, with 337 (81%) children remaining on therapy after a median duration of >4 years:  37 deaths occurred, a death rate (1.2 to 3.3/100 patient-years) that compared favorably with prospectively collected historical data. The most recent on-treatment plasma HIV RNA concentration was <400 copies/mL in 192 (72%) of 265 children tested (median duration on treatment, >3 years).  The mean baseline CD4⁺ lymphocyte count was 292 cells/µL (n = 299); the mean change from baseline was >266 (n = 284), >317 (n = 260), >343 (n = 176), and >270 cells/µL (n = 121) after 1, 2, 3, and 4 years of treatment, respectively (for all comparisons, p <0.0001).

Conclusions:  HAART can be administered safely and effectively to children and adolescents in resource-limited settings. LPV/RTV-containing HAART is a safe, effective, and durable treatment option for ART-experienced older children and adolescents with advanced HIV disease.