title: A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early postpartum mother-to-child transmission of human immunodeficiency virus type 1.
abstract: To determine the efficacy and safety of 2 inexpensive and easily deliverable antiretroviral (ARV) regimens for the prevention of mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) type 1 during labor and delivery, HIV-infected pregnant women were screened at 11 maternity health institutions in South Africa and were enrolled in an open-label short course ARV regimen of either nevirapine (Nvp) or multiple-dose zidovudine and lamivudine (Zdv/3TC). The overall estimated HIV-1 infection rates in 1307 infants by 8 weeks were 12.3% (95% confidence interval [CI], 9.7-15.0) for Nvp and 9.3% (95% CI, 7.0-11.6) for Zdv/3TC (P=.11). Excluding infections detected within 72 h (intrauterine), new HIV-1 infections were detected in 5.7% (95% CI, 3.7-7.8) and 3.6% (95% CI, 2.0-5.3) of infants in the Nvp and Zdv/3TC groups, respectively, in the 8 weeks after birth. There were no drug-related maternal or pediatric serious adverse events. Common complications were obstetrical for mothers (Nvp group, 24.3%; Zdv/3TC group, 26.3%) and respiratory for infants (Nvp group, 16.1%; Zdv/3TC group, 17.0%). This study further confirms the efficacy and safety of short-course ARV regimens in reducing MTCT rates in developing countries.
authors.affiliation: Department of Obstetrics and Gynaecology, Paediatrics and Child Health, Nelson R. Mandela School of Medicine, University of Natal, KwaZulu Natal, Congella 4013, South Africa. moodleyj@nu.ac.za
authors.forename: Dhayendre
authors.initials: D
authors.lastname: Moodley
authors.forename: Jagidesa
authors.initials: J
authors.lastname: Moodley
authors.forename: Hoosen
authors.initials: H
authors.lastname: Coovadia
authors.forename: Glenda
authors.initials: G
authors.lastname: Gray
authors.forename: James
authors.initials: J
authors.lastname: McIntyre
authors.forename: Justus
authors.initials: J
authors.lastname: Hofmyer
authors.forename: Cheryl
authors.initials: C
authors.lastname: Nikodem
authors.forename: David
authors.initials: D
authors.lastname: Hall
authors.forename: Maria
authors.initials: M
authors.lastname: Gigliotti
authors.forename: Patrick
authors.initials: P
authors.lastname: Robinson
authors.forename: Lynette
authors.initials: L
authors.lastname: Boshoff
authors.forename: John L
authors.initials: JL
authors.lastname: Sullivan
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D036861:Delivery, Obstetric; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control / Q000635:transmission*; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007743:Labor, Obstetric; D019259:Lamivudine / Q000008:administration & dosage / Q000627:therapeutic use; D019829:Nevirapine / Q000008:administration & dosage / Q000627:therapeutic use; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000821:virology; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine