Title |
Lopinavir/Ritonavir versus Lamivudine peri-exposure prophylaxis to prevent HIV-1 transmission by breastfeeding: the PROMISE-PEP trial Protocol ANRS 12174
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Published in |
BMC Infectious Diseases, October 2012
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DOI | 10.1186/1471-2334-12-246 |
Pubmed ID | |
Authors |
Nicolas Nagot, Chipepo Kankasa, Nicolas Meda, Justus Hofmeyr, Cheryl Nikodem, James K Tumwine, Charles Karamagi, Halvor Sommerfelt, Dorine Neveu, Thorkild Tylleskär, Philippe Van de Perre, for the PROMISE-PEP group |
Abstract |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Unknown | 3 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 3 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Switzerland | 1 | <1% |
Ethiopia | 1 | <1% |
Kenya | 1 | <1% |
Brazil | 1 | <1% |
United Kingdom | 1 | <1% |
Unknown | 193 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 42 | 21% |
Researcher | 35 | 18% |
Student > Ph. D. Student | 23 | 12% |
Other | 17 | 9% |
Student > Bachelor | 11 | 6% |
Other | 28 | 14% |
Unknown | 42 | 21% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 68 | 34% |
Nursing and Health Professions | 20 | 10% |
Social Sciences | 14 | 7% |
Agricultural and Biological Sciences | 8 | 4% |
Psychology | 7 | 4% |
Other | 35 | 18% |
Unknown | 46 | 23% |