Trial Outcomes & Findings for TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment (NCT NCT00694629)
NCT ID: NCT00694629
Last Updated: 2026-08-13
Results Overview
Proportion of participants with negative Mycobacterium tuberculosis sputum cultures at completion of the 8-week intensive phase of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
334 participants
Primary outcome timeframe
8 weeks.
Results posted on
2026-08-13
Participant Flow
The Results section reports data from the TBTC Study 29 Extension dose-ranging phase only. Participants included in Participant Flow are those randomized to one of four treatment groups (rifampin, rifapentine 10 mg/kg, rifapentine 15 mg/kg, or rifapentine 20 mg/kg). The Protocol Enrollment value reflects enrollment information for the broader study record and therefore differs from the number of participants included in these reported results.
Participant milestones
| Measure |
Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol
Participants received 8 weeks of daily intensive-phase tuberculosis treatment consisting of rifapentine at the assigned dose in combination with isoniazid, pyrazinamide, and ethambutol.
For control:
Participants received 8 weeks of standard daily intensive-phase tuberculosis treatment with rifampin, isoniazid, pyrazinamide, and ethambutol.
|
lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 10 mg/kg, daily, 8 weeks
|
Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 15 mg/kg, daily, 8 weeks
|
Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: 20 mg/kg, daily, 8 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
87
|
81
|
81
|
|
Overall Study
COMPLETED
|
74
|
82
|
76
|
72
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
5
|
9
|
Reasons for withdrawal
| Measure |
Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol
Participants received 8 weeks of daily intensive-phase tuberculosis treatment consisting of rifapentine at the assigned dose in combination with isoniazid, pyrazinamide, and ethambutol.
For control:
Participants received 8 weeks of standard daily intensive-phase tuberculosis treatment with rifampin, isoniazid, pyrazinamide, and ethambutol.
|
lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 10 mg/kg, daily, 8 weeks
|
Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 15 mg/kg, daily, 8 weeks
|
Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: 20 mg/kg, daily, 8 weeks
|
|---|---|---|---|---|
|
Overall Study
Reason Not Reported.
|
11
|
5
|
5
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol
n=85 Participants
Participants received 8 weeks of daily intensive-phase tuberculosis treatment consisting of rifapentine at the assigned dose in combination with isoniazid, pyrazinamide, and ethambutol.
For control:
Participants received 8 weeks of standard daily intensive-phase tuberculosis treatment with rifampin, isoniazid, pyrazinamide, and ethambutol.
|
lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=87 Participants
rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 10 mg/kg, daily, 8 weeks
|
Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=81 Participants
rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 15 mg/kg, daily, 8 weeks
|
Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=81 Participants
rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: 20 mg/kg, daily, 8 weeks
|
Total
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33 years
n=85 Participants
|
29 years
n=87 Participants
|
31 years
n=81 Participants
|
31 years
n=81 Participants
|
31 years
n=334 Participants
|
|
Sex/Gender, Customized
Male
|
55 participants
n=85 Participants
|
63 participants
n=87 Participants
|
58 participants
n=81 Participants
|
54 participants
n=81 Participants
|
230 participants
n=334 Participants
|
|
Sex/Gender, Customized
Female
|
30 participants
n=85 Participants
|
24 participants
n=87 Participants
|
23 participants
n=81 Participants
|
27 participants
n=81 Participants
|
104 participants
n=334 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
HIV status
HIV positive
|
5 Participants
n=85 Participants
|
6 Participants
n=87 Participants
|
4 Participants
n=81 Participants
|
11 Participants
n=81 Participants
|
26 Participants
n=334 Participants
|
|
HIV status
HIV negative
|
80 Participants
n=85 Participants
|
81 Participants
n=87 Participants
|
77 Participants
n=81 Participants
|
70 Participants
n=81 Participants
|
308 Participants
n=334 Participants
|
PRIMARY outcome
Timeframe: 8 weeks.Population: Participants with evaluable sputum culture results at 8 weeks.
Proportion of participants with negative Mycobacterium tuberculosis sputum cultures at completion of the 8-week intensive phase of treatment.
Outcome measures
| Measure |
Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol
n=64 Participants
Participants received 8 weeks of daily intensive-phase tuberculosis treatment consisting of rifapentine at the assigned dose in combination with isoniazid, pyrazinamide, and ethambutol.
For control:
Participants received 8 weeks of standard daily intensive-phase tuberculosis treatment with rifampin, isoniazid, pyrazinamide, and ethambutol.
|
lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=62 Participants
rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 10 mg/kg, daily, 8 weeks
|
Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=66 Participants
rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 15 mg/kg, daily, 8 weeks
|
Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=57 Participants
rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: 20 mg/kg, daily, 8 weeks
|
|---|---|---|---|---|
|
Participants With Negative Sputum Culture at 8 Weeks
|
52 participants
|
62 participants
|
59 participants
|
54 participants
|
PRIMARY outcome
Timeframe: 8 weeksNumber of participants who permanently discontinued assigned study treatment for any reason during the first 8 weeks.
Outcome measures
| Measure |
Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol
n=85 Participants
Participants received 8 weeks of daily intensive-phase tuberculosis treatment consisting of rifapentine at the assigned dose in combination with isoniazid, pyrazinamide, and ethambutol.
For control:
Participants received 8 weeks of standard daily intensive-phase tuberculosis treatment with rifampin, isoniazid, pyrazinamide, and ethambutol.
|
lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=87 Participants
rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 10 mg/kg, daily, 8 weeks
|
Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=81 Participants
rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: tablet, 15 mg/kg, daily, 8 weeks
|
Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
n=81 Participants
rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol
rifapentine: 20 mg/kg, daily, 8 weeks
|
|---|---|---|---|---|
|
Participants Who Discontinued Treatment During Intensive Phase
|
11 participants
|
5 participants
|
5 participants
|
9 participants
|
Adverse Events
Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place