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Clinical Trial
. 1999 Sep 4;354(9181):795-802.
doi: 10.1016/S0140-6736(99)80008-7.

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

L A Guay  1 , P Musoke, T Fleming, D Bagenda, M Allen, C Nakabiito, J Sherman, P Bakaki, C Ducar, M Deseyve, L Emel, M Mirochnick, M G Fowler, L Mofenson, P Miotti, K Dransfield, D Bray, F Mmiro, J B Jackson
Affiliations
Free article
Clinical Trial

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

L A Guay et al. Lancet. .
Free article

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.

PIP: A study was conducted to assess the safety and efficacy of short-course nevirapine compared with zidovudine given to women during labor and to neonates during the first week of life. 626 HIV-1 infected pregnant women attending the antenatal clinic from November 1997 to April 1999 at Mulago Hospital in Kampala, Uganda, were randomly given nevirapine or zidovudine. Infants were tested for HIV-1 infection at birth, at 6-8 weeks, and at 14-16 weeks. Findings revealed that the estimated risk of HIV-1 transmission in the zidovudine and nevirapine groups was 10.4% and 8.2%, respectively, at birth; 21.3% and 11.9%, by 6-8 weeks; and 25.1% and 13.1%, by 14-16 weeks. There was a 47% relative efficacy rate of the nevirapine regimen at 14-16 weeks compared to zidovudine. Based on the findings, nevirapine lowers the risk of HIV-1 transmission by nearly 50% during the first 14-16 weeks of life in breast-fed infants.

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Comment in

  • HIVNET nevirapine trials.
    Lurie P, Wolfe SM. Lurie P, et al. Lancet. 1999 Nov 20;354(9192):1816-7. doi: 10.1016/S0140-6736(99)99203-6. Lancet. 1999. PMID: 10577660 No abstract available.
  • HIVNET nevirapine trials.
    Campa AM, Shor-Posner G, Baum MK. Campa AM, et al. Lancet. 1999 Nov 20;354(9192):1817; author reply 1818. doi: 10.1016/S0140-6736(05)70582-1. Lancet. 1999. PMID: 10577661 No abstract available.
  • HIVNET nevirapine trials.
    Hudson CP, Moodley J. Hudson CP, et al. Lancet. 1999 Nov 20;354(9192):1817-8. doi: 10.1016/s0140-6736(05)70583-3. Lancet. 1999. PMID: 10577662 No abstract available.

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