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Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission.
Lindsey JC, Hughes MD, Violari A, Eshleman SH, Abrams EJ, Bwakura-Dangarembizi M, Barlow-Mosha L, Kamthunzi P, Sambo PM, Cotton MF, Moultrie H, Khadse S, Schimana W, Bobat R, Zimmer B, Petzold E, Mofenson LM, Jean-Philippe P, Palumbo P; P1060 Study Team. Lindsey JC, et al. Pediatr Infect Dis J. 2014 Aug;33(8):846-54. doi: 10.1097/INF.0000000000000337. Pediatr Infect Dis J. 2014. PMID: 25222305 Free PMC article. Clinical Trial.
CYP2B6 genotype-directed dosing is required for optimal efavirenz exposure in children 3-36 months with HIV infection.
Bolton Moore C, Capparelli EV, Samson P, Bwakura-Dangarembizi M, Jean-Philippe P, Worrell C, Heckman B, Purdue L, Spector SA, Benns A, Borkowsky W, Loftis A, Hawkins E, Wallis C, Chadwick EG; IMPAACT P1070 team. Bolton Moore C, et al. AIDS. 2017 May 15;31(8):1129-1136. doi: 10.1097/QAD.0000000000001463. AIDS. 2017. PMID: 28323755 Free PMC article.
Neuropsychological performance in African children with HIV enrolled in a multisite antiretroviral clinical trial.
Boivin MJ, Barlow-Mosha L, Chernoff MC, Laughton B, Zimmer B, Joyce C, Bwakura-Dangarembizi M, Ratswana M, Abrahams N, Fairlie L, Gous H, Kamthunzi P, McCarthy K, Familiar-Lopez I, Jean-Phillippe P, Coetzee J, Violari A, Cotton MF, Palumbo PE; IMPAACT P1104s Study Team. Boivin MJ, et al. AIDS. 2018 Jan 14;32(2):189-204. doi: 10.1097/QAD.0000000000001683. AIDS. 2018. PMID: 29112069 Free PMC article.
Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV.
Ford D, Turner R, Turkova A, Penazzato M, Musiime V, Bwakura-Dangarembizi M, Violari A, Chabala C, Puthanakit T, Sudjaritruk T, Cressey TR, Lallemant M, Gibb DM. Ford D, et al. J Acquir Immune Defic Syndr. 2018 Aug 15;78 Suppl 1(1):S40-S48. doi: 10.1097/QAI.0000000000001748. J Acquir Immune Defic Syndr. 2018. PMID: 29994919 Free PMC article.
Establishing Dosing Recommendations for Efavirenz in HIV/TB-Coinfected Children Younger Than 3 Years.
Bwakura Dangarembizi M, Samson P, Capparelli EV, Moore CB, Jean-Philippe P, Spector SA, Chakhtoura N, Benns A, Zimmer B, Purdue L, Jackson C, Wallis C, Libous JL, Chadwick EG; IMPAACT P1070 Study Team. Bwakura Dangarembizi M, et al. J Acquir Immune Defic Syndr. 2019 Aug 1;81(4):473-480. doi: 10.1097/QAI.0000000000002061. J Acquir Immune Defic Syndr. 2019. PMID: 31241542 Free PMC article. Clinical Trial.
Pharmacokinetics and safety of early nevirapine-based antiretroviral therapy for neonates at high risk for perinatal HIV infection: a phase 1/2 proof of concept study.
Ruel TD, Capparelli EV, Tierney C, Nelson BS, Coletti A, Bryson Y, Cotton MF, Spector SA, Mirochnick M, LeBlanc R, Reding C, Zimmer B, Persaud D, Bwakura-Dangarembizi M, Naidoo KL, Hazra R, Jean-Philippe P, Chadwick EG. Ruel TD, et al. Lancet HIV. 2021 Mar;8(3):e149-e157. doi: 10.1016/S2352-3018(20)30274-5. Epub 2020 Nov 23. Lancet HIV. 2021. PMID: 33242457 Free PMC article. Clinical Trial.
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.
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.
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