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Start Over Author "Alexandra Compagnucci" Journal bmc infectious diseases
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1. 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

Author

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, and the ODYSSEY Trial Team

Subjects
Randomized control trial, Basket trial, HIV, Paediatric, Efficacy, Safety, Infectious and parasitic diseases, RC109-216
Abstract

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 children and adolescents. The ODYSSEY trial includes nested pharmacokinetic (PK) sub-studies which evaluated pragmatic World Health Organization (WHO) weight-band-based DTG dosing and opened recruitment to children

Published
2021
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