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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission
New England Journal of Medicine, Volume 359, No. 2, Year 2008
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Description
BACKGROUND Effective strategies are urgently needed to reduce mother-to-child transmission of human immunodef iciency virus type 1 (HIV-1) through breast-feeding in resource-limited settings. METHODS Women with HIV-1 infection who were breast-feeding infants were enrolled in a randomized, phase 3 trial in Blantyre, Malawi. At birth, the infants were randomly assigned to one of three regimens: single-dose nevirapine plus 1 week of zidovudine (control regimen) or the control regimen plus daily extended prophylaxis either with nevirapine (extended nevirapine) or with nevirapine plus zidovudine (extended dual prophylaxis) until the age of 14 weeks. Using Kaplan-Meier analyses, we assessed the risk of HIV-1 infection among infants who were HIV-1-negative on DNA polymerase-chain-reaction assay at birth. RESULT A mong 3016 in fants in the study, the control group had consistently higher rates of HIV-1 infection from the age of 6 weeks through 18 months. At 9 months, the estimated rate of HIV-1 infection (the primary end point) was 10.6% in the control group, as compared with 5.2% in the extended-nevirapine group (P<0.001) and 6.4% in the extended-dual-prophylaxis group (P = 0.002). There were no significant differences between the two extended-prophylaxis groups. The frequency of breast-feeding did not differ significantly among the study groups. Infants receiving extended dual prophylaxis had a significant increase in the number of adverse events (primarily neutropenia) that were deemed to be possibly related to a study drug. CONCLUSION Extended prophylaxis with nevirapine or with nevirapine and zidovudine for the first 14 weeks of life significantly reduced postnatal HIV-1 infection in 9-month-old infants. (ClinicalTrials.gov number, NCT00115648.) Copyright © 2008 Massachusetts Medical Society. All rights reserved.
Authors & Co-Authors
Kumwenda, Newton I.
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Hoover, Donald R.
United States, New Brunswick
Rutgers University–new Brunswick
Mofenson, Lynne M.
United States, Bethesda
National Institute of Child Health and Human Development Nichd
Thigpen, Michael C.
United States, Atlanta
Centers for Disease Control and Prevention
Kafulafula, George
Malawi, Zomba
University of Malawi
Li, Qing
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Mipando, Linda
United States, Baltimore
Johns Hopkins University
Nkanaunena, Kondwani
United States, Baltimore
Johns Hopkins University
Mebrahtu, Tsedal
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Bulterys, Marc G.
United States, Atlanta
Centers for Disease Control and Prevention
Fowler, Mary Glenn
United States, Baltimore
Johns Hopkins University
Taha, Taha E.
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Statistics
Citations: 391
Authors: 12
Affiliations: 6
Identifiers
Doi:
10.1056/NEJMoa0801941
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Genetics And Genomics
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Malawi
Participants Gender
Female