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Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1–2 trial

Authors :
Ruel, Theodore D
Acosta, Edward P
Liu, Jessica P
Gray, Kathryn P
George, Kathleen
Montañez, Nicole
Popson, Stephanie
Buchanan, Ann M
Bartlett, Mattie
Dayton, Dale
Anthony, Patricia
Brothers, Cynthia
Vavro, Cynthia
Singh, Rajendra
Koech, Lucy
Vhembo, Tichaona
Mmbaga, Blandina T
Pinto, Jorge A
Dobbels, Els F M
Archary, Moherndran
Chokephaibulkit, Kulkanya
Ounchanum, Pradthana
Deville, Jaime G
Hazra, Rohan
Townley, Ellen
Wiznia, Andrew
Deville, Jaime G
Carter, Michele F
Mansky, Hannah
Pinto, Jorge A
Ferreira, Flavia F
Romeiro, Juliana
D'Angelo, Jessica
Williams, Ruth
Jundi, Fernanda
Cruz, Maria Letícia Santos
Sidi, Claude Leon
Kataike, Hajira
Owor, Maxensia
Ahimbisibwe, Grace Miriam
van Rensburg, Ms Anita Janse
Andrea, Catherine V
Ponatshego, Ponego L
Budu, Marian
Tirelo, Lesedi
Masheto, Gaerolwe R
Raesi, Mpho S.
Ramogodiri, Moakanyi
Chanthong, Jiraporn
Khamrong, Chintana
Aurpibul, Linda
Fairlie, Lee
Patel, Faeezah
Soma-Kashiram, Hamisha
Archary, Moherndran
Hanley, Sherika
Govender, Vani
Sturzbecher, Fernanda Tomé
Cervi, Maria Célia
Mmbaga, Blandina T
Njau, Boniface
Matibe, Petronilla
Mukonowenzou, Ruvimbo
Marozva, Catherine C
Keter, Winnie C
Bii, Priscilla C
Ounchanum, Pradthana
Cressey, Tim R
Sukrakanchana, Pra-ornsuda
Chokephaibulkit, Kulkanya
Rungmaitree, Supattra
Pilotto, Jose Henrique
Fernandes, Luis Eduardo
Gomes, Ivete Martins
Source :
The Lancet HIV; May 2022, Vol. 9 Issue: 5 pe332-e340, 9p
Publication Year :
2022

Abstract

Safe and potent antiretroviral medications in child-friendly formulations are needed to treat young children living with HIV-1. We aimed to select dosing for a dispersible tablet formulation of dolutegravir that achieved pharmacokinetic exposures similar to those in adults, and was safe and well tolerated in young children.

Details

Language :
English
ISSN :
24054704 and 23523018
Volume :
9
Issue :
5
Database :
Supplemental Index
Journal :
The Lancet HIV
Publication Type :
Periodical
Accession number :
ejs59525239
Full Text :
https://doi.org/10.1016/S2352-3018(22)00044-3