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
Department of Pediatrics
Adult; Anti-HIV Agents; Delivery, Obstetric; Drug Therapy, Combination; Female; HIV Infections; *HIV-1; Humans; Infant; Infant, Newborn; Infectious Disease Transmission, Vertical; Labor, Obstetric; Lamivudine; Nevirapine; Pregnancy; Pregnancy Complications, Infectious; Reverse Transcriptase Inhibitors; Treatment Outcome; Zidovudine
Immunology and Infectious Disease | Pediatrics
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.
DOI of Published Version
J Infect Dis. 2003 Mar 1;187(5):725-35. Epub 2003 Feb 24. Link to article on publisher's site
The Journal of infectious diseases
Moodley, Dhayendre; Moodley, Jagidesa; Coovadia, Hoosen; Gray, Glenda; McIntyre, James; Hofmyer, Justus; Nikodem, Cheryl; Hall, David; Gigliotti, Maria; Robinson, Patrick; Boshoff, Lynette; and Sullivan, John L., "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" (2003). Immunology/Infectious Disease. 28.