Tanneau, Lénaïg
Karlsson, Mats O.
Diacon, Andreas H.
Shenje, Justin
De Los Rios, Jorge
Wiesner, Lubbe
Upton, Caryn M.
Dooley, Kelly E.
Maartens, Gary
Svensson, Elin M. http://orcid.org/0000-0002-0093-6445
Funding for this research was provided by:
Foundation for the National Institutes of Health
National Institute of Allergy and Infectious Diseases (UM1 AI068634, UM1 AI068636, UM1 AI106701, K24AI150349)
Article History
Accepted: 27 April 2022
First Online: 7 June 2022
Declarations
:
: This analysis was funded by the Division of AIDS at the National Institutes of Health (NIH). The University of Cape Town Clinical PK Laboratory is supported in part via the Adult Clinical Trial Group (ACTG), by the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH under award numbers UM1 AI068634, UM1 AI068636, and UM1 AI106701. KED is supported by K24AI150349 from the NIAID, NIH.
: LT, MOK, AHD, JS, JDLR, LW, CMU, KED, GM, and EMS have no conflicts of interest to declare.
: The clinical data were available from both the DELIBERATE trial (NCT02583048) and the report of the results of the clinical trial already published [CitationRef removed]. The trial was approved by the local Ethics Committees at each site, and participants gave written informed consent.
: Not applicable.
: Deidentified participant data were shared to the modeler. Top-line study results have already been published [CitationRef removed]. The final model NONMEM code for delamanid and DM-6705 PK can be found in the electronic supplementary material.
: LT, MOK and EMS designed the research in conjunction with AHD, KED and GM; AHD, JS, JDLR and CMU conducted the clinical trial; LW analyzed the PK samples; LT performed the posterior data management, the analysis and wrote the first draft of the manuscript; and MOK and EMS reviewed and supervised the analysis and the manuscript preparation. All authors reviewed the key steps of the analysis and commented on intermediate versions of the manuscript, and read and approved the final manuscript.