Document Detail


Three postpartum antiretroviral regimens to prevent intrapartum HIV infection.
MedLine Citation:
PMID:  22716975     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants.
METHODS: Within 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth.
RESULTS: A total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan-Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intrapartum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P=0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P=0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P=0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P<0.001 for both comparisons with the other groups).
CONCLUSIONS: In neonates whose mothers did not receive ART during pregnancy, prophylaxis with a two- or three-drug ART regimen is superior to zidovudine alone for the prevention of intrapartum HIV transmission; the two-drug regimen has less toxicity than the three-drug regimen. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD] and others; ClinicalTrials.gov number, NCT00099359.).
Authors:
Karin Nielsen-Saines; D Heather Watts; Valdilea G Veloso; Yvonne J Bryson; Esau C Joao; Jose Henrique Pilotto; Glenda Gray; Gerhard Theron; Breno Santos; Rosana Fonseca; Regis Kreitchmann; Jorge Pinto; Marisa M Mussi-Pinhata; Mariana Ceriotto; Daisy Machado; James Bethel; Marisa G Morgado; Ruth Dickover; Margaret Camarca; Mark Mirochnick; George Siberry; Beatriz Grinsztejn; Ronaldo I Moreira; Francisco I Bastos; Jiahong Xu; Jack Moye; Lynne M Mofenson;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  The New England journal of medicine     Volume:  366     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-06-21     Completed Date:  2012-06-26     Revised Date:  2013-07-12    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2368-79     Citation Subset:  AIM; IM    
Affiliation:
Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA 90095, USA. knielsen@mednet.ucla.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00099359
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MeSH Terms
Descriptor/Qualifier:
Anti-Retroviral Agents / adverse effects,  therapeutic use*
Drug Resistance, Viral
Drug Therapy, Combination / adverse effects
Female
HIV Infections / mortality,  prevention & control*,  transmission
HIV-1*
Humans
Infant Formula
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Kaplan-Meier Estimate
Lamivudine / adverse effects,  therapeutic use*
Male
Nelfinavir / adverse effects,  therapeutic use*
Nevirapine / adverse effects,  therapeutic use*
Postpartum Period
Pregnancy
Pregnancy Complications, Infectious
Zidovudine / adverse effects,  therapeutic use*
Grant Support
ID/Acronym/Agency:
AI068632/AI/NIAID NIH HHS; HHSN267200800001C//PHS HHS; N01-HD-8-0001/HD/NICHD NIH HHS; U01 AI047986/AI/NIAID NIH HHS; U01 AI047986/AI/NIAID NIH HHS; U01 AI068632/AI/NIAID NIH HHS; U01 AI068632/AI/NIAID NIH HHS; UM1 AI068632/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Retroviral Agents; 129618-40-2/Nevirapine; 134678-17-4/Lamivudine; 159989-64-7/Nelfinavir; 30516-87-1/Zidovudine
Investigator
Investigator/Affiliation:
Edgardo Szyld / ; Silvia Marzo / ; Flavia Faleiro Ferreira / ; Fabiana Kakehasi / ; Rita Lira / ; Carla Franceschini de Fraga Rita Lira / ; Debora Fernandes Coelho / ; Alberto Sanseverino / ; Luis Carlos Ribeiro / ; M Leticia Santos Cruz / ; Ezequias Martins / ; Jacqueline Anita de Menezes / ; Luisa Andrea Torres Salgado / ; Ana Valeria Cordovil / ; Andréa Gouveia / ; Priscila Mazzucanti / ; Jorge Eurico Ribeiro / ; Geraldo Duarte / ; Adriana Aparecida Tiraboschi Barbaro / ; Carolina Sales Vieira / ; Regina Succi / ; Mark Cotton / ; Jeanne Louw / ; Elke Maritz / ; Sarita Lalsab / ; Shini Legoete / ; James Alasdair McIntyre / ; Mandisa Nyati / ; Allison Agwu / ; Jean Anderson / ; Joan Bess / ; Jonathan Ellen / ; Todd Noletto / ; Nancy Hutton / ; Carol Delany / ; Robert M Lawrence / ; Chas Griggs / ; Mobeen Rathore / ; Kathleen Thoma / ; Michelle Tucker / ; Audra Deveikis / ; Susan Marks / ; Linda Bettica / ; James M Oleske / ; Midnela Acevedo Flores / ; Elvia Pérez / ; Marilia Santini de Oliveira / ; Monica Derrico / ; Valéria Ribeiro / ; Thiago Torres / ; Emmanuel Aluko / ; Yolanda Bertucci / ; Jennifer Bryant / ; Patty Chen / ; Barbara Driver / ; Ruby Duston / ; Adriana Ferreira / ; Priya Guyadeen / ; Sarah Howell / ; Marsha Johnson / ; Linda Kaufman / ; Naomi Leshabane / ; Lilya Meyerson / ; Rita Patel / ; Lubima Petrova / ; Georgine Price / ; Susan Raitt / ; Scott Watson / ; Yiling Xu / ; Eunice Yu / ; Jennifer Read / ; Elizabeth Smith / ; Sheryl Zwerski /
Comments/Corrections

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