학술논문
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
Document Type
article
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; the ODYSSEY Trial Team
Source
BMC Infectious Diseases, Vol 21, Iss 1, Pp 1-14 (2021)
Subject
Language
English
ISSN
1471-2334
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