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. Author manuscript; available in PMC: 2014 Mar 28.
Published in final edited form as: Curr Respir Med Rev. 2013 Jun 1;9(3):200–210. doi: 10.2174/1573398x113099990017

Table 2. Ongoing and Completed But Unpublished Phase IIa Studies (Extended Early Bactericidal Activity 14 Day End-Point).

Drug Classes Study Sites Recruitment Groups Regimens Primary End-Point(s)
Q ACTG
NCT01589497
S Africa DS-TB
HIV−/+(CD4>200/μl)
2 days RHZE →12 days REZ
2 days RHZE → 12 days RMZE 14 days RHZE
Rate of change in log10 CFU/ml in sputum from day 2-14
D N Global Alliance
NCT01691534
S Africa DS-TB
HIV−/+
14 days JPaZC, JPaZ, JPaC, JZC, Z, C or RHZE Rate of change in log10 CFU/ml in sputum from day 0-14
N Global Alliance
NCT00944021
S Africa DS-TB
HIV−/+(CD4>300/μl)
14 days Pa50, Pa100, Pa150, Pa200 or RHZE Rate of change in log10 CFU/ml in sputum from day 0-14
N Otsuka
NCT00401271
S Africa DS-TB
HIV−/+(CD4>350/μl)
14 days D100, D200, D300, D400 or RHZE Rate of change in log10 CFU/ml in sputum from day 0-14
Ox Pfizer
NCT01225640
S Africa DS-TB
HIV −/+(CD4>350/μl)
14 days Su60, Su1200 or RHZE Rate of change in log10 CFU/ml in sputum from day 0-2
Ox NIAID
NCT01516203
S Africa DS-TB
HIV−/+(CD4>350/μl)
14 days of Po500od, Po500bid, Po800bid, Po 1200bid or RHZE Rate of change in log10 CFU/ml in sputum from day 0-14
Ed Sequella
NCT01218217
S Africa DS-TB
HIV−/+(CD4>250/μl)
14 days of Sq75, Sq150, Sq300, Sq150R or R Rate of change in log10 CFU/ml in sputum from day 0-14

Drug classes are coded as in Table 1: Q=fluoroquinolones, D=Diarlyquinoline, N=nitroimidazopyran, Ox=Oxazolidinones, Ed=Ethylenediamines Numbers before drug regimens specify duration in months. Drugs are coded with the following initials: R=Rifampicin, H=Izoniazid, Z=Pyrazinamide, E=Ethambutol,M=Moxifloxacin, J=Bedaquiline, Pa=PA-824, C=Clofazimine, D=Delamanid, Su=Sutezolid,Sq=SQ109. Varying dosages of a drug in different arms of a trial, are indicated by a subscript next to the drug initial, bid=twice daily.