Twice-Daily Dosing of Dolutegravir in Infants on
Rifampicin Treatment: A Pharmacokinetic Substudy
of the EMPIRICAL Trial
Tom G. Jacobs,1,a, Vivian Mumbiro,2,a Uneisse Cassia,3 Kevin Zimba,4 Damalie Nalwanga,5 Alvaro Ballesteros,6 Sara Domínguez-Rodríguez,6,
Alfredo Tagarro,6,7,8, Lola Madrid,6,9 Constantine Mutata,2 Moses Chitsamatanga,2 Mutsa Bwakura-Dangarembizi,2 Alfeu Passanduca,3 W. Chris Buck,3,10
Bwendo Nduna,11 Chishala Chabala,4,12,13 Elizabeth Najjingo,14 Victor Musiime,5,15 Cinta Moraleda,6,16 Angela Colbers,1, Hilda A. Mujuru,2,b
Pablo Rojo,6,16,17,b and David M. Burger1,b
; on Behalf of the EMPIRICAL Clinical Trial Group
1
Department of Pharmacy, Radboudumc Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands; 2
University of Zimbabwe Clinical Research Centre, Harare,
Zimbabwe; 3
Universidade Eduardo Mondlane Faculdade de Medicina, Maputo, Mozambique; 4
University Teaching Hospitals-Children’s Hospital, Lusaka, Zambia; 5
Department of Paediatrics and
Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda; 6
Pediatric Unit for Research and Clinical Trials, Hospital 12 de Octubre Health Research
Institute, Biomedical Foundation of Hospital Universitario 12 de Octubre, Madrid, Spain; 7
Pediatric Service, Infanta Sofia University Hospital, Servicio Madrileño de Salud, Madrid, Spain; 8
Universidad
Europea de Madrid, Madrid, Spain; 9
London School of Hygiene and Tropical Medicine, London, United Kingdom; 10David Geffen School of Medicine, University of California–Los Angeles, Los Angeles,
California, USA; 11Arthur Davidson Children’s Hospital, Ndola, Zambia; 12School of Medicine, University of Zambia, Lusaka, Zambia; 13HerpeZ, Lusaka, Zambia; 14Mbarara Regional Referral Hospital,
Mbarara, Uganda; 15Joint Clinical Research Centre, Kampala, Uganda; 16Pediatric Service, Hospital Universitario 12 de Octubre, Servicio Madrileño de Salud, Madrid, Spain; and 17Complutense
University of Madrid, Madrid, Spain