Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB. We nested a two-period, fixed-order pharmacokinetic substudy w...

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Veröffentlicht in:The lancet HIV 2022-09, Vol.9 (9), p.e627-e637
Hauptverfasser: Turkova, Anna, Waalewijn, Hylke, Chan, Man K, Bollen, Pauline D J, Bwakura-Dangarembizi, Mutsa F, Kekitiinwa, Adeodata R, Cotton, Mark F, Lugemwa, Abbas, Variava, Ebrahim, Ahimbisibwe, Grace Miriam, Srirompotong, Ussanee, Mumbiro, Vivian, Amuge, Pauline, Zuidewind, Peter, Ali, Shabinah, Kityo, Cissy M, Archary, Moherndran, Ferrand, Rashida A, Violari, Avy, Gibb, Diana M, Burger, David M, Ford, Deborah, Colbers, Angela
Format: Artikel
Sprache:eng
Schlagworte:
Adolescent
Child
Child, Preschool
Female
Heterocyclic Compounds, 3-Ring
HIV Infections - complications
HIV Infections - drug therapy
HIV-1
Humans
Infant
Life Sciences
Male
Oxazines
Piperazines
Pyridones
Rifampin - adverse effects
Tuberculosis - complications
Tuberculosis - drug therapy
Uganda
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Zusammenfassung:Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB. We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. Children (aged 4 weeks to
ISSN:2352-3018
2405-4704
2352-3018
DOI:10.1016/S2352-3018(22)00160-6