Research Papers

This database includes peer-reviewed publications authored by TB Alliance staff. Use the tags on the left to filter by subject, or search for a particular author or term using the search bar.

Tag: Clinical Development

Displaying 48 papers

Tuberculosis

Publication: Tuberculosis.Nature Reviews Disease Primers. 2016/10/27/online. 16076. Macmillan Publishers Limited. http://dx.doi.org/10.1038/nrdp.2016.76

Author(s): Pai, Madhukar; Behr, Marcel A.; Dowdy, David; Dheda, Keertan; Divangahi, Maziar; Boehme, Catharina C.; Ginsberg, Ann; Swaminathan, Soumya; Spigelman, Melvin; Getahun, Haileyesus; Menzies, Dick; Raviglione, Mario

10/2016

Tags: Clinical Development, Drug Discovery, MDR-TB, TB-HIV

Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials

Publication: Journal of Empirical Research on Human Research Ethics 1556264616657452, first published on June 30, 2016 doi:10.1177/1556264616657452

Author(s): Kathleen M. MacQueen, Natalie T. Eley, Mike Frick, Laia Ruiz Mingote, Alicia Chou, Stephanie S. Seidel, Stacey Hannah, and Carol Hamilton

6/2016

Tags: Advocacy, Clinical Development, Community Engagement, TB-HIV, Trial Design

Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials

Publication: Phillips PPJ, Mendel CM, Burger DA, et al. Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials. BMC Medicine. 2016 Mar.14:19. doi: 10.1186/s12916-016-0565-y

3/2016

Tags: Biomarkers, Clinical Development, Moxifloxacin, ReMoxTB, Trial Design

Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults

Publication: Furin J., Alirol E, Allen E, et. al. Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults. Int J Tuberc Lung Dis. 20161 Mar; 20(3): 290-294.

3/2016

Tags: Clinical Development, Editorials, MDR-TB, Trial Design, XDR-TB

Towards early inclusion of children in tuberculosis drugs trials: a consensus statement

Publication: Nachman S, Ahmed A, Amanullah, et. al. Towards early inclusion of children in tuberculosis drugs trials: a consensus statement. Lancet Infect Dis. 2015 Jun;15(6):711-20. doi: 10.1016/S1473-3099(15)00007-9.

5/2015

Tags: Advocacy, Childhood TB, Clinical Development, Editorials, Policy, Trial Design

Bactericidal Activity of Pyrazinamide and Clofazimine Alone and in Combinations with Pretomanid and Bedaquiline

Publication: Diacon AH, Dawson R, von Groote-Bidlingmaier F, et. al. Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline. Am J Respir Crit Care Med. 2015 Apr 15;191(8):943-53. doi: 10.1164/rccm.201410-1801OC.

4/2015

Tags: Bedaquiline (TMC-207), BPaZ, Clinical Development, Clinical Trial Results, Clofazamine, NC-003, Pretomanid/PA-824, Pyrazinamide, TB-HIV

Evaluation of moxifloxacin-containing regimens in pathologically distinct murine tuberculosis models

Publication: Li SY, Irwin SM, Converse PJ, Mdluli KE, Lenaerts AJ, Nuermberger EL. Evaluation of moxifloxacin-containing regimens in pathologically distinct murine tuberculosis models. Antimicrob Agents Chemother. 2015 Jul;59(7):4026-30. doi: 10.1128/AAC.00105-15.

4/2015

Tags: Clinical Development, HRZE, Moxifloxacin, Preclinical Data, Preclinical Models, ReMoxTB

Shorter moxifloxacin-based regimens for drug-sensitive tuberculosis

Publication: Alffenaar JW, Gumbo T, Aarnoutse R. Shorter moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2015 Feb 5;372(6):576. doi: 10.1056/NEJMc1414718#SA1.

2/2015

Tags: Clinical Development, Clinical Trial Results, HRZE, Moxifloxacin, ReMoxTB

The Tuberculosis Drug Discovery and Development Pipeline and Emerging Drug Targets

Publication: Mdluli K, Kaneko T, Upton A. The tuberculosis drug discovery and development pipeline and emerging drug targets.Cold Spring Harb Perspect Med. 2015 Jan 29;5(6). pii: a021154. doi: 10.1101/cshperspect.a021154.

1/2015

Tags: Advocacy, Clinical Development, Drug Discovery, Editorials, Global Pipeline, MDR-TB

Evaluation of the Pharmacokinetic Interaction between Repeated Doses of Rifapentine or Rifampin and a Single Dose of Bedaquiline in Healthy Adult Subjects

Publication: Winter H, Egizi E, Erondu N, et. al. Evaluation of the pharmacokinetic interaction between repeated doses of rifapentine or rifampin and a single dose of bedaquiline in healthy adult subjects. Antimicrob Agents Chemother. 2015 Feb;59(2):1219-24. doi: 10.1

12/2014

Tags: Bedaquiline (TMC-207), Clinical Development, Clinical Trial Results, Pharmacokinetics, Rifapentine

Rifampicin and rifapentine significantly reduce concentrations of bedaquiline, a new anti-TB drug

Publication: Svensson EM, Murray S, Karlsson MO, Dooley KE. Rifampicin and rifapentine significantly reduce concentrations of bedaquiline, a new anti-TB drug. J Antimicrob Chemother. 2015 Apr;70(4):1106-14. doi: 10.1093/jac/dku504.

12/2014

Tags: Bedaquiline (TMC-207), Clinical Development, Clinical Trial Results, Pharmacokinetics, Rifapentine

Strengthening neglected tropical disease research through enhancing research-site capacity: an evaluation of a novel web application to facilitate research collaborations

Publication: Furtado T, Franzen S, van Loggerenberg F, et. al. Strengthening neglected tropical disease research through enhancing research-site capacity: an evaluation of a novel web application to facilitate research collaborations. PLoS Negl Trop Dis. 2014 Nov 13;8

11/2014

Tags: Advocacy, Clinical Development, Editorials, Policy

Phase I safety, pharmacokinetics, and pharmacogenetics study of the antituberculosis drug PA-824 withconcomitant lopinavir-ritonavir, efavirenz, or rifampin

Publication: Dooley KE, Luetkemeyer AF, Park JG, et. al. Phase I safety, pharmacokinetics, and pharmacogenetics study of the antituberculosis drug PA-824 with concomitant lopinavir-ritonavir, efavirenz, or rifampin. Antimicrob Agents Chemother. 2014 Sep;58(9):5245-52.

9/2014

Tags: Clinical Development, Clinical Trial Results, Pharmacokinetics, Pretomanid/PA-824, TB-HIV

Four-Month Moxifloxacin-Based Regimens for Drug-Sensitive Tuberculosis

Publication: Gillespie SH, Crook AM, McHugh TD, et. al. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2014 Oct 23;371(17):1577-87. doi: 10.1056/NEJMoa1407426.

4/2014

Tags: Clinical Development, Clinical Trial Results, HRZE, Moxifloxacin, ReMoxTB

Effect of a high-calorie, high-fat meal on the bioavailability and pharmacokinetics of PA-824 in healthy adult subjects

Publication: Winter H, Ginsberg A, Egizi E, et. al. Effect of a High-Calorie, High-Fat Meal on the Bioavailability and Pharmacokinetics of PA-824 in Healthy Adult Subjects. Antimicrob Agents Chemother. 2013 Nov; 57(11): 5516–5520. doi: 10.1128/AAC.00798-13

11/2013

Tags: Clinical Development, Clinical Trial Results, Pharmacodynamics, Pretomanid/PA-824

Requirements for the clinical evaluation of new anti-tuberculosis agents in children

Publication: Donald PR, Ahmed A, Burman WJ, et. al. Requirements for the clinical evaluation of new anti-tuberculosis agents in children. Int J Tuberc Lung Dis. 2013 Jun;17(6):794-9. doi: 10.5588/ijtld.12.0567.

6/2013

Tags: Advocacy, Childhood TB, Clinical Development, Editorials, Trial Design

Randomized dose-ranging study of the 14-day early bactericidal activity of bedaquiline (TMC207) in patients withsputum microscopy smear-positive pulmonary tuberculosis

Publication: Diacon AH, Dawson R, Von Groote-Bidlingmaier F, et. al. Randomized Dose-Ranging Study of the 14-Day Early Bactericidal Activity of Bedaquiline (TMC207) in Patients with Sputum Microscopy Smear-Positive Pulmonary Tuberculosis. Antimicrob Agents Chemother.

5/2013

Tags: Bedaquiline (TMC-207), Clinical Development, Clinical Trial Results, Pharmacokinetics

Evaluation of pharmacokinetic interaction between PA-824 and midazolam in healthy adult subjects

Publication: Winter H, Egizi E, Erondu N, et. al. Evaluation of Pharmacokinetic Interaction between PA-824 and Midazolam in Healthy Adult Subjects. Antimicrob Agents Chemother. 2013 Aug; 57(8): 3699–3703.doi: 10.1128/AAC.02632-12

4/2013

Tags: Clinical Development, Clinical Trial Results, Pretomanid/PA-824

Early bactericidal activity of new drug regimens for tuberculosis - Authors' reply

Publication: Diacon AH, Donald PR, Mendel CM. Early bactericidal activity of new drug regimens for tuberculosis - Authors' reply. Lancet. 2013 Jan 12;381(9861):112-3. doi: 10.1016/S0140-6736(13)60042-2.

1/2013

Tags: Clinical Development, Editorials, Moxifloxacin, NC-001, PaMZ, Pretomanid/PA-824, Pyrazinamide, Trial Design

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