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Safety, Tolerability, and Antiretroviral Activity of Raltegravir in HIV-1 Infected Russian Children and Adolescents - a 24 Week Study
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Reported by Jules Levin
IDSA Oct 8-12 Philadelphia, PA
H. Teppler1, A. Shuldyakov2, N. Gankina3, V. Kulagin4, F. Nagimova5, T. Shimonova6, D. Sonin7, V. Sotnikov8, N. Zakharova9, B. Homony1, D. Wang1, G. Moshkovich10
1Merck & Co., Inc., Whitehouse Station, NJ, USA; 2Regional Center for Prevention & Control of AIDS & Infectious Diseases, Saratov, Russia; 3Regional Center for Prevention & Control of AIDS & Infectious Diseases, Krasnoyarsk, Russia; 4Clinical Center for Prevention & Control of AIDS & Infectious Diseases, Krasnodar, Russia; 5Republican Center for Prevention & Control of AIDS & Infectious Diseases, Kazan, Russia; 6Infectious Clinical Hospital #2, Moscow, Russia; 7Regional Clinical Dermatovenerologic Dispensary, Ryazan, Russia; 8Regional Center for Prophylaxis & Control of AIDS & Infectious Diseases, Kaluga, Russia; 9Centre for Prophylaxis & Control of AIDS & Infectious Diseases, St. Petersburg, Russia; 10Regional Centre for Prevention & Control of AIDS & Infectious Diseases, Nizhniy Novgorod, Russia
FDA Approves Issentress (raltegravir): pediatric dosing recommendations and 2 chewable tablet formulations for pediatric dosing......
http://www.natap.org/2011/newsUpdates/122211_08.htm
(Issentress) Raltegravir for Pediatrics: Interim Results from IMPAACT P1066: Raltegravir (RAL) Oral Chewable Tablet (CT) Formulation in Children 2-5 Years - CROI 2011 Presentation & attached FDA Label containing pediatric safety, PK, dosing, efficacy......
http://www.natap.org/2012/HIV/010912_06.htm
CID/2014 - Pharmacokinetics, Safety, and 48-Week Efficacy of Oral Raltegravir in HIV-1-Infected Children Aged 2 Through 18 Years......
http://www.natap.org/2014/HIV/012214_02.htm
Safety and Efficacy of Raltegravir (RAL) in Pediatric HIV Infection. Preliminary Analysis From IMPAACT P1066.....http://www.natap.org/2009/CROI/croi_71.htm
A Pharmacokinetic Comparison of Adult and Pediatric Formulations of Raltegravir (RAL) in Healthy Adults.....http://www.natap.org/2010/CROI/croi_118.htm
Raltegravir Safe for Pregnant Women and Their Newborns in 31-Case Study.....http://www.natap.org/2013/ICAAC/ICAAC_62.htm......."We report three cases in which raltegravir was used late in pregnancy to rapidly reduce maternal HIV-1 viral load (Roche Taqman 2.0 assay), in women with multidrug resistant virus."
[PDF] Isentress (raltegravir) Prescribing Information - NATAP
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