Effects of early, abrupt weaning on HIV-free survival of children in Zambia.
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.)
Kuhn
Louise
L
Gertrude H. Sergievsky Center and the Department of Epidemiology, Mailman School of Public Health, Columbia University, New York 10032, USA. lk24@columbia.edu
Aldrovandi
Grace M
GM
Sinkala
Moses
M
Kankasa
Chipepo
C
Semrau
Katherine
K
Mwiya
Mwiya
M
Kasonde
Prisca
P
Scott
Nancy
N
Vwalika
Cheswa
C
Walter
Jan
J
Bulterys
Marc
M
Tsai
Wei-Yann
WY
Thea
Donald M
DM
D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D001942:Breast Feeding / Q000706:statistics & numerical data; D018572:Disease-Free Survival; D005260:Female; D006678:HIV; D015658:HIV Infections / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control / Q000635:transmission*; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D018655:Lymphocyte Count; D008297:Male; D010349:Patient Compliance; D018709:Statistics, Nonparametric; D014886:Weaning; D015024:Zambia / Q000453:epidemiology
D044966:Anti-Retroviral Agents