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Clinical Trial Update: Needs and Progress
Clinical Trial Update: Needs and Progress
Prevalence of
MDR-TB
among
previously
treated TB
cases
480,000 MDR among new TB Cases
111,000 (23%)
11.5% expected
treated success
70%
60% 62% 62%
55% 54% 56%
50% 50%
outcome
40%
30% 32%
20%
10%
0%
1 2 3 4 5 6 7
Reference
1WHO Global Report, 2014; 2Orenstein, Lancet, 2009*; 3Johnston, PLoS,
2009*; 4Diacon, NEJM, 2014; 5Skriponoca, ERJ, 2013; 6Ahuja, PLoS, 2012*;
7Bonnet et al, IJTLD, 2016
Frequency of adverse events (or AE indicating
drug removal) on existing MDR-TB treatment
100
90
80
70
60
50
40
30
20
10
Nix-TB: BDQ, pretomanid, and linezolid in patients Currently recruiting in S. Africa 3 NCT02333799
with XDR-TB 6-9 months
GATB NC-005: Combinations of BDQ, MFX, PA- Currently recruiting in Africa 2 NCT02193776
824, & PZA for 8 weeks for DS- & MDR-TB
STAND: MFX, PA-824, & PZA DS- & MDR-TB Suspended 3 NCT02342886
Linezolid and clarithromycin drug-interaction (PK) Completed 4 NCT01521364
in MDR- & XDR-TB
DDI (PK) & combined QT effects of BDQ and Expected to begin enrolling 2 NCT02583048
DLM in MDR-TB 2Q16 in S. Africa
9
Safety & efficacy study of DLM (Confirmatory) Study completed 3 NCT01424670
DRUG-RESISTANT TUBERCULOSIS
CLINICAL TRIALS PROGRESS REPORT
Arm 1
Arm 2
Regimen
Regimen
Arm 3
Arm 4
Treatment effect Treatment effect
Arm 5
Arm 6
Expansion of trial capacity: endTB trial sites
* *
*