Document Detail


Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial.
MedLine Citation:
PMID:  22541418     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In resource-limited settings where no safe alternative to breastfeeding exists, WHO recommends that antiretroviral prophylaxis be given to either HIV-infected mothers or infants throughout breastfeeding. We assessed the effect of 28 weeks of maternal or infant antiretroviral prophylaxis on postnatal HIV infection at 48 weeks.
METHODS: The Breastfeeding, Antiretrovirals, and Nutrition (BAN) Study was undertaken in Lilongwe, Malawi, between April 21, 2004, and Jan 28, 2010. 2369 HIV-infected breastfeeding mothers with a CD4 count of 250 cells per μL or more and their newborn babies were randomly assigned with a variable-block design to one of three, 28-week regimens: maternal triple antiretroviral (n=849); daily infant nevirapine (n=852); or control (n=668). Patients and local clinical staff were not masked to treatment allocation, but other study investigators were. All mothers and infants received one dose of nevirapine (mother 200 mg; infant 2 mg/kg) and 7 days of zidovudine (mother 300 mg; infants 2 mg/kg) and lamivudine (mothers 150 mg; infants 4 mg/kg) twice a day. Mothers were advised to wean between 24 weeks and 28 weeks after birth. The primary endpoint was HIV infection by 48 weeks in infants who were not infected at 2 weeks and in all infants randomly assigned with censoring at loss to follow-up. This trial is registered with ClinicalTrials.gov, number NCT00164736.
FINDINGS: 676 mother-infant pairs completed follow-up to 48 weeks or reached an endpoint in the maternal-antiretroviral group, 680 in the infant-nevirapine group, and 542 in the control group. By 32 weeks post partum, 96% of women in the intervention groups and 88% of those in the control group reported no breastfeeding since their 28-week visit. 30 infants in the maternal-antiretroviral group, 25 in the infant-nevirapine group, and 38 in the control group became HIV infected between 2 weeks and 48 weeks of life; 28 (30%) infections occurred after 28 weeks (nine in maternal-antiretroviral, 13 in infant-nevirapine, and six in control groups). The cumulative risk of HIV-1 transmission by 48 weeks was significantly higher in the control group (7%, 95% CI 5-9) than in the maternal-antiretroviral (4%, 3-6; p=0·0273) or the infant-nevirapine (4%, 2-5; p=0·0027) groups. The rate of serious adverse events in infants was significantly higher during 29-48 weeks than during the intervention phase (1·1 [95% CI 1·0-1·2] vs 0·7 [0·7-0·8] per 100 person-weeks; p<0·0001), with increased risk of diarrhoea, malaria, growth faltering, tuberculosis, and death. Nine women died between 2 weeks and 48 weeks post partum (one in maternal-antiretroviral group, two in infant-nevirapine group, six in control group).
INTERPRETATION: In resource-limited settings where no suitable alternative to breastfeeding is available, antiretroviral prophylaxis given to mothers or infants might decrease HIV transmission. Weaning at 6 months might increase infant morbidity.
FUNDING: US Centers for Disease Control and Prevention.
Authors:
Denise J Jamieson; Charles S Chasela; Michael G Hudgens; Caroline C King; Athena P Kourtis; Dumbani Kayira; Mina C Hosseinipour; Deborah D Kamwendo; Sascha R Ellington; Jeffrey B Wiener; Susan A Fiscus; Gerald Tegha; Innocent A Mofolo; Dorothy S Sichali; Linda S Adair; Rodney J Knight; Francis Martinson; Zebrone Kacheche; Alice Soko; Irving Hoffman; Charles van der Horst;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, American Recovery and Reinvestment Act; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.     Date:  2012-04-26
Journal Detail:
Title:  Lancet     Volume:  379     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-07-03     Completed Date:  2012-08-01     Revised Date:  2014-04-08    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  2449-58     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Elsevier Ltd. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00164736
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Retroviral Agents / administration & dosage*
Breast Feeding
Female
Follow-Up Studies
HIV Infections / drug therapy,  prevention & control*,  transmission
HIV-1*
Humans
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Lamivudine / administration & dosage
Nevirapine / administration & dosage
Pregnancy
Young Adult
Zidovudine / administration & dosage
Grant Support
ID/Acronym/Agency:
D43 TW001039/TW/FIC NIH HHS; FIC 2-D43 TW01039-06/TW/FIC NIH HHS; P30 AI050410/AI/NIAID NIH HHS; P30-AI50410/AI/NIAID NIH HHS; R24 HD050924/HD/NICHD NIH HHS; R24 TW007988/TW/FIC NIH HHS; SIP 13-01 U48-CCU409660-09//PHS HHS; SIP 22-09 U48-DP001944-01/DP/NCCDPHP CDC HHS; SIP 26-04 U48-DP000059-01/DP/NCCDPHP CDC HHS
Chemical
Reg. No./Substance:
0/Anti-Retroviral Agents; 2T8Q726O95/Lamivudine; 4B9XT59T7S/Zidovudine; 99DK7FVK1H/Nevirapine
Investigator
Investigator/Affiliation:
Linda Adair / ; Yusuf Ahmed / ; Mounir Ait-Khaled / ; Sandra Albrecht / ; Shrikant Bangdiwala / ; Ronald Bayer / ; Margaret Bentley / ; Brian Bramson / ; Emily Bobrow / ; Nicola Boyle / ; Sal Butera / ; Charles Chasela / ; Charity Chavula / ; Joseph Chimerang'ambe / ; Maggie Chigwenembe / ; Maria Chikasema / ; Norah Chikhungu / ; David Chilongozi / ; Grace Chiudzu / ; Lenesi Chome / ; Anne Cole / ; Amanda Corbett / ; Amy Corneli / ; Anna Dow / ; Ann Duerr / ; Henry Eliya / ; Sascha Ellington / ; Joseph Eron / ; Sherry Farr / ; Yvonne Owens Ferguson / ; Susan Fiscus / ; Valerie Flax / ; Ali Fokar / ; Shannon Galvin / ; Laura Guay / ; Chad Heilig / ; Irving Hoffman / ; Elizabeth Hooten / ; Mina Hosseinipour / ; Michael Hudgens / ; Stacy Hurst / ; Lisa Hyde / ; Denise Jamieson / ; George Joaki / ; David Jones / ; Elizabeth Jordan-Bell / ; Zebrone Kacheche / ; Esmie Kamanga / ; Gift Kamanga / ; Coxcilly Kampani / ; Portia Kamthunzi / ; Deborah Kamwendo / ; Cecilia Kanyama / ; Angela Kashuba / ; Damson Kathyola / ; Dumbani Kayira / ; Peter Kazembe / ; Caroline C King / ; Rodney Knight / ; Athena P Kourtis / ; Robert Krysiak / ; Jacob Kumwenda / ; Hana Lee / ; Edde Loeliger / ; Dustin Long / ; Misheck Luhanga / ; Victor Madhlopa / ; Maganizo Majawa / ; Alice Maida / ; Cheryl Marcus / ; Francis Martinson / ; Navdeep Thoofer / ; Chrissie Matiki / ; Douglas Mayers / ; Isabel Mayuni / ; Marita McDonough / ; Joyce Meme / ; Ceppie Merry / ; Khama Mita / ; Chimwemwe Mkomawanthu / ; Gertrude Mndala / ; Ibrahim Mndala / ; Agnes Moses / ; Albans Msika / ; Wezi Msungama / ; Beatrice Mtimuni / ; Jane Muita / ; Noel Mumba / ; Bonface Musis / ; Charles Mwansambo / ; Gerald Mwapasa / ; Jacqueline Nkhoma / ; Megan Parker / ; Richard Pendame / ; Ellen Piwoz / ; Byron Raines / ; Zane Ramdas / ; John Rublein / ; Mairin Ryan / ; Ian Sanne / ; Christopher Sellers / ; Diane Shugars / ; Dorothy Sichali / ; Wendy Snowden / ; Alice Soko / ; Allison Spensley / ; Jean-Marc Steens / ; Gerald Tegha / ; Martin Tembo / ; Roshan Thomas / ; Hsiao-Chuan Tien / ; Beth Tohill / ; Charles van der Horst / ; Esther Waalberg / ; Elizabeth Widen / ; Jeffrey Wiener / ; Cathy Wilfert / ; Patricia Wiyo / ; Innocent Zgambo / ; Chifundo Zimba /
Comments/Corrections
Comment In:
Lancet. 2012 Jun 30;379(9835):2405-7   [PMID:  22541419 ]

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