ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

Abstract Background Dolutegravir (DTG)-based antiretroviral therapy (ART) is highly effective and well-tolerated in adults and is rapidly being adopted globally. We describe the design of the ODYSSEY trial which evaluates the efficacy and safety of DTG-based ART compared with standard-of-care in chi...

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Bibliographic Details
Main Authors: Cecilia L. Moore, Anna Turkova, Hilda Mujuru, Adeodata Kekitiinwa, Abbas Lugemwa, Cissy M. Kityo, Linda N. Barlow-Mosha, Tim R. Cressey, Avy Violari, Ebrahim Variava, Mark F. Cotton, Moherndran Archary, Alexandra Compagnucci, Thanyawee Puthanakit, Osee Behuhuma, Yacine Saϊdi, James Hakim, Pauline Amuge, Lorna Atwine, Victor Musiime, David M. Burger, Clare Shakeshaft, Carlo Giaquinto, Pablo Rojo, Diana M. Gibb, Deborah Ford, the ODYSSEY Trial Team
Format: Article
Language:English
Published: BMC 2021-01-01
Series:BMC Infectious Diseases
Subjects:
Randomized control trial
Basket trial
HIV
Paediatric
Efficacy
Safety
Online Access:https://doi.org/10.1186/s12879-020-05672-6

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