Journal article
Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial
The Lancet (British edition), Vol.354(9181), pp.795-802
09/04/1999
DOI: 10.1016/S0140-6736(99)80008-7
PMID: 10485720
Abstract
The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis regimen for HIV-1-infected pregnant women and their babies has been associated with a significant decrease in vertical HIV-1 transmission in non-breastfeeding women in developed countries. We compared the safety and efficacy of short-course nevirapine or zidovudine during labour and the first week of life.
From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested babies for HIV-1 infection at birth, 6–8 weeks, and 14–16 weeks by HIV-1 RNA PCR. We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis.
Nearly all babies (98·8%) were breastfed, and 95·6% were still breastfeeding at age 14–16 weeks. The estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were: 10·4% and 8·2% at birth (p=0·354); 21·3% and 11·9% by age 6–8 weeks (p=0·0027); and 25·1% and 13·1% by age 14–16 weeks (p=0·0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 20–64) up to age 14–16 weeks. The two regimens were well tolerated and adverse events were similar in the two groups.
Nevirapine lowered the risk of HIV-1 transmission during the first 14–16 weeks of life by nearly 50% in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in less-developed countries.
Details
- Title: Subtitle
- Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial
- Creators
- Laura A Guay - Department of Pathology, Johns Hopkins University School of Medicine, Carnegie Building, Room 420, 600 North Wolfe Street, Baltimore, MD, USAPhilippa Musoke - Department of Paediatrics, Makerere University, Kampala, UgandaThomas Fleming - HIVNET Statistical Center, Fred Hutchinson Cancer Research Center, SeattleDanstan Bagenda - Department of Obstetrics and Gynaecology, Makerere University, KampalaMelissa Allen - Family Health International, Durham, NC, USAClemensia Nakabiito - Department of Obstetrics and Gynaecology, Makerere University, KampalaJoseph Sherman - Department of Pathology, Johns Hopkins University School of Medicine, Carnegie Building, Room 420, 600 North Wolfe Street, Baltimore, MD, USAPaul Bakaki - Department of Biostatistics, University of Washington, Seattle, WA, USAConstance Ducar - Department of Pathology, Johns Hopkins University School of Medicine, Carnegie Building, Room 420, 600 North Wolfe Street, Baltimore, MD, USAMartina Deseyve - HIVNET Statistical Center, Fred Hutchinson Cancer Research Center, SeattleLynda Emel - HIVNET Statistical Center, Fred Hutchinson Cancer Research Center, SeattleMark Mirochnick - Department of Pediatrics, Boston University, Boston, MA, USAMary Glenn Fowler - Division of AIDS, NIAID/NIH, Bethesda, MD, USALynne Mofenson - Pediatric, Adolescent, and Maternal AIDS Branch, NICHD/NIH, BethesdaPaolo Miotti - Division of AIDS, NIAID/NIH, Bethesda, MD, USAKevin Dransfield - Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USADorothy Bray - Glaxo-Wellcome, London, UKFrancis Mmiro - Department of Obstetrics and Gynaecology, Makerere University, KampalaJ Brooks Jackson - Department of Pathology, Johns Hopkins University School of Medicine, Carnegie Building, Room 420, 600 North Wolfe Street, Baltimore, MD, USA
- Resource Type
- Journal article
- Publication Details
- The Lancet (British edition), Vol.354(9181), pp.795-802
- Publisher
- Elsevier Ltd
- DOI
- 10.1016/S0140-6736(99)80008-7
- PMID
- 10485720
- ISSN
- 0140-6736
- eISSN
- 1474-547X
- Language
- English
- Date published
- 09/04/1999
- Academic Unit
- Pathology; VPMA - Administration
- Record Identifier
- 9984047778402771
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