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Pharmacokinetics and safety of maraviroc in neonates.
Rosebush, Julia C; Best, Brookie M; Chadwick, Ellen G; Butler, Kevin; Moye, John; Smith, Elizabeth; Bradford, Sarah; Reding, Christina A; Mathiba, Sisinyana R; Hanley, Sherika; Aziz, Mariam; Homans, James; Acosta, Edward P; Murtaugh, William; Vourvahis, Manoli; Mcfadyen, Lynn; Hayward, Katy; Mirochnick, Mark; Samson, Pearl.
Afiliación
  • Rosebush JC; University of Chicago, Chicago, Illinois.
  • Best BM; University of California San Diego, La Jolla, California.
  • Chadwick EG; Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.
  • Butler K; Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
  • Moye J; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda.
  • Smith E; Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, Maryland.
  • Bradford S; FHI 360, Durham, North Carolina.
  • Reding CA; Frontier Science & Technology Research Foundation, Inc., Amherst, New York, USA.
  • Mathiba SR; Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg.
  • Hanley S; Centre for the AIDS Programme in South Africa, University of KwaZulu-Natal, Durban, South Africa.
  • Aziz M; Rush University Medical Center, Chicago, Illinois.
  • Homans J; University of Southern California, Los Angeles, California.
  • Acosta EP; Deparment of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, Alabama.
  • Murtaugh W; IMPAACT Laboratory Center, Children's Hospital of Los Angeles, Los Angeles, California.
  • Vourvahis M; Clinical Pharmacology, Pfizer Global Research and Development, New York, New York, USA.
  • Mcfadyen L; Pharmacometrics, Pfizer Global Research and Development, Sandwich, UK.
  • Hayward K; ViiV HealthCare, Research Triangle Park, North Carolina.
  • Mirochnick M; Boston University, Boston, Massachusetts, USA.
  • Samson P; Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
AIDS ; 35(3): 419-427, 2021 03 01.
Article en En | MEDLINE | ID: mdl-33252481
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 3+ 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones por VIH / VIH-1 Tipo de estudio: Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male / Newborn Idioma: En Revista: AIDS Asunto de la revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones por VIH / VIH-1 Tipo de estudio: Etiology_studies / Incidence_studies / Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male / Newborn Idioma: En Revista: AIDS Asunto de la revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido