In Reply: Dr Bulterys raises concern about
comparability of the 2 arms of our trial because of the differential HIV-1
infection rates at birth. The most likely explanation was low specificity
of the HIV-1 poymerase chain reaction test on cord blood combined with a high
risk of breast milk transmission during the first 6 weeks of life (the next
scheduled testing time). The likelihood that a positive test at birth would
be followed by a second positive test result was higher in the breastfeeding
arm than the formula arm (50% vs 18%) because of ongoing exposure to HIV-1
through breastfeeding. The timing for such infections was defined by the first
positive result (even though the cord blood result may have been a false positive),
hence a higher apparent infection rate at birth. We developed statistical
methods to adjust for this problem.
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