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 Ongoing and Completed But Unpublished Phase IIa Studies (Extended Early Bactericidal Activity 14 Day End-Point).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