Browsing by Author "Aarnoutse, Rob E."
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- ItemAfri-Can Forum 2(Biomed Central, 2016-07-12) Mukudu, Hillary; Martinson, Neil; Sartorius, Benn; Coetzee, Jenny; Dietrich, Janan; Mokgatswana, Kgaugelo; Jewkes, Rachel; Gray, Glenda E.; Dugas, Marylene; Behanzin, Luc; Guedou, Fernand A.; Gagnon, Marie-Pierre; Alary, Michel; Rutakumwa, Rwamahe; Mbonye, Martin; Kiwanuka, Thadeus; Nakamanya, Sarah; Muhumuza, Richard; Nalukenge, Winfred; Seeley, Janet; Atujuna, Millicent; Wallace, Melissa; Brown, Ben; Bekker, Linda G.; Newman, Peter A.; Harryparsad, Rushil; Olivier, Abraham J.; Jaspan, Heather B.; Wilson, Douglas; Dietrich, Janan; Martinson, Neil; Mukudu, Hillary; Mkhize, Nonhlanhla; Morris, Lynn; Cianci, Gianguido; Dinh, Minh; Hope, Thomas; Passmore, Jo-Ann S.; Gray, Clive M.; Henrick, Bethany M.; Yao, Xiao-Dan; Rosenthal, Kenneth L.; Henrick, Bethany M.; Yao, Xiao-Dan; Drannik, Anna G.; Rosenthal, Kenneth L.; Chanzu, Nadia; Mwanda, Walter; Oyugi, Julius; Anzala, Omu; Mbow, Moustapha; Jallow, Sabelle; Thiam, Moussa; Davis, Alberta; Diouf, Assane; Ndour, Cheikh T.; Seydi, Moussa; Dieye, Tandakha N.; Mboup, Souleymane; Goodier, Martin; Rilley, Eleanor; Jaye, Assan; Yao, Xiao-Dan; Omange, R. W.; Henrick, Bethany M.; Lester, Richard T.; Kimani, Joshua; Ball, T. B.; Plummer, Francis A.; Rosenthal, Kenneth L.; Behanzin, Luc; Guedou, Fernand A.; Geraldo, Nassirou; Mastetse, Ella G.; Sossa, Jerome C.; Zannou, Marcel D.; Alary, Michel; Osawe, Sophia; Okpokoro, Evaezi; Okolo, Felicia; Umaru, Stephen; Abimiku, Rebecca; Audu, Sam; Datong, Pam; Abimiku, Alashle; Nyange, Jacquelyn; Olenja, Joyce; Mutua, Gaudensia; Jaoko, Walter; Omosa-Manyonyi, Gloria; Farah, Bashir; Khaniri, Maureen; Anzala, Omu; Cockcroft, Anne; Tonkin, Kendra; Girish, Indu; Mhati, Puna; Cunningham, Ashley; Andersson, Neil; Farah, Bashir; Indangasi, Jackton; Jaoko, Walter; Mutua, Gaudensia; Khaniri, Maureen; Nyange, Jacquelyn; Anzala, Omu; Diphoko, Thabo; Gaseitsiwe, Simani; Maiswe, Victoria; Iketleng, Thato; Maruapula, Dorcas; Bedi, Keabetswe; Moyo, Sikhulile; Musonda, Rosemary; Wainberg, Mark; Makhema, Joseph; Novitsky, Vladimir; Marlink, Richard; Essex, Max; Okoboi, Stephen; Ssali, Livingstone; Kalibala, Sam; Birungi, Josephine; Egessa, Aggrey; Wangisi, Jonathan; Okullu, Lyavala J.; Bakanda, Celestin; Obare, Francis; Boer, I. M. S.; Semvua, Hadija H.; Van den Boogaard, Jossy; Kiwango, Krisanta W.; Ngowi, Kennedy M.; Nieuwkerk, Pythia T.; Aarnoutse, Rob E.; Kiwelu, Ireen; Muro, Eva; Kibiki, Gibson S.; Datiri, Ruth; Choji, Grace; Osawe, Sophia; Okpokoro, Evaezi; Okolo, Felicia; Umaru, Stephen; Abimiku, Rebecca; Datong, Pam; Abimiku, Alashle; Fomsgaard, A.; Karlsson, I.; Jensen, K. J; Jensen, S. S.; Leo-Hansen, C.; Jespersen, S.; Da Silva Te, D.; Rodrigues, C. M.; Da Silva, Z. J.; Janitzek, C. M.; Gerstoft, J.; Kronborg, G.; Okpokoro, Evaezi; Osawe, Sophia; Daitiri, Ruth; Choji, Grace; Umaru, Stephen; Okolo, Felicia; Datong, Pam; Emily, Nyariki; Joyce, Olenja; Robert, Lorway R.; Anzala, Anzala; Viljoen, Katie; Wendoh, Jerome; Kidzeru, Elvis; Karaoz, Ulas; Brodie, Eoin; Botha, Gerrit; Mulder, Nicola; Gray, Clive; Cameron, William; Stintzi, Alain; Jaspan, Heather; Levett, Paul N.; Alexander, David; Gulzar, Naveed; Grewal, Prabvir S.; Poon, Art F Y.; Brumme, Zabrina; Harrigan, P. R.; Brooks, James I.; Sandstrom, Paul A.; Calvez, Stryker; Sanche, Stephen E.; Scott, Jamie K.; Swartz, Leslie; Kagee, Ashraf; Lesch, Anthea; Kafaar, Zuhayr; De Wet, Anneliese; Okpokoro, Evaezi; Osawe, Sophia; Daitiri, Ruth; Choji, Grace; Umaru, Stephen; Okolo, Felicia; Datong, Pam; Abimiku, Alashle; Dietrich, Janan; Smith, Tricia; Cotton, Laura; Hornschuh, Stefanie; Van der Watt, Martin; Miller, Cari L.; Gray, Glenda; Smit, Jenni; Jaggernath, Manjeetha; Ndungu, Thumbi; Brockman, Mark; Kaida, Angela; Akolo, Maureen; Kimani, Joshua; Gelmon, Larry; Chitwa, Michael; Osero, Justus; Cockcroft, Anne; Marokoane, Nobantu; Kgakole, Leagajang; Maswabi, Boikhutso; Mpofu, Neo; Ansari, Umaira; Andersson, Neil; Nakinobe, Elizabeth; Miiro, George M.; Zalwango, Flavia; Nakiyingi-Miiro, Jessica; Kaleebu, Potiano; Semwanga, John R.; Nyanzi, Emily; Musoke, Saidat N.; Nakinobe, Elizabeth; Miiro, George; Mbidde, Edward K.; Lutalo, Tom; Kaleebu, Pontiano; Handema, Ray; Chianzu, Graham P.; Thiam, Moussa; Diagne-Gueye, Diabou; Ndiaye, Mame K.; Mbow, Moustapha; Ndiaye, Birahim P.; Traore, Ibrahima; Dia, Mamadou C.; Thomas, Gilleh; Tour-Kane, Coumba; Mboup, Souleymane; Jaye, Assan; Nyanzi, Emily; Mbidde, Edward K.; Kaleebu, Pontiano; Mpendo, Juliet; Kimani, Joshua; Birungi, Josephine; Muyindike, Winnie; Kambugu, Andrew; Sebastian, Hachizovu; Ray, Handema; Mike, Chaponda; Bertin, Kabuya J.; Modest, Mulenga; Thiam, Moussa; Janha, Omar; Davis, Alberta; Amambua-Ngwa, Alfred; Nwakanma, Davis C.; Mboup, Souleymane; Jaye, Assan; Jespersen, Sanne; Hønge, Bo L.; Esbjornsson, Joakim; Medina, Candida; Te, David Da Silva; Correira, Faustino G.; Laursen, Alex L.; Ostergaard, Lars; Andersen, Andreas; Aaby, Peter; Erikstrup, Christian; Wejse, Christian; Dieye, Siry; Sarr, Moussa; Sy, Haby; Mbodj, Helene D.; Ndiaye, Marianne; Ndiaye, Amy; Moussa, Seydi; Jaye, Assan; Mboup, Souleymane; Nyombi, Balthazar M.; Shao, Elichilia R.; Chilumba, Innocent B.; Moyo, Sikhulile; Gaseitsiwe, Simani; Musonda, Rosemary; Datong, Pam; Inyang, Bucky; Osawe, Sophia; Izang, Abel; Cole, Chundung; Okolo, Felicia; Cameron, Bill; Rosenthal, Kenneth; Gray, Clive; Jaspan, Heather; Seraise, Boitumelo; Andrea-Marobela, Kerstin; Moyo, Sikhulile; Musonda, Rosemary; Makhema, Joseph; Essex, Max; Gaseitsiwe, SimaniENGLISH ABSTRACT: We are pleased to present peer reviewed forum proceedings of the 2nd synchronicity forum of GHRI/CHVIfunded Canadian and African HIV prevention and vaccine teams Forum objectives ∙GHRI-funded capacity building and HIV prevention research teams presented highlights of achievements ∙Teams discussed how to jointly build on achievements for sustainability ∙Provided an opportunity for inter-team collaboration, synchronize best approach to capacity building, mentoring of new researchers and building leadership ∙Provided opportunities for informal discussions and networking among the teams. ∙Teams learnt about recent advances in the area of African regulatory and ethics review process ∙The forum proceedings was a special supplement in an openaccess journal was produced
- ItemA new trial design to accelerate tuberculosis drug development : the Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP)(BioMed Central, 2016-03-23) Phillips, Patrick P. J.; Dooley, Kelly E.; Gillespie, Stephen H.; Heinrich, Norbert; Stout, Jason E.; Nahid, Payam; Diacon, Andreas H.; Aarnoutse, Rob E.; Kibiki, Gibson S.; Boeree, Martin J.; Hoelscher, MichaelBackground: The standard 6-month four-drug regimen for the treatment of drug-sensitive tuberculosis has remained unchanged for decades and is inadequate to control the epidemic. Shorter, simpler regimens are urgently needed to defeat what is now the world’s greatest infectious disease killer. Methods: We describe the Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP) as a novel hybrid phase II/III trial design to accelerate regimen development. In the Phase IIC STEP trial, the experimental regimen is given for the duration for which it will be studied in phase III (presently 3 or 4 months) and patients are followed for clinical outcomes of treatment failure and relapse for a total of 12 months from randomisation. Operating characteristics of the trial design are explored assuming a classical frequentist framework as well as a Bayesian framework with flat and sceptical priors. A simulation study is conducted using data from the RIFAQUIN phase III trial to illustrate how such a design could be used in practice. Results: With 80 patients per arm, and two (2.5 %) unfavourable outcomes in the STEP trial, there is a probability of 0.99 that the proportion of unfavourable outcomes in a potential phase III trial would be less than 12 % and a probability of 0.91 that the proportion of unfavourable outcomes would be less than 8 %. With six (7.5 %) unfavourable outcomes, there is a probability of 0.82 that the proportion of unfavourable outcomes in a potential phase III trial would be less than 12 % and a probability of 0.41 that it would be less than 8 %. Simulations using data from the RIFAQUIN trial show that a STEP trial with 80 patients per arm would have correctly shown that the Inferior Regimen should not proceed to phase III and would have had a high chance (0.88) of either showing that the Successful Regimen could proceed to phase III or that it might require further optimisation. Conclusions: Collection of definitive clinical outcome data in a relatively small number of participants over only 12 months provides valuable information about the likelihood of success in a future phase III trial. We strongly believe that the STEP trial design described herein is an important tool that would allow for more informed decision-making and accelerate regimen development.