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Table 1. Large Observational Cohort Studies of Combination Antiretroviral Regimens on Risk for Mother-to-Child Transmission of HIV Infectiona

Study, Year (Reference) Location Interventions  Mother–Infant Pairs Enrolled, n Mother-to-Child Transmission Rate, % Cesarean Section Rate, % Breastfeeding Rate, % Internal Validity Rating
Italian Register for HIV Infection in Children, 200288 Italy No antiretroviral agents 2440 18.5 97.7 overall, 69.9 elective 2.8 overall Good
ZDV alone 743 6.1
>2 antiretroviral agents 248 1.6
Women and Infants' Transmission Study, 200282 US No antiretroviral agents 396 20.0 20.1 No infant was breastfed Good
ZDV alone 710 10.4 24.0
2 antiretroviral agents 186 3.8 33.8
HAART 250 1.2 44.4b
European Collaborative Study, 200589 Europe No antiretroviral agents 157 11.5 16 emergency, 61 elective overall 2 overall (through 2000) Good
HAART 918 1.2
French Perinatal Study, 200190 France ZDV alone (historical control group) 858 6.8 16 elective 0.3 Fair (used historical controls)
Lamivudine + ZDV from 32nd wk of pregnancy and to the child for 6 wk 437 1.6 22 elective 0.5

aHAART = highly active antiretroviral therapy; ZDV = zidovudine.
b.p=0.0001.

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