Published at www.nejm.org June 4, 2008 (10.1056/NEJMoa073788) |
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Published at www.nejm.org June 4, 2008 (10.1056/NEJMoa073788) |
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Background In low-resource settings, many programs recommend that women who are infected with the human immunodeficiency virus (HIV) stop breast-feeding early. We conducted a randomized trial to evaluate whether abrupt weaning at 4 months as compared with the standard practice has a net benefit for HIV-free survival of children.
Methods We enrolled 958 HIV-infected women and their infants in Lusaka, Zambia. All the women planned to breast-feed exclusively to 4 months; 481 were randomly assigned to a counseling program that encouraged abrupt weaning at 4 months, and 477 to a program that encouraged continued breast-feeding for as long as the women chose. The primary outcome was either HIV infection or death of the child by 24 months.
Results In the intervention group, 69.0% of the mothers stopped breast-feeding at 5 months or earlier; 68.8% of these women reported the completion of weaning in less than 2 days. In the control group, the median duration of breast-feeding was 16 months. In the overall cohort, there was no significant difference between the groups in the rate of HIV-free survival among the children; 68.4% and 64.0% survived to 24 months without HIV infection in the intervention and control groups, respectively (P=0.13). Among infants who were still being breast-fed and were not infected with HIV at 4 months, there was no significant difference between the groups in HIV-free survival at 24 months (83.9% and 80.7% in the intervention and control groups, respectively; P=0.27). Children who were infected with HIV by 4 months had a higher mortality by 24 months if they had been assigned to the intervention group than if they had been assigned to the control group (73.6% vs. 54.8%, P=0.007).
Conclusions Early, abrupt cessation of breast-feeding by HIV-infected women in a low-resource setting, such as Lusaka, Zambia, does not improve the rate of HIV-free survival among children born to HIV-infected mothers and is harmful to HIV-infected infants.(ClinicalTrials.gov number, NCT00310726
[ClinicalTrials.gov]
.)
Source Information
From the Gertrude H. Sergievsky Center and the Departments of Epidemiology (L.K., J.W.) and Biostatistics (W.-Y.T.), Mailman School of Public Health, Columbia University, New York; the Department of Pediatrics, Children's Hospital Los Angeles, University of Southern California, Los Angeles (G.M.A.); Lusaka District Health Management Team (M.S., C.V.), University Teaching Hospital, University of Zambia (C.K., M.M., P.K.), and U.S. Centers for Disease Control and Prevention Global AIDS Program (M.B.) — all in Lusaka, Zambia; and the Center for International Health and Development, Boston University School of Public Health, Boston (K.S., N.S., D.M.T.).
This article (10.1056/NEJMoa073788) was published at www.nejm.org on June 4, 2008. It will appear in the July 10 issue of the Journal.
Address reprint requests to Dr. Kuhn at the Sergievsky Center, Columbia University, 630 W. 168th St., New York, NY 10032, or at lk24{at}columbia.edu.
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