Table 1 Summary of Experimental Regimens in MDR-TB Clinical Trials Underway or Planned
Trial Name (funding source) | Duration of Experimental Regimen (months) | Comparator | Experimental Arm(s) | GOAL | |||
|---|---|---|---|---|---|---|---|
| Â | Â | Â | Â | Shorten | All-oral | Improve tolerability | Improve cure rates |
C 213/Phase 3 Delamanid (Otsuka) | 24 | WHO Std | DLM + OBT | Â | Â | Â | X |
NeXT (MRC-SA) | 6-9 | SA Std | BDQ+LZD+LFX+ETA/INHH+PZA | X | X | Â | X |
endTB (PIH-MSF) | 9 | WHO Std (+/- new drug) | BDQ+LZD+MXF (HD)+PZA BDQ+CFZ+LZD+LFX+PZA DLM+LZD+MXF (HD)+PZA DLM+CFZ+LZD+LFX+PZA DLM+CFZ+MXF+PZA | X | X | X | X |
TB-PRACTECAL (MSF) | 6 | WHO Std (+/- new drug) | BDQ+PRT+LZD+MXF BDQ+PRT+LZD+CFZ BDQ+PRT+LZD | X | X | X | X |
STREAM Stage 1 (USAID+) | 9 | WHO Std | CFZ+EMB+MXF+PZA+4(KM+INHH+PTO) | X | Â | Â | X |
STREAM Stage 2 (USAID+) | 6: 9: | WHO Std 9 mo. Regimen | BDQ+LFX+CFZ+PZA+2(INHH+KM) BDQ+CFZ+EMB+LFX+PZA+4(INHH+PTO) | X | X | Â | X |
NC-005* (GATB) | 2 | None for MDR Arm | BDQ+PRT+MXF+PZA Note: this is a phase 2 study in DS & MDR-TB | X | X | X | X |
NiX-TB | 6-9 | None | BDQ+PRT+LZD | X | X | X | X |
STAND* (GATB) | 4-6 | None for MDR Arm | PRT+MXF+PZA | X | X | X | X |
Novartis | 24 | WHO Std | CFZ+OBT | Â | Â | Â | X |
Opti-Q | 6 | LFX 11 mg/kg + OBT | LFX 14, 17 ands 20 mg/kg (all + OBT) | Â | Â | Â | X |