TY - JOUR
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
N1 - Funding Information:
This trial was sponsored by the HIV Network for Prevention Trials, Division of AIDS, NIAID/National Institutes of Health contract no N01-AI-35173. We thank Estelle Piwowar-Manning, Gad Bihabwa, Simon Rugera, John Abima, Mugabe Ukumutima, and Bosco Kafufu for laboratory technical support; Deborah Donnell for statistical-analysis support; Scott Horton for randomisation and drug packaging design; Darryl Pahl and Mary Ann Klotz for DATAFAX support; Nuala McGrath, Vidya Gopal, and Maria Musisi for on-site data-management support; Sharla Estep for support with pharmaceutical regulations and packaging; Amal Murarka, Margaret Achom-Okwero, Henry Tumwijukye, Florence Kikonyogo, and all the staff of the MU-JHU Research Collaboration; Andrea Ruff for consultation; Rod Hoff of the Division of AIDS/NIAID/NIH, for his support of the HIVNET perinatal agenda and this trial in particular; Art Ammann and Cathy Wilfert for their input in the design and review of the protocol; Maureen Myers of Boehringer Ingelheim Pharmaceuticals Inc for her support and provision of nevirapine; John Sullivan, protocol chairperson of the Pediatric AIDS Clinical Trials ACTG 250 protocol team, who proposed the concept of nevirapine use for prevention of mother-to-child HIV-1 transmission; and the Ugandan mothers and babies who participated.
PY - 1999/9/4
Y1 - 1999/9/4
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.
AB - 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.
UR - https://www.scopus.com/pages/publications/0033523454
UR - https://www.scopus.com/pages/publications/0033523454#tab=citedBy
U2 - 10.1016/S0140-6736(99)80008-7
DO - 10.1016/S0140-6736(99)80008-7
M3 - Article
C2 - 10485720
AN - SCOPUS:0033523454
SN - 0140-6736
VL - 354
SP - 795
EP - 802
JO - Lancet
JF - Lancet
IS - 9181
ER -