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Raltegravir Pharmacokinetics and Safety in Adolescents:
Preliminary Results from IMPAACT P1066
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Reported by Jules Levin
ICAAC/IDSA Oct 2008, Wash DC
Sharon Nachman1, Edward Acosta2, Andrew Wiznia3, Hedy Teppler4, Mary Long2, Brenda Homany4, Bobbie Graham5, Carol Worrell6, Pearl Samson7, Edward Handelsman8, and the P1066 Protocol Team
1SUNY at Stony Brook, 2U of Ala Birm, 3Jacobi Med Ctr, Bronx, NY, 4Merck Research Labs, North Wales PA, 5Frontier Science Technology Research Foundation, Buffalo, NY, 6NICHD, Rockville, MD, 7Harvard School of Public Health, 8NIAID Rockville MD
AUTHOR CONCLUSIONS
Raltegravir was generally well tolerated.
HIV+ adolescents ages 12-18 receiving 8 mg/kg (mean dose 390 mg) bid achieved exposures similar to adults receiving 400 mg bid.
Stage II will assess safety and efficacy using a RAL 400 mf bid regimen in this age group, regardless of weight and without regard to food.
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