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document
Triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV-1 ( Kesho Bora study ) : a randomised controlled trial . BACKGROUND Breastfeeding is essential for child health and development in low-resource settings but carries a significant risk of transmission of HIV-1 , especially in late stages of maternal disease . We aimed to assess the efficacy and safety of triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis in pregnant women infected with HIV . METHODS Pregnant women with WHO stage 1 , 2 , or 3 HIV-1 infection who had CD4 cell counts of 200-500 cells per μL were enrolled at five study sites in Burkina Faso , Kenya , and South Africa to start study treatment at 28-36 weeks ' gestation . Women were randomly assigned ( 1:1 ) by a computer generated random sequence to either triple antiretroviral prophylaxis ( a combination of 300 mg zidovudine , 150 mg lamivudine , and 400 mg lopinavir plus 100 mg ritonavir twice daily until cessation of breastfeeding to a maximum of 6·5 months post partum ) or zidovudine and single-dose nevirapine ( 300 mg zidovudine twice daily until delivery and a dose of 600 mg zidovudine plus 200 mg nevirapine at the onset of labour and , after a protocol amendment in December , 2006 , 1 week post-partum zidovudine 300 mg twice daily and lamivudine 150 mg twice daily ) . All infants received a 0·6 mL dose of nevirapine at birth and , from December , 2006 , 4 mg/kg twice daily of zidovudine for 1 week after birth . Patients and investigators were not masked to treatment . The primary endpoints were HIV-free infant survival at 6 weeks and 12 months ; HIV-free survival at 12 months in infants who were ever breastfed ; AIDS-free survival in mothers at 18 months ; and serious adverse events in mothers and babies . Analysis was by intention to treat . This trial is registered with Current Controlled Trials , ISRCTN71468401 . FINDINGS From June , 2005 , to August , 2008 , 882 women were enrolled , 824 of whom were randomised and gave birth to 805 singleton or first , liveborn infants . The cumulative rate of HIV transmission at 6 weeks was 3·3 % ( 95 % CI 1·9-5·6 % ) in the triple antiretroviral group compared with 5·0 % ( 3·3-7·7 % ) in the zidovudine and single-dose nevirapine group , and at 12 months was 5·4 % ( 3·6-8·1 % ) in the triple antiretroviral group compared with 9·5 % ( 7·0-12·9 % ) in the zidovudine and single-dose nevirapine group ( p=0·029 ) . The cumulative rate of HIV transmission or death at 12 months was 10·2 % ( 95 % CI 7·6-13·6 % ) in the triple antiretroviral group compared with 16·0 % ( 12·7-20·0 % ) in the zidovudine and single-dose nevirapine group ( p=0·017 ) . In infants whose mothers declared they intended to breastfeed , the cumulative rate of HIV transmission at 12 months was 5·6 % ( 95 % CI 3·4-8·9 % ) in the triple antiretroviral group compared with 10·7 % ( 7·6-14·8 % ) in the zidovudine and single-dose nevirapine group ( p=0·02 ) . AIDS-free survival in mothers at 18 months will be reported in a different publication . The incidence of laboratory and clinical serious adverse events in both mothers and their babies was similar between groups . INTERPRETATION Triple antiretroviral prophylaxis during pregnancy and breastfeeding is safe and reduces the risk of HIV transmission to infants . Revised WHO guidelines now recommend antiretroviral prophylaxis ( either to the mother or to the baby ) during breastfeeding if the mother is not already receiving antiretroviral treatment for her own health . FUNDING Agence nationale de recherches sur le sida et les hépatites virales , Department for International Development , European and Developing Countries Clinical Trials Partnership , Thrasher Research Fund , Belgian Directorate General for International Cooperation , Centers for Disease Control and Prevention , Eunice Kennedy Shriver National Institute of Child Health and Human Development , and UNDP/UNFPA/World Bank/WHO Special Programme of Research , Development and Research Training in Human Reproduction .
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Intervention_Pharmacological
Triple antiretroviral
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Intervention_Pharmacological
zidovudine
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Intervention_Pharmacological
nevirapine prophylaxis
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Outcome_Other
efficacy
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Outcome_Other
safety
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Participant_Condition
pregnant women infected with HIV .