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Page 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.
Moore CL, Turkova A, Mujuru H, Kekitiinwa A, Lugemwa A, Kityo CM, Barlow-Mosha LN, Cressey TR, Violari A, Variava E, Cotton MF, Archary M, Compagnucci A, Puthanakit T, Behuhuma O, Saϊdi Y, Hakim J, Amuge P, Atwine L, Musiime V, Burger DM, Shakeshaft C, Giaquinto C, Rojo P, Gibb DM, Ford D; ODYSSEY Trial Team. Moore CL, et al. BMC Infect Dis. 2021 Jan 4;21(1):5. doi: 10.1186/s12879-020-05672-6. BMC Infect Dis. 2021. PMID: 33446115 Free PMC article. Clinical Trial.
Use of WHO paediatric weight-band dosing in drug labels.
Jacobs TG, Waalewijn H, Colbers A. Jacobs TG, et al. Among authors: waalewijn h. Lancet HIV. 2022 Jan;9(1):e3-e4. doi: 10.1016/S2352-3018(21)00277-0. Epub 2021 Dec 6. Lancet HIV. 2022. PMID: 34883067 No abstract available.
Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children.
Turkova A, White E, Mujuru HA, Kekitiinwa AR, Kityo CM, Violari A, Lugemwa A, Cressey TR, Musoke P, Variava E, Cotton MF, Archary M, Puthanakit T, Behuhuma O, Kobbe R, Welch SB, Bwakura-Dangarembizi M, Amuge P, Kaudha E, Barlow-Mosha L, Makumbi S, Ramsagar N, Ngampiyaskul C, Musoro G, Atwine L, Liberty A, Musiime V, Bbuye D, Ahimbisibwe GM, Chalermpantmetagul S, Ali S, Sarfati T, Wynne B, Shakeshaft C, Colbers A, Klein N, Bernays S, Saïdi Y, Coelho A, Grossele T, Compagnucci A, Giaquinto C, Rojo P, Ford D, Gibb DM; ODYSSEY Trial Team. Turkova A, et al. N Engl J Med. 2021 Dec 30;385(27):2531-2543. doi: 10.1056/NEJMoa2108793. N Engl J Med. 2021. PMID: 34965338 Free PMC article. Clinical Trial.
Dolutegravir dosing for children with HIV weighing less than 20 kg: pharmacokinetic and safety substudies nested in the open-label, multicentre, randomised, non-inferiority ODYSSEY trial.
Waalewijn H, Chan MK, Bollen PDJ, Mujuru HA, Makumbi S, Kekitiinwa AR, Kaudha E, Sarfati T, Musoro G, Nanduudu A, Lugemwa A, Amuge P, Moore CL, Rojo P, Giaquinto C, Colbers A, Gibb DM, Ford D, Turkova A, Burger DM; ODYSSEY Trial Team. Waalewijn H, et al. Lancet HIV. 2022 May;9(5):e341-e352. doi: 10.1016/S2352-3018(21)00292-7. Epub 2022 Feb 18. Lancet HIV. 2022. PMID: 35189082 Free PMC article.
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.
Turkova A, Waalewijn H, Chan MK, Bollen PDJ, Bwakura-Dangarembizi MF, Kekitiinwa AR, Cotton MF, Lugemwa A, Variava E, Ahimbisibwe GM, Srirompotong U, Mumbiro V, Amuge P, Zuidewind P, Ali S, Kityo CM, Archary M, Ferrand RA, Violari A, Gibb DM, Burger DM, Ford D, Colbers A; ODYSSEY Trial Team. Turkova A, et al. Among authors: waalewijn h. Lancet HIV. 2022 Sep;9(9):e627-e637. doi: 10.1016/S2352-3018(22)00160-6. Epub 2022 Jul 19. Lancet HIV. 2022. PMID: 35868341 Free PMC article. Clinical Trial.
Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial.
Amuge P, Lugemwa A, Wynne B, Mujuru HA, Violari A, Kityo CM, Archary M, Variava E, White E, Turner RM, Shakeshaft C, Ali S, Nathoo KJ, Atwine L, Liberty A, Bbuye D, Kaudha E, Mngqibisa R, Mosala M, Mumbiro V, Nanduudu A, Ankunda R, Maseko L, Kekitiinwa AR, Giaquinto C, Rojo P, Gibb DM, Turkova A, Ford D; ODYSSEY Trial Team. Amuge P, et al. Lancet HIV. 2022 Sep;9(9):e638-e648. doi: 10.1016/S2352-3018(22)00163-1. Lancet HIV. 2022. PMID: 36055295 Free PMC article. Clinical Trial.
Pharmacokinetic Data of Dolutegravir in Second-line Treatment of Children With Human Immunodeficiency Virus: Results From the CHAPAS4 Trial.
Bevers LAH, Waalewijn H, Szubert AJ, Chabala C, Bwakura-Dangarembizi M, Makumbi S, Nangiya J, Mumbiro V, Mulenga V, Musiime V, Burger DM, Gibb DM, Colbers A. Bevers LAH, et al. Among authors: waalewijn h. Clin Infect Dis. 2023 Nov 11;77(9):1312-1317. doi: 10.1093/cid/ciad346. Clin Infect Dis. 2023. PMID: 37280040 Free PMC article. Clinical Trial.
18 results