Table 1.
Baseline Characteristics of the Study Participants in the Pooled Data Sets
| Trial* (Ref) | Rifapentine Regimen | N Individuals (N Samples) | Age (yr) | Weight (kg) | Female Sex | HIV-Positive |
|---|---|---|---|---|---|---|
| Analysis cohort | ||||||
| 06–0050 (19) | 900 mg thrice weekly with low-fat meal | 14 (269) | 41 (24–64) | 76 (50–97) | 3 (21.4) | — |
| Phase 1 | ||||||
| HV | ||||||
| PM | ||||||
| RIFAQUIN (12) | 900 mg twice weekly or 1,200 mg once weekly with high-fat meal | 241 (846) | 32 (18–80) | 56 (38–78) | 88 (36.5) | 46 (19.1) |
| Phase 3 | ||||||
| DS-TB | ||||||
| PM | ||||||
| TBTC-29B (14) | 5–20 mg/kg once daily with low-fat meal | 26 (504) | 47 (24–60) | 82 (60–99) | 5 (19.2) | — |
| Phase 1 | ||||||
| HV | ||||||
| Rifapentine, Mdz | ||||||
| TBTC-25 (29) | 600, 900, or 1,200 mg once weekly on empty stomach | 35 (357) | 44 (18–68) | 65 (46–110) | 12 (34.3) | — |
| Phase 2 | ||||||
| DS-TB | ||||||
| PH | ||||||
| ACTG-A5311 (21) | 10 mg/kg twice daily or 15 or 20 mg/kg once daily with low- or high-fat meal | 44 (1,210) | 35 (20–59) | 82 (60–99) | 12 (27.3) | — |
| Phase 1 | ||||||
| HV | ||||||
| Rifapentine | ||||||
| Validation cohort | ||||||
| TBTC-29X (28) | 10, 15, or 20 mg/kg once daily with high-fat meal | 225 (713) | 30 (18–70) | 55 (40–83) | 66 (29.3) | 19 (8.4) |
| Phase 2 | ||||||
| DS-TB | ||||||
| PHZE | ||||||
| TBTC-26 (30) | 900 mg once weekly with food | 77 (77) | 40 (19–63) | 81 (49–169) | 37 (48.1) | — |
| Phase 3 | ||||||
| LTBI | ||||||
| PH | ||||||
| TBTC-29 (22) | 10 mg/kg 5 d per week on empty stomach | 158 (158) | 36 (18–86) | 60 (40–101) | 46 (29.1) | 16 (10.1) |
| Phase 2 | ||||||
| DS-TB | ||||||
| PHZE | ||||||
| RioMar (31) | 7.5 mg/kg once daily with food | 43 (167) | NR | 58 (45–83) | NR | — |
| Phase 2 | ||||||
| DS-TB | ||||||
| PHMZ |
Definition of abbreviations: DS-TB = drug-sensitive tuberculosis disease; HV = healthy volunteers; LTBI = latent tuberculosis infection; Mdz = midazolam, only administered in some of the study participants; NR = not recorded; PH = rifapentine and isoniazid; PHMZ = rifapentine, isoniazid, moxifloxacin, and pyrazinamide; PHZE = rifapentine, isoniazid, pyrazinamide, and ethambutol; PM = rifapentine plus moxifloxacin; Ref = reference number; RIFAQUIN = Rifapentine and a Quinolone in the Treatment of Pulmonary Tuberculosis; RioMar = Rifapentine Plus Moxifloxacin-based Regimen for Treatment of Pulmonary Tuberculosis; TBTC = Tuberculosis Trials Consortium Study.
Data are expressed as median (range) or number (percentage) unless otherwise specified.
A description of each trial is provided, including study phase, population, and drug regimen.