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.

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.

[1]  M. Fowler,et al.  Prevention of mother-to-child HIV transmission in resource-poor countries: translating research into policy and practice. , 2000, JAMA.

[2]  J. Albert,et al.  Evaluation of a prototype Amplicor PCR assay for detection of human immunodeficiency virus type 1 DNA in blood samples from Tanzanian adults infected with HIV-1 subtypes A, C and D. , 2000, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[3]  N. Shaffer,et al.  Early diagnosis of HIV-1-infected infants in Thailand using RNA and DNA PCR assays sensitive to non-B subtypes. , 2000 .

[4]  Petra Study Team,et al.  Efficacy of three short-course regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (Petra study): a randomised, double-blind, placebo-controlled trial , 2002, The Lancet.

[5]  N. Shaffer,et al.  Early Diagnosis of HIV‐1‐Infected Infants in Thailand Using RNA and DNA PCR Assays Sensitive to Non‐B Subtypes , 2000, Journal of acquired immune deficiency syndromes.

[6]  W. Heneine,et al.  Early Detection of Reverse Transcriptase Activity in Plasma of Neonates Infected With HIV‐1: A Comparative Analysis With RNA‐Based and DNA‐Based Testing Using Polymerase Chain Reaction , 2001, Journal of acquired immune deficiency syndromes.

[7]  J. Karon,et al.  Short-course oral zidovudine for prevention of mother-to-child transmission of HIV-1 in Abidjan, Côte d'Ivoire: a randomised trial , 1999, The Lancet.

[8]  D. Katzenstein,et al.  Serum level of maternal human immunodeficiency virus (HIV) RNA, infant mortality, and vertical transmission of HIV in Zimbabwe. , 1999, The Journal of infectious diseases.

[9]  J. Karon,et al.  Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial , 1999, The Lancet.

[10]  Dorothy Bray,et al.  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 , 1999, The Lancet.

[11]  T. Quinn,et al.  Estimating the timing of mother-to-child transmission of human immunodeficiency virus in a breast-feeding population in Kinshasa, Zaire. , 1996, The Journal of infectious diseases.

[12]  K. Mcintosh,et al.  A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators. , 2000, The New England journal of medicine.

[13]  A. Kourtis,et al.  Understanding the timing of HIV transmission from mother to infant. , 2001, JAMA.

[14]  L. Mofenson,et al.  Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012) , 2001, AIDS.

[15]  N. Pedersen,et al.  Early Short-Term 9-[2-(R)-(Phosphonomethoxy)Propyl]Adenine Treatment Favorably Alters the Subsequent Disease Course in Simian Immunodeficiency Virus-Infected Newborn Rhesus Macaques , 1999, Journal of Virology.

[16]  F. Onyango,et al.  Effect of breastfeeding and formula feeding on transmission of HIV-1: a randomized clinical trial. , 2000, JAMA.

[17]  R. Gelber,et al.  "Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type I with Zidovudine Treatment." , 1994 .

[18]  L. Kuhn,et al.  Influence of infant-feeding patterns on early mother-to-child transmission of HIV-1 in Durban, South Africa: a prospective cohort study. South African Vitamin A Study Group. , 1999, Lancet.

[19]  R. Salamon,et al.  6-month efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Côte d'Ivoire and Burkina Faso: a double-blind placebo-controlled multicentre trial , 1999, The Lancet.

[20]  D. Wara,et al.  Proposed definitions for in utero versus intrapartum transmission of HIV-1. , 1992, The New England journal of medicine.

[21]  L. Mofenson.  Mother-child HIV-1 transmission: Timing and determinants. , 1997, Obstetrics and gynecology clinics of North America.

[22]  R. Gelber,et al.  Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. , 1994, The New England journal of medicine.

[23]  H. Coovadia,et al.  Influence of infant-feeding patterns on early mother-to-child transmission of HIV-1 in Durban, South Africa: a prospective cohort study , 1999, The Lancet.

[24]  M. Hudgens,et al.  Twenty-four month efficacy of a maternal short-course zidovudine regimen to prevent mother-to-child transmission of HIV-1 in West Africa , 2002, AIDS.

[25]  M. Kalish,et al.  Maternal viral load and timing of mother-to-child HIV transmission, Bangkok, Thailand. Bangkok Collaborative Perinatal HIV Transmission Study Group. , 1999, AIDS.