PanACEA has a strong history of well conducted clinical trials to evaluate new regimens for the treatment of drug sensitive TB. Our studies range from small two-center early Phase IIA studies through to large-scale Phase III studies in a multitude of sites and countries. At the start of the consortium, separate development programmes were conducted for each of the drugs in our portfolio (at the time moxifloxacin, rifampicin and SQ109). These programmes have since come together with a particular emphasis on regimen development and, introducing the Multi-Arm Multi-Stage (MAMS) study design, has set a new standard in TB combination therapy research, investigating all three drugs in different regimes in one trial. We continue to employ innovative methodology and biomarkers to design more efficient trials and speed the development of new regimens.

AcronymStudy ChairClinicalTrials.gov IdentifierFirst Patient RecruitedTotal PatientsDrugs/Regimens StudiedTrial Design
REMoxStephen GillespieNCT0086438318 January 20081931 patientsRapid Evaluation of Moxifloxacin in Tuberculosis in cooperation with GTBAPhase III
HR1Martin Boeree Rob Aarnoutse NCT0139291109 June 201168 patientsRapid Evaluation of High-Dose Rifampicin and other Rifamycins in TuberculosisPhase IIA
HR2Rob Aarnoutse Martin Boeree NCT0076014913 August 2010150 patientsRapid Evaluation of High-Dose Rifampicin and other Rifamycins in TuberculosisPhase IIB
SQ109 EBAMichael HölscherNCT01218217201090 patientsEvaluation of a Novel TB Drug (SQ109) to Shorten and Simplify Tuberculosis TreatmentPhase IIA
MAMS-TBMartin Boeree Michael HölscherNCT0178518607 May 2013365 PatientsA multiple arm, multiple stage (MAMS) trial to evaluate four treatment regimes including SQ109, two increased doses of rifampicin and moxifloxacinPhase IIB
HR1 ExtensionMartin Boeree Rob AarnoutseNCT01392911-30 patientsRapid Evaluation of High-Dose Rifampicin and other Rifamycins in TuberculosisPhase IIA
14 + 14 SMART Michael Hölscher Patrick Philips --Safety and efficacy assessment of Q203 and BTZ043Phase IIA
STEPMichael Hölscher--600 patientsRegimens including pyrazinamide and rifampicin at the optimized dose in addition to arms including optimized dose of Q203Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP) trial design

For more information on our studies, please search here: http://clinicaltrials.gov