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

Laura A. Guay, Philippa Musoke, Thomas Fleming, Danstan Bagenda, Melissa Allen, Clemensia Nakabiito, Joseph Sherman, Paul Bakaki, Constance Ducar, Martina Deseyve, Lynda Emel, Mark Mirochnick, Mary Glenn Fowler, Lynne Mofenson, Paolo Miotti, Kevin Dransfield, Dorothy Bray, Francis Mmiro, J. Brooks Jackson

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Abstract

Background. 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. Methods. 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. Findings. 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. Interpretation. 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.

Original languageEnglish (US)
Pages (from-to)795-802
Number of pages8
JournalLancet
Volume354
Issue number9181
DOIs
StatePublished - Sep 4 1999

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Nevirapine
Uganda
Zidovudine
HIV-1
Mothers
Parturition
Labor Onset
Breast Feeding
Pregnant Women
Kaplan-Meier Estimate
Clinical Protocols
Developed Countries
Developing Countries
HIV Infections
Acquired Immunodeficiency Syndrome
Clinical Trials
RNA

ASJC Scopus subject areas

  • Medicine(all)

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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. / Guay, Laura A.; Musoke, Philippa; Fleming, Thomas; Bagenda, Danstan; Allen, Melissa; Nakabiito, Clemensia; Sherman, Joseph; Bakaki, Paul; Ducar, Constance; Deseyve, Martina; Emel, Lynda; Mirochnick, Mark; Fowler, Mary Glenn; Mofenson, Lynne; Miotti, Paolo; Dransfield, Kevin; Bray, Dorothy; Mmiro, Francis; Jackson, J. Brooks.

In: Lancet, Vol. 354, No. 9181, 04.09.1999, p. 795-802.

Research output: Contribution to journalArticle

Guay, LA, Musoke, P, Fleming, T, Bagenda, D, Allen, M, Nakabiito, C, Sherman, J, Bakaki, P, Ducar, C, Deseyve, M, Emel, L, Mirochnick, M, Fowler, MG, Mofenson, L, Miotti, P, Dransfield, K, Bray, D, Mmiro, F & Jackson, JB 1999, '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', Lancet, vol. 354, no. 9181, pp. 795-802. https://doi.org/10.1016/S0140-6736(99)80008-7
Guay, Laura A. ; Musoke, Philippa ; Fleming, Thomas ; Bagenda, Danstan ; Allen, Melissa ; Nakabiito, Clemensia ; Sherman, Joseph ; Bakaki, Paul ; Ducar, Constance ; Deseyve, Martina ; Emel, Lynda ; Mirochnick, Mark ; Fowler, Mary Glenn ; Mofenson, Lynne ; Miotti, Paolo ; Dransfield, Kevin ; Bray, Dorothy ; Mmiro, Francis ; Jackson, J. Brooks. / 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. In: Lancet. 1999 ; Vol. 354, No. 9181. pp. 795-802.
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abstract = "Background. 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. Methods. 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. Findings. 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. Interpretation. 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.",
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T1 - Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda

T2 - HIVNET 012 randomised trial

AU - Guay, Laura A.

AU - Musoke, Philippa

AU - Fleming, Thomas

AU - Bagenda, Danstan

AU - Allen, Melissa

AU - Nakabiito, Clemensia

AU - Sherman, Joseph

AU - Bakaki, Paul

AU - Ducar, Constance

AU - Deseyve, Martina

AU - Emel, Lynda

AU - Mirochnick, Mark

AU - Fowler, Mary Glenn

AU - Mofenson, Lynne

AU - Miotti, Paolo

AU - Dransfield, Kevin

AU - Bray, Dorothy

AU - Mmiro, Francis

AU - Jackson, J. Brooks

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N2 - Background. 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. Methods. 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. Findings. 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. Interpretation. 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.

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