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Nduati R, John G, Mbori-Ngacha D, et al. Effect of Breastfeeding and Formula Feeding on Transmission of HIV-1: A Randomized Clinical Trial. JAMA. 2000;283(9):1167–1174. doi:10.1001/jama.283.9.1167
Author Affiliations: Departments of Paediatrics (Drs Nduati, Mbori-Ngacha, and Onyango) and Medical Microbiology (Drs Ndinya-Achola and Bwayo and Mr Mwatha), University of Nairobi, Nairobi, Kenya; Departments of Epidemiology (Dr Kreiss), Medicine (Drs John and Kreiss), Biostatistics (Drs Richardson and Hughes), and Microbiology (Dr Overbaugh), University of Washington, Seattle.
Context Transmission of human immunodeficiency virus type 1 (HIV-1) is known
to occur through breastfeeding, but the magnitude of risk has not been precisely
defined. Whether breast milk HIV-1 transmission risk exceeds the potential
risk of formula-associated diarrheal mortality in developing countries is
Objectives To determine the frequency of breast milk transmission of HIV-1 and
to compare mortality rates and HIV-1–free survival in breastfed and
Design and Setting Randomized clinical trial conducted from November 1992 to July 1998
in antenatal clinics in Nairobi, Kenya, with a median follow-up period of
Participants Of 425 HIV-1–seropositive, antiretroviral-naive pregnant women
enrolled, 401 mother-infant pairs were included in the analysis of trial end
Interventions Mother-infant pairs were randomized to breastfeeding (n = 212) vs formula
feeding arms (n = 213).
Main Outcome Measures Infant HIV-1 infection and death during the first 2 years of life, compared
between the 2 intervention groups.
Results Compliance with the assigned feeding modality was 96% in the breastfeeding
arm and 70% in the formula arm (P<.001). Median
duration of breastfeeding was 17 months. Of the 401 infants included in the
analysis, 94% were followed up to HIV-1 infection or mortality end points:
83% for the HIV-1 infection end point and 93% to the mortality end point.
The cumulative probability of HIV-1 infection at 24 months was 36.7% (95%
confidence interval [CI], 29.4%-44.0%) in the breastfeeding arm and 20.5%
(95% CI, 14.0%-27.0%) in the formula arm (P = .001).
The estimated rate of breast milk transmission was 16.2% (95% CI, 6.5%-25.9%).
Forty-four percent of HIV-1 infection in the breastfeeding arm was attributable
to breast milk. Most breast milk transmission occurred early, with 75% of
the risk difference between the 2 arms occurring by 6 months, although transmission
continued throughout the duration of exposure. The 2-year mortality rates
in both arms were similar (breastfeeding arm, 24.4% [95% CI, 18.2%-30.7%]
vs formula feeding arm, 20.0% [95% CI, 14.4%-25.6%]; P
= .30). The rate of HIV-1–free survival at 2 years was significantly
lower in the breastfeeding arm than in the formula feeding arm (58.0% vs 70.0%,
respectively; P = .02).
Conclusions The frequency of breast milk transmission of HIV-1 was 16.2% in this
randomized clinical trial, and the majority of infections occurred early during
breastfeeding. The use of breast milk substitutes prevented 44% of infant
infections and was associated with significantly improved HIV-1–free
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