Journal article
Maternal or Infant Antiretroviral Drugs to Reduce HIV-1 Transmission
The New England journal of medicine, Vol.362(24), pp.2271-2281
06/17/2010
DOI: 10.1056/NEJMoa0911486
PMCID: PMC3440865
PMID: 20554982
Abstract
Background
We evaluated the efficacy of a maternal triple-drug antiretroviral regimen or infant nevirapine prophylaxis for 28 weeks during breast-feeding to reduce postnatal transmission of human immunodeficiency virus type 1 (HIV-1) in Malawi.
Methods
We randomly assigned 2369 HIV-1-positive, breast-feeding mothers with a CD4+ lymphocyte count of at least 250 cells per cubic millimeter and their infants to receive a maternal antiretroviral regimen, infant nevirapine, or no extended postnatal antiretroviral regimen (control group). All mothers and infants received perinatal prophylaxis with single-dose nevirapine and 1 week of zidovudine plus lamivudine. We used the Kaplan-Meier method to estimate the cumulative risk of HIV-1 transmission or death by 28 weeks among infants who were HIV-1-negative 2 weeks after birth. Rates were compared with the use of the log-rank test.
Results
Among mother-infant pairs, 5.0% of infants were HIV-1-positive at 2 weeks of life. The estimated risk of HIV-1 transmission between 2 and 28 weeks was higher in the control group (5.7%) than in either the maternal-regimen group (2.9%, P = 0.009) or the infant-regimen group (1.7%, P<0.001). The estimated risk of infant HIV-1 infection or death between 2 and 28 weeks was 7.0% in the control group, 4.1% in the maternal-regimen group (P = 0.02), and 2.6% in the infant-regimen group (P<0.001). The proportion of women with neutropenia was higher among those receiving the antiretroviral regimen (6.2%) than among those in either the nevirapine group (2.6%) or the control group (2.3%). Among infants receiving nevirapine, 1.9% had a hypersensitivity reaction.
Conclusions
The use of either a maternal antiretroviral regimen or infant nevirapine for 28 weeks was effective in reducing HIV-1 transmission during breast-feeding. (ClinicalTrials.gov number, NCT00164736.)
Details
- Title: Subtitle
- Maternal or Infant Antiretroviral Drugs to Reduce HIV-1 Transmission
- Creators
- Charles S. Chasela - Univ N Carolina Project, Lilongwe, MalawiMichael G. Hudgens - University of North Carolina at Chapel HillDenise J. Jamieson - Ctr Dis Control & Prevent, Atlanta, GA USADumbani Kayira - Univ N Carolina Project, Lilongwe, MalawiMina C. Hosseinipour - Univ N Carolina Project, Lilongwe, MalawiAthena P. Kourtis - Ctr Dis Control & Prevent, Atlanta, GA USAFrancis Martinson - Univ N Carolina Project, Lilongwe, MalawiGerald Tegha - Univ N Carolina Project, Lilongwe, MalawiRodney J. Knight - Principia CollegeYusuf I. Ahmed - Ctr Dis Control & Prevent, Atlanta, GA USADeborah D. Kamwendo - Univ N Carolina Project, Lilongwe, MalawiIrving F. Hoffman - University of North Carolina at Chapel HillSascha R. Ellington - Ctr Dis Control & Prevent, Atlanta, GA USAZebrone Kacheche - Univ N Carolina Project, Lilongwe, MalawiAlice Soko - Univ N Carolina Project, Lilongwe, MalawiJeffrey B. Wiener - Ctr Dis Control & Prevent, Atlanta, GA USASusan A. Fiscus - University of North Carolina at Chapel HillPeter Kazembe - University of North Carolina at Chapel HillInnocent A. Mofolo - Univ N Carolina Project, Lilongwe, MalawiMaggie Chigwenembe - Univ N Carolina Project, Lilongwe, MalawiDorothy S. Sichali - Univ N Carolina Project, Lilongwe, MalawiCharles M. van der Horst - University of North Carolina at Chapel HillBreastfeeding, Antiretrovirals and Nutrition (BAN) Study Team
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.362(24), pp.2271-2281
- DOI
- 10.1056/NEJMoa0911486
- PMID
- 20554982
- PMCID
- PMC3440865
- NLM abbreviation
- N Engl J Med
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Publisher
- Massachusetts Medical Soc
- Number of pages
- 11
- Grant note
- U48DP000059 / NATIONAL CENTER FOR CHRONIC DISEASE PREV AND HEALTH PROMO; United States Department of Health & Human Services; Centers for Disease Control & Prevention - USA Bristol-Myers Squibb Elizabeth Glaser Pediatric AIDS Foundation DHHS/NIH/FIC 2-D43 Tw01039-06 / NIH; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA U.S. Agency for International Development; United States Agency for International Development (USAID) D43TW001039 / FOGARTY INTERNATIONAL CENTER; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Fogarty International Center (FIC) SIP 13-01 U48-CCU409660-09; SIP 26-04 U48-DP000059-01 / Centers for Disease Control and Prevention; United States Department of Health & Human Services; Centers for Disease Control & Prevention - USA Johnson Johnson; Johnson & Johnson; Johnson & Johnson USA P30AI050410 / NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) GlaxoSmithKline Abbott Laboratories P30-AI50410 / University of North Carolina Center for AIDS Research World Food Program National Institute of Allergy and Infectious Diseases; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) Roche Pharmaceuticals; Roche Holding Malawi Ministry of Health and Population Boehringer Ingelheim United Nations Children's Fund R24HD050924 / EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
- Language
- English
- Date published
- 06/17/2010
- Academic Unit
- Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984446454802771
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