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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.
J Infect Dis 2003; 187(5):725-35JI

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+Show Affiliations

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.zaNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12599045

Citation

Moodley, Dhayendre, et al. "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." The Journal of Infectious Diseases, vol. 187, no. 5, 2003, pp. 725-35.
Moodley D, Moodley J, Coovadia H, et al. 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. J Infect Dis. 2003;187(5):725-35.
Moodley, D., Moodley, J., Coovadia, H., Gray, G., McIntyre, J., Hofmyer, J., ... Sullivan, J. L. (2003). 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. The Journal of Infectious Diseases, 187(5), pp. 725-35.
Moodley D, et al. 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. J Infect Dis. 2003 Mar 1;187(5):725-35. PubMed PMID: 12599045.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Moodley,Dhayendre, AU - Moodley,Jagidesa, AU - Coovadia,Hoosen, AU - Gray,Glenda, AU - McIntyre,James, AU - Hofmyer,Justus, AU - Nikodem,Cheryl, AU - Hall,David, AU - Gigliotti,Maria, AU - Robinson,Patrick, AU - Boshoff,Lynette, AU - Sullivan,John L, AU - ,, Y1 - 2003/02/24/ PY - 2002/09/20/received PY - 2002/10/07/revised PY - 2003/2/25/pubmed PY - 2003/4/4/medline PY - 2003/2/25/entrez SP - 725 EP - 35 JF - The Journal of infectious diseases JO - J. Infect. Dis. VL - 187 IS - 5 N2 - 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. SN - 0022-1899 UR - https://www.unboundmedicine.com/medline/citation/12599045/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_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1086/367898 DB - PRIME DP - Unbound Medicine ER -