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

Author:

Krogstad Paul1,Samson Pearl2,Acosta Edward P3,Moye Jack4,Townley Ellen5,Bradford Sarah6,Brown Emily6,Denson Kayla7,Graham Bobbie7,Hovind Laura7,Sise Thucuma5,Teppler Hedy8,Mathiba Sisinyana Ruth9,Fairlie Lee10,Winckler Jana L11,Slade Gretchen12,Meyers Tammy13,

Affiliation:

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

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.

Funder

National Institute of Allergy and Infectious Diseases

Eunice Kennedy Shriver National Institute of Child Health and Human Development

National Institute of Mental Health

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,General Medicine,Pediatrics, Perinatology, and Child Health

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