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Highly active antiretroviral therapy with efavirenz (EFV) has been prescribed to HIV-positive pregnant women in Rwanda (HIV status 1 and CD4 cell count > 350 cells/mm3) during the last trimester of pregnancy and for 6 months after delivery. The EFV concentrations in maternal plasma, breast milk and in newborns' plasma of 13 women and their children between 6 weeks and 6 months post partum are reported.Results show a mean EFV plasma concentration of 6.55 mg/L in maternal plasma, 3.51 mg/L in skim milk, and 0.85 mg/L in infant plasma. Significant linear correlations between maternal plasma and skim milk (r = 0.8666, P < 0.0001) and between skim milk and infant plasma (r = 0.6646, P < 0.02) were found, but no significant correlation was observed between maternal and infant plasma concentrations (P > 0.05).After 6 months of breast-feeding, no child out of the 13 had been infected with HIV and all had good psychomotor and growth development. Our results suggest that EFV may be an alternative to nevirapine (NVP) during the third trimester of pregnancy and during the breast-feeding period. Further studies on larger groups of newborns will be necessary to get a better understanding of possible prophylactic protection of the newborns by highly active antiretroviral therapy with EFV given to the mothers.