Pharmacokinetics and Safety of a Raltegravir-Containing Regimen in Children Aged 4 Weeks to 2 Years Living With Human Immunodeficiency Virus and Receiving Rifampin for Tuberculosis

Paul Krogstad; Pearl Samson; Edward P Acosta; Jack Moye; Ellen Townley; Sarah Bradford; Emily Brown; Kayla Denson; Bobbie Graham; Laura Hovind; Thucuma Sise; Hedy Teppler; Sisinyana Ruth Mathiba; Lee Fairlie; Jana L Winckler; Gretchen Slade; Tammy Meyers; International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1101 Team

doi:10.1093/jpids/piaa039

Pharmacokinetics and Safety of a Raltegravir-Containing Regimen in Children Aged 4 Weeks to 2 Years Living With Human Immunodeficiency Virus and Receiving Rifampin for Tuberculosis

J Pediatric Infect Dis Soc. 2021 Mar 26;10(2):201-204. doi: 10.1093/jpids/piaa039.

Authors

Paul Krogstad¹, Pearl Samson², Edward P Acosta³, Jack Moye⁴, Ellen Townley⁵, Sarah Bradford⁶, Emily Brown⁶, Kayla Denson⁷, Bobbie Graham⁷, Laura Hovind⁷, Thucuma Sise⁵, Hedy Teppler⁸, Sisinyana Ruth Mathiba⁹, Lee Fairlie¹⁰, Jana L Winckler¹¹, Gretchen Slade¹², Tammy Meyers¹³; International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1101 Team

Affiliations

¹ Departments of Pediatrics and Molecular and Medical Pharmacology, David Geffen School of Medicine at Los Angeles, Los Angeles, California, USA.
² Statistical and Data Management Center, Frontier Science Foundation/Harvard T.H. Chan School of Public Health Boston, Massachusetts, USA.
³ Department of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
⁴ Maternal and Pediatric Infectious Disease Branch, Division of Extramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA.
⁵ Columbus Technologies and Services, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
⁶ FHI360, Durham, North Carolina, USA.
⁷ Frontier Science Foundation, Inc, Amherst, New York, USA.
⁸ Global Clinical Development - Infectious Diseases, Merck & Co, Inc, Kenilworth, New Jersey, USA.
⁹ Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
¹⁰ Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
¹¹ Desmond Tutu TB Centre, Department of Paediatrics, Stellenbosch University, Cape Town South Africa.
¹² Department of Paediatrics and Child Health, Family Clinical Research Unit, Stellenbosch University, Cape Town, South Africa.
¹³ Department of Paediatrics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Abstract

Pharmacological interactions limit treatment options for children living with human immunodeficiency virus (HIV) and tuberculosis (TB). We found that 12 mg/kg twice daily raltegravir chewable tablets (administered after crushing) safely achieved pharmacokinetic targets in children living with HIV aged 4 weeks to <2 years receiving concurrent rifampin to treat TB.

Clinical trials registration: NCT01751568.

Keywords: antiretroviral therapy; drug interactions; pediatrics; rifampin; tuberculosis.

© The Author(s) 2020. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Publication types

Clinical Trial

MeSH terms

Anti-HIV Agents* / therapeutic use
Child
HIV
HIV Infections* / drug therapy
Humans
Raltegravir Potassium / adverse effects
Rifampin / adverse effects
Tuberculosis* / complications
Tuberculosis* / drug therapy

Pharmacokinetics and Safety of a Raltegravir-Containing Regimen in Children Aged 4 Weeks to 2 Years Living With Human Immunodeficiency Virus and Receiving Rifampin for Tuberculosis

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