At a glance
ClinicalIndex Comparison Record- ✓Age >2 years, males or non-pregnant non-nursing females
- ✓TST-positive high-risk reactors including household/close contacts of culture-confirmed TB cases (TST >5 mm)
- ✓TST converters: negative to positive within 2 years, or increase of >10 mm within 2 years
- ✓HIV-seropositive with TST >5 mm induration
- ✕Current confirmed culture-positive or clinical tuberculosis
- ✕Suspected TB as defined by site investigator
- ✕TB resistant to isoniazid or rifampin in the source case
- ✕Prior rifamycin treatment >14 consecutive days or INH >30 consecutive days in previous 2 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TBTC Study 26: Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months Versus Daily Isoniazid for 9 Months for the Treatment of Latent Tuberculosis Infection
In Brief
A Phase 3 clinical trial evaluating RPT + INH once weekly for 3 months given by DOT and Isoniazid (INH) daily for 9 months for Tuberculosis. Completed, enrolled 8,053 participants across 26 sites in 4 countries.
Detailed Summary
Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).
Study Details
Timeline
Interventions
Rifapentine (RPT) 900 mg once-weekly x 12 doses (3 months) for persons \> 50.0 kg. For persons \< 50.0 kg, the following doses will be given (Weight/Dose): 10.0-14.0 kg / 300 mg; 14.1-25.0 kg / 450 mg; 25.1-32.0 kg / 600 mg; 32.1-50.0 kg / 750 mg. PLUS Isoniazid (INH) 15 mg/kg (rounded up to nearest 50 or 100 mg; 900 mg max) once weekly x 12 doses if \> 12 years old. INH 25 mg/kg (round up to nearest 50 or 100 mg; 900 mg max) if 2-11 years old. Therapy will be given by Directly Observed Therapy (DOT).
Isoniazid (INH) 5 mg/kg (rounded up to nearest 50 or 100 mg; 300 mg max) daily x 270 doses (9 months) For children age 2 - 11, INH 10-15 mg/kg (round up to nearest 50 or 100 mg; 300 mg max) will be given.