Randomization
toxicity
HIV INFECTION
Eligible mother–infant pairs who consented for the postpartum component were randomized to 1 of the 2 arms: mART or iNVP at week 1 (day 6–14 postdelivery) continued until 18 months postdelivery or breastfeeding cessation, whichever occurred first unless stopped for toxicity, other medical reasons, or confirmed infant HIV infection. All infants received nevirapine during the first 6 weeks of life irrespective of the arms to which they were randomized. The infants in the mART arm received daily NVP only up to age 6 weeks as recommended by the World Health Organization (WHO) guidelines whereas the infants in the iNVP arm continued to receive NVP beyond 6 weeks of life through breastfeeding cessation or through 18 months postpartum, whichever came first unless it had to be stopped for infant HIV infection, toxicity, or other medical reasons. The preferred study–supplied mART regimen was twice daily protease inhibitors (PI) lopinavir/ritonavir (LPV/RTV) plus fixed-dose combination emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as the dual NRTI backbone. Combined ART regimens not provided by this study were allowed if they included at least 3 or more drugs from 2 or more antiretroviral classes.