title: 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.
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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: L A
authors.initials: LA
authors.lastname: Guay
authors.forename: P
authors.initials: P
authors.lastname: Musoke
authors.forename: T
authors.initials: T
authors.lastname: Fleming
authors.forename: D
authors.initials: D
authors.lastname: Bagenda
authors.forename: M
authors.initials: M
authors.lastname: Allen
authors.forename: C
authors.initials: C
authors.lastname: Nakabiito
authors.forename: J
authors.initials: J
authors.lastname: Sherman
authors.forename: P
authors.initials: P
authors.lastname: Bakaki
authors.forename: C
authors.initials: C
authors.lastname: Ducar
authors.forename: M
authors.initials: M
authors.lastname: Deseyve
authors.forename: L
authors.initials: L
authors.lastname: Emel
authors.forename: M
authors.initials: M
authors.lastname: Mirochnick
authors.forename: M G
authors.initials: MG
authors.lastname: Fowler
authors.forename: L
authors.initials: L
authors.lastname: Mofenson
authors.forename: P
authors.initials: P
authors.lastname: Miotti
authors.forename: K
authors.initials: K
authors.lastname: Dransfield
authors.forename: D
authors.initials: D
authors.lastname: Bray
authors.forename: F
authors.initials: F
authors.lastname: Mmiro
authors.forename: J B
authors.initials: JB
authors.lastname: Jackson
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission*; D015497:HIV-1; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D019829:Nevirapine / Q000008:administration & dosage / Q000627:therapeutic use*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000821:virology*; D014454:Uganda / Q000453:epidemiology; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D015215:Zidovudine; D019829:Nevirapine