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Objective   To assess the impact on immunological, virological and metabolic parameters of replacing protease inhibitors (PIs) with efavirenz and replacing stavudine with tenofovir in HIV-infected children.Methods   A 48-week prospective evaluation of 28 HIV-infected children, with stable undetectable HIV-1 loads, who were taking highly active antiretroviral therapy (HAART) containing lamivudine, stavudine and a PI. Individuals were randomized to switch PI to efavirenz and stavudine to tenofovir at baseline (Group 1) or at week 24 (Group 2). Patient assessment included: clinical evaluation, viral load, CD4 +  T-cell count, fasting blood levels and urine samples.Results   All individuals maintained HIV RNA &lt;50 copies/ml and unchanged CD4 +  T-cell count through week 48. In Group 1 individuals, a significant decrease in cholesterol ( P&lt;0.05), cholesterol:high-density lipoprotein (HDL) ratio ( P&lt;0.01) and triglycerides ( P&lt;0.05) was observed 24 and 48 weeks after the switch of HAART. The percentage of Group 1 children with increased cholesterol and triglycerides markedly decreased over the study period (from 43% to 0% and from 36% to 7%, respectively). In Group 2 individuals, unchanged lipids in the 24 weeks prior to the switch of HAART and a significant improvement on cholesterol ( P&lt;0.05), cholesterol:HDL ratio ( P&lt;0.01) and triglycerides ( P&lt;0.05) were observed 24 weeks after the switch of HAART. The percentage of Group 2 children with increased cholesterol and triglycerides markedly decreased 24 weeks after the switch of HAART (from 46% to 7% and from 54% to 0%, respectively). Proteinuria and glucosuria were not detected in any individual. The mean values of serum creatinine, serum phosphorus, serum bicarbonate, estimated glomerular filtration rate, urinary microalbumin/creati-nine, α-1-microglobulin/creatinine ratio and maximal tubular phosphate reabsorption remained unchanged in both groups.Conclusions   In HIV-infected children, switching PI to efavirenz and stavudine to tenofovir is virologically and immunologically safe, is not associated with renal impairment and provides a significant improvement in lipid profile.

Improvement in Dyslipidaemia after Switching Stavudine to Tenofovir and Replacing Protease Inhibitors with Efavirenz in HIV-Infected Children