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Lopinavir/Ritonavir versus Lamivudine peri-exposure prophylaxis to prevent HIV-1 transmission by breastfeeding: the PROMISE-PEP trial Protocol ANRS 12174.
Nagot N., Kankasa C., Meda N., Hofmeyr J., Nikodem C., Tumwine J., Karamagi C., Sommerfelt H., Neveu D., Tylleskär T. et al
BMC Infectious Diseases 12, 1 (2012) 246 - http://www.hal.inserm.fr/inserm-00746898
Lopinavir/Ritonavir versus Lamivudine peri-exposure prophylaxis to prevent HIV-1 transmission by breastfeeding: the PROMISE-PEP trial Protocol ANRS 12174.
Nicolas Nagot () 1, 2, 3, Chipepo Kankasa4, Nicolas Meda5, Justus Hofmeyr6, Cheryl Nikodem6, James Tumwine7, Charles Karamagi7, 8, Halvor Sommerfelt8, 9, Dorine Neveu1, 3, Thorkild Tylleskär8, Philippe Van de Perre1, 2, 3, the PROMISE-PEP group Collaboration(s)
1 :  UM1 - Université Montpellier 1
Université Montpellier I – PRES Sud de France
5, boulevard Henri IV - CS 19044 - 34967 Montpellier cedex
2 :  Département de Bactériologie-Virologie et Département d'Information Médicale
CHRU Montpellier
3 :  Infection par le VIH et par agents à tropisme cutanéo-muqueux: de la pathogénèse à la prévention
INSERM : U1058
Hôpital Arnaud de Villeneuve 371 AV Doyen Gaston Giraud, Labo de bactériologie 34295 CEDEX 5 MONTPELLIER
4 :  Department of Paediatrics and Child Health
University of Zambia
School of Medicine, Lusaka
5 :  Centre of International Research for Health
University of Ouagadougou – Centre MURAZ, Bobo-Dioulasso
Faculty of Health Sciences
Burkina Faso
6 :  University of Western Cape
University of Western Cape
Cape Town
Afrique Du Sud
7 :  Department of Paediatrics and Child Health
School of Medicine Makerere University
College of Health Sciences, , Kampala
8 :  Centre for International Health
University of Bergen
Centre for International Health, University of Bergen, Bergen, Norway
9 :  Division of Infectious Disease Control
Norwegian Institute of Public Health
ABSTRACT: BACKGROUND: Postnatal transmission of HIV-1 through breast milk remains an unsolved challenge in many resource-poor settings where replacement feeding is not a safe alternative. WHO now recommends breastfeeding of infants born to HIV-infected mothers until 12 months of age, with either maternal highly active antiretroviral therapy (HAART) or peri-exposure prophylaxis (PEP) in infants using nevirapine. As PEP, lamivudine showed a similar efficacy and safety as nevirapine, but with an expected lower rate of resistant HIV strains emerging in infants who fail PEP, and lower restrictions for future HIV treatment. Lopinavir/ritonavir (LPV/r) is an attractive PEP candidate with presumably higher efficacy against HIV than nevirapine or lamivudine, and a higher genetic barrier to resistance selection. It showed an acceptable safety profile for the treatment of very young HIV-infected infants. The ANRS 12174 study aims to compare the risk of HIV-1 transmission during and safety of prolonged infant PEP with LPV/r (40/10 mg twice daily if 2-4 kg and 80/20 mg twice daily if >4 kg) versus Lamivudine (7,5 mg twice daily if 2-4 kg, 25 mg twice daily if 4-8 kg and 50 mg twice daily if >8 kg) from day 7 until one week after cessation of BF (maximum 50 weeks of prophylaxis) to prevent postnatal HIV-1 acquisition between 7 days and 50 weeks of age. METHODS: The ANRS 12174 study is a multinational, randomised controlled clinical trial conducted on 1,500 mother-infant pairs in Burkina Faso, South Africa, Uganda and Zambia. We will recommend exclusive breastfeeding (EBF) until 26th week of life and cessation of breastfeeding at a maximum of 49 weeks in both trial arms.HIV-uninfected infants at day 7 (± 2 days) born to HIV-1 infected mothers not eligible for HAART who choose to breastfeed their infants.The primary endpoint is the acquisition of HIV-1 (as assessed by HIV-1 DNA PCR) between day 7 and 50 weeks of age. Secondary endpoints are safety (including resistance, adverse events and growth) until 50 weeks and HIV-1-free survival until 50 weeks. DISCUSSION: This study will provide a new evidence-based intervention to support HIV-1-infected women not eligible for HAART to safely breastfeed their babies. TRIAL REGISTRATION NUMBER ( HTTP://WWW.CLINICALTRIALS.GOV): NCT00640263.
Sciences du Vivant/Médecine humaine et pathologie/Maladies infectieuses

Articles dans des revues avec comité de lecture
BMC Infectious Diseases (BMC Infect Dis)
Publisher BioMed Central
ISSN 1471-2334 

Sponsor: France National Agency for Research on AIDS & Hepatitis (ANRS) Other funding bodies: European Developing Countries Clinical Trials Partnership (EDCTP) and Research Council of Norway
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