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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy of short-course AZT plus 3TC to reduce nevirapine resistance in the prevention of mother-to-child HIV transmission: A randomized clinical trial
PLoS Medicine, Volume 6, No. 10, Article e1000172, Year 2009
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Description
Background: Single-dose nevirapine (sdNVP) - which prevents mother-to-child transmission of HIV - selects non-nucleoside reverse-transcriptase inhibitor (NNRTI) resistance mutations in the majority of women and HIV-infected infants receiving it. This open-label, randomised trial examined the efficacy of short-course zidovudine (AZT) and lamivudine (3TC) with sdNVP in reducing NNRTI resistance in mothers, and as a secondary objective, in infants, in a setting where sdNVP was standard-ofcare. Methods and Findings:sdNVP alone, administered at the onset of labour and to the infant, was compared to sdNVP with AZT plus 3TC, given as combivir (CBV) for 4 (NVP/CBV4) or 7 (NVP/CBV7) days, initiated simultaneously with sdNVP in labour; their newborns received the same regimens. Women were randomised 1:1:1. HIV-1 resistance was assessed by population sequencing at: baseline, 2, and 6 wk after birth. An unplanned interim analysis resulted in early stopping of the sdNVP arm. 406 pregnant women were randomised and took study medication (sdNVP 74, NVP/CBV4 164, and NVP/CBV7 168). HIV-1 resistance mutations emerged in 59.2%, 11.7%, and 7.3% of women in the sdNVP, NVP/CBV4, and NVP/CBV7 arms by 6 wk postpartum; differences between NVP-only and both NVP/CBV arms were significant (p<0.0001), but the difference between NVP/CBV4 and NVP/CBV7 was not (p = 0.27). Estimated efficacy comparing combined CBV arms with sdNVP was 85.6%. Similar resistance reductions were seen in infants who were HIV-infected by their 6-wk visit. Conclusions: A short course of AZT plus 3TC, supplementing maternal and infant sdNVP, reduces emergent NNRTI resistance mutations in both mothers and their infants. However, this trial was not powered to detect small differences between the CBV arms. Trial registration: http://www.ClinicalTrials.gov NCT 00144183. © 2009 McIntyre et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s002.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s003.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s004.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s005.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s006.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s007.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s008.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2760761/bin/pmed.1000172.s009.doc
Authors & Co-Authors
McIntyre, James Alasdair
South Africa, Johannesburg
University of the Witwatersrand
Hopley, Mark J.
South Africa, Johannesburg
Boehringer Ingelheim Pty Ltd
Moodley, Dhayendre
South Africa, Durban
The Nelson R. Mandela Medical School
Eklund, Marie
South Africa, Johannesburg
Boehringer Ingelheim Pty Ltd
Gray, Glenda E.
South Africa, Johannesburg
University of the Witwatersrand
Hall, David B.
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Robinson, Patrick
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Mayers, Douglas L.
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
United States, Cambridge
Idenix Pharmaceuticals, Inc.
Martinson, Neil Alexander
South Africa, Johannesburg
University of the Witwatersrand
United States, Baltimore
Johns Hopkins School of Medicine
Statistics
Citations: 95
Authors: 9
Affiliations: 6
Identifiers
Doi:
10.1371/journal.pmed.1000172
ISSN:
15491277
e-ISSN:
15491676
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Cross Sectional Study
Participants Gender
Female