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

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

Published:2022-05 Issue:5 Volume:9 Page:e332-e340
ISSN:2352-3018
Container-title:The Lancet HIV
language:en
Short-container-title:The Lancet HIV

Author:

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

Publisher

Elsevier BV

Subject

Virology,Infectious Diseases,Immunology,Epidemiology

Reference17 articles.

1. Safety, pharmacokinetics and efficacy of dolutegravir in treatment-experienced HIV-1 infected adolescents: forty-eight-week results from IMPAACT P1093;Viani;Pediatr Infect Dis J,2015

2. A sensitive HPLC-MS/MS method for the determination of dolutegravir in human plasma;Bennetto-Hood;J Chromatogr B Analyt Technol Biomed Life Sci,2014

3. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study;Cahn;Lancet,2013

4. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study;Raffi;Lancet,2013

5. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial;van Lunzen;Lancet Infect Dis,2012

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1. Twice-Daily Dosing of Dolutegravir in Infants on Rifampicin Treatment: A Pharmacokinetic Substudy of the EMPIRICAL Trial;Clinical Infectious Diseases;2023-10-26

2. Updates in the Approach to Pediatric HIV Care and Prevention;Current Treatment Options in Pediatrics;2023-10-13

3. Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial;The Lancet Child & Adolescent Health;2023-10

4. Population Pharmacokinetic Modeling of Dolutegravir to Optimize Pediatric Dosing in HIV-1-Infected Infants, Children, and Adolescents;Clinical Pharmacokinetics;2023-08-21

5. Pharmacokinetics, safety, and tolerability of dispersible and immediate-release abacavir, dolutegravir, and lamivudine tablets in children with HIV (IMPAACT 2019): week 24 results of an open-label, multicentre, phase 1–2 dose-confirmation study;The Lancet HIV;2023-08