Document Detail

Short postexposure prophylaxis in newborn babies to reduce mother-to-child transmission of HIV-1: NVAZ randomised clinical trial.
MedLine Citation:
PMID:  14568737     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: In sub-Saharan Africa, most women present late for delivery with unknown HIV status, which limits the use of intrapartum nevirapine to prevent mother-to-child transmission of HIV. We aimed to determine whether post-exposure prophylaxis of nevirapine plus zidovudine given to babies only reduced transmission of HIV more than did a regimen of nevirapine alone. METHODS: We randomly assigned 1119 babies of Malawian women with HIV-1 who presented late (ie, within 2 h of expected delivery) to either nevirapine alone or nevirapine and zidovudine. Both drugs were given immediately after birth: one dose of nevirapine (2 mg/kg weight) was given as a single dose; babies in the nevirapine plus zidovudine group also received zidovudine twice daily for 1 week (4 mg/kg weight). Infant HIV infection was determined at birth and at 6-8 weeks. Primary outcome was HIV infection in babies at 6-8 weeks in those not infected at birth. Analysis was by intention to treat. FINDINGS: The overall rate of mother-to-child transmission at 6-8 weeks was 15.3% in 484 babies who received nevirapine and zidovudine and 20.9% in 468 babies who received nevirapine only (p=0.03). At 6-8 weeks, in babies who were HIV negative at birth, 34 (7.7%) babies who had nevirapine and zidovudine and 51 (12.1%) who received nevirapine only were infected (p=0.03)-a protective efficacy of 36%. This finding remained after controlling for maternal viral load and other factors at baseline. Adverse events were mild and of similar frequency in the two groups. INTERPRETATION: Postexposure prophylaxis can offer protection against HIV infection to babies of women who missed opportunities to be counselled and tested before or during pregnancy. The nevirapine and zidovudine regimen is safe and easy to implement.
Taha E Taha; Newton I Kumwenda; Amanda Gibbons; Robin L Broadhead; Susan Fiscus; Valentino Lema; George Liomba; Chiwawa Nkhoma; Paolo G Miotti; Donald R Hoover
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Lancet     Volume:  362     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2003 Oct 
Date Detail:
Created Date:  2003-10-21     Completed Date:  2003-12-15     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1171-7     Citation Subset:  AIM; IM    
Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA.
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MeSH Terms
Anti-HIV Agents / therapeutic use
Follow-Up Studies
HIV Infections / prevention & control,  transmission*,  virology
HIV Seropositivity / diagnosis,  transmission,  virology
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Nevirapine / therapeutic use
Pregnancy Complications, Infectious / drug therapy*,  virology
Reverse Transcriptase Inhibitors / therapeutic use
Viral Load
Zidovudine / therapeutic use
Grant Support
Reg. No./Substance:
0/Anti-HIV Agents; 0/Reverse Transcriptase Inhibitors; 129618-40-2/Nevirapine; 30516-87-1/Zidovudine

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