Browsing by Author "Rosemary Gazu"

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    Pharmacokinetics and safety of maraviroc in neonates
    (2021-03-01) Julia C. Rosebush; Brookie M. Best; Ellen G. Chadwick; Kevin Butler; John Moye; Elizabeth Smith; Sarah Bradford; Christina A. Reding; Sisinyana R. Mathiba; Sherika Hanley; Mariam Aziz; James Homans; Edward P. Acosta; William Murtaugh; Manoli Vourvahis; Lynn McFadyen; Katy Hayward; Mark Mirochnick; Pearl Samson; Ntatule Hilda Ndiweni; Zaakirah Essack; Mandisa Nyati; Lorna Pillay; Rosemary Gazu; Natasha Pillay; Damien Sookoo; Kulkanya Chokephaibulkit; Supattra Rungmaitree; Keswadee Lapphra; Orasri Wittawatmongkol; Isaac Tsikhutsu; Edner Openda; Priscillah Bii; David Wekulo; Ellen Chadwick; Jessica D’Angelo; Margaret Ann Sanders; Alice Stek; Mikhaela Cielo; La Shonda Spencer; Yvonne Morales; Christiana Smith-Anderson; Kacey Navarro; Carrie Glenny; Elizabeth McFarland; R. N. Maureen McNichols; Julie Schmidt; Helen Cejtin; Ixchell Ortiz-Estes; Katherine Knapp; Nehali Patel; Patricia M. Flynn; Jill Utech; Kathleen George; Shane Reynolds; Terence Fenton; Michelle Hsu; Jamie Branco-Ricard; Victoria Wong; Barbara Heckman; Kyle Whitson; Shawn Ward; Navdeep K. Thoofer; Siriraj Hospital; FHI 360; ViiV Healthcare; Pfizer Limited, UK; Frontier Science & Technology Research Foundation, Inc.; Kenya Medical Research Institute; Harvard T.H. Chan School of Public Health; University of California, San Diego; University of Southern California; The University of Chicago; The University of Alabama at Birmingham; Children's Hospital Los Angeles; St. Jude Children's Research Hospital; Boston University; Rush University Medical Center; National Institute of Allergy and Infectious Diseases (NIAID); Ann & Robert H. Lurie Children's Hospital of Chicago; University of the Witwatersrand, Johannesburg; University of KwaZulu-Natal; National Institutes of Health (NIH); Rush University; IMPAACT Statistical and Data Analysis Center; IMPAACT Data Management Center; IMPAACT Laboratory Center; CAPRISA Umlazi Clinical Research Site; IMPAACT Operations Center; University of Colorado; Ann and Robert H. Lurie Children's Hospital of Chicago; Eunice Kennedy Shriver National Institute of Child Health and Human Development; Pfizer Global Research and Development
    Objective: The aim of this study was to evaluate safety and pharmacokinetics of maraviroc administered with standard antiretroviral prophylaxis to HIV-1 exposed infants and to determine the appropriate dose of maraviroc during the first 6 weeks of life. Design: A phase I, multicentre, open-label study enrolling two sequential cohorts. Methods: IMPAACT 2007 participants enrolled by day 3 of life and were stratified by exposure to maternal efavirenz. Cohort 1 participants received two single 8 mg/kg maraviroc doses 1 week apart with pharmacokinetic sampling after each dose. Cohort 2 participants received 8 mg/kg maraviroc twice daily through 6 weeks of life with pharmacokinetic sampling at weeks 1 and 4. Maraviroc exposure target was Cavg at least 75 ng/ml. Laboratory and clinical evaluations assessed safety. Results: Fifteen Cohort 1 and 32 Cohort 2 HIV-exposed neonates were enrolled (median gestational age 39 weeks, 51% male). All 13 evaluable Cohort 1 infants met the pharmacokinetic target. Median exposure for the 25 evaluable Cohort 2 infants met the pharmacokinetic target but variability was high, with 17–33% of infants below target at Weeks 1 and 4. Pharmacokinetic target achievement was similar between efavirenz exposure strata. No Grade 3þ toxicities, early study or treatment discontinuations due to maraviroc occurred. Conclusion: Median maraviroc exposure met the Cavg target in neonates receiving 8 mg/kg twice daily, although exposures were variable. Maternal efavirenz use did not impact maraviroc exposure and no discontinuations were due to maraviroc toxicity/ intolerance. No infants acquired HIV-1 infection during follow-up. Maraviroc 8 mg/kg twice daily appears well tolerated during the first 6 weeks of life.