PMID: identifiant
de la référence Pubmed : |
 |
 (23039034)  |
|
| titre : |
|
Lopinavir/Ritonavir versus Lamivudine peri-exposure prophylaxis to prevent HIV-1 transmission by breastfeeding: the PROMISE-PEP trial Protocol ANRS 12174. |
|
| auteur(s) : |
|
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) |
|
| laboratoire : |
|
|
|
| résumé : |
|
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. |
|
| domaine : |
|
Sciences du Vivant/Médecine humaine et pathologie/Maladies infectieuses
|
|
langue du texte
intégral : |
|
Anglais |
|
| ISSN : |
|
1471-2334 |
|
|
| type de publication : |
|
Articles dans des revues avec comité de lecture |
|
| DOI : |
|
10.1186/1471-2334-12-246 |
|
| journal : |
|
| BMC Infectious Diseases (BMC Infect Dis) |
| Publisher |
BioMed Central |
| ISSN |
1471-2334 |
|
|
| Audience : |
|
internationale |
|
| date de publication : |
|
2012 |
|
date de publication
électronique : |
|
06/10/2012 |
|
| volume : |
|
12 |
|
| numéro : |
|
1 |
|
| page, identifiant, ... : |
|
246 |
|
|
| contrat, financement : |
|
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 |
|
