The randomized aspect of our study was limited to women with CD4+ cell counts of 200 cells per cubic millimeter or more, and the median HIV-1 RNA level was lower than that in many treatment settings. Therefore, extrapolation of the results of our randomized comparisons to women with lower CD4+ cell counts may be limited. Finally, our study was not intended to answer some important policy questions regarding the prevention of mother-to-child transmission, including whether the use of HAART in women is superior to shortcourse zidovudine with prolonged nevirapine prophylaxis in infants during breast-feeding among women with higher CD4+ cell counts, and whether the use of HAART in women who breast-feed for more than 6 months remains protective.