Document Detail

Nevirapine and zidovudine at birth to reduce perinatal transmission of HIV in an African setting: a randomized controlled trial.
MedLine Citation:
PMID:  15249569     Owner:  NLM     Status:  MEDLINE    
CONTEXT: Antenatal counseling and human immunodeficiency virus (HIV) testing are not universal in Africa; thus, women often present in labor with unknown HIV status without receiving the HIVNET 012 nevirapine (NVP) regimen (a single oral dose of NVP to the mother at the start of labor and to the infant within 72 hours of birth).
OBJECTIVE: To determine risk of mother-to-child transmission of HIV when either standard use of NVP alone or in combination with zidovudine (ZDV) was administered to infants of women tested at delivery.
DESIGN, SETTING, AND PARTICIPANTS: A randomized, open-label, phase 3 trial conducted between April 1, 2000, and March 15, 2003, at 6 clinics in Blantyre, Malawi, Africa. The trial included all infants born to 894 women who were HIV positive, received NVP intrapartum, and were previously antiretroviral treatment-naive. Infants were randomly assigned to NVP (n = 448) and NVP plus ZDV (n = 446). Infants were enrolled at birth, observed at 6 to 8 weeks, and followed up through 3 to 18 months. The HIV status of 90% of all infants was established at 6 to 8 weeks.
INTERVENTION: Mothers received a 200-mg single oral dose of NVP intrapartum and infants received either 2-mg/kg oral dose of NVP or NVP (same dose) plus 4 mg/kg of ZDV twice per day for a week.
MAIN OUTCOME MEASURES: HIV infection of infant at birth and 6 to 8 weeks, and adverse events.
RESULTS: The mother-to-child transmission of HIV at birth was 8.1% (36/445) in infants administered NVP only and 10.1% (45/444) in those administered NVP plus ZDV (P =.30). A life table estimate of transmission at 6 to 8 weeks was 14.1% (95% confidence interval [CI], 10.7%-17.4%) in infants who received NVP and 16.3% (95% CI, 12.7%-19.8%) in those who received NVP plus ZDV (P =.36). For infants not infected at birth and retested at 6 to 8 weeks, transmission was 6.5% (23/353) in those who received NVP only and 6.9% (25/363) in those who received NVP plus ZDV (P =.88). Almost all infants (99%-100%) were breastfed at 1 week and 6 to 8 weeks. Grades 3 and 4 adverse events were comparable; 4.9% (22/448) and 5.4% (24/446) in infants receiving NVP only and NVP plus ZDV, respectively (P =.76).
CONCLUSIONS: The frequency of mother-to-child HIV transmission at 6 to 8 weeks in our 2 study groups was comparable with that observed for other perinatal HIV intervention studies among breastfeeding women in Africa. The safety of the regimen containing neonatal ZDV was similar to that of a standard NVP regimen.
Taha E Taha; Newton I Kumwenda; Donald R Hoover; Susan A Fiscus; George Kafulafula; Chiwawa Nkhoma; Samah Nour; Shu Chen; George Liomba; Paolo G Miotti; Robin L Broadhead
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  JAMA     Volume:  292     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2004 Jul 
Date Detail:
Created Date:  2004-07-13     Completed Date:  2004-07-16     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  202-9     Citation Subset:  AIM; IM    
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MeSH Terms
AIDS Serodiagnosis
Anti-HIV Agents / therapeutic use*
Delivery, Obstetric
Drug Therapy, Combination
HIV Infections / congenital*,  drug therapy*,  prevention & control,  transmission
HIV-1 / genetics
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control
Nevirapine / therapeutic use*
Pregnancy Complications, Infectious / prevention & control
Survival Analysis
Viral Load
Zidovudine / therapeutic use*
Grant Support
Reg. No./Substance:
0/Anti-HIV Agents; 4B9XT59T7S/Zidovudine; 99DK7FVK1H/Nevirapine

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