Trial Outcomes & Findings for Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT (NCT NCT01582711)
NCT ID: NCT01582711
Last Updated: 2025-03-13
Results Overview
To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1002 participants
Primary outcome timeframe
Up to 16 weeks from start of treatment.
Results posted on
2025-03-13
Participant Flow
Participant milestones
| Measure |
3HP Directly Observed Therapy (DOT)
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
|
3HP Self Administered Therapy (SAT)
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
|
3HP SAT With SMS Reminders
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
|
|---|---|---|---|
|
Overall Study
STARTED
|
337
|
337
|
328
|
|
Overall Study
COMPLETED
|
337
|
337
|
328
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
Baseline characteristics by cohort
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
n=328 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
Total
n=1002 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
36 years
n=7 Participants
|
38 years
n=5 Participants
|
36 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
482 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
520 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
68 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
84 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
518 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
261 participants
n=5 Participants
|
262 participants
n=7 Participants
|
251 participants
n=5 Participants
|
774 participants
n=4 Participants
|
|
Region of Enrollment
China
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
28 participants
n=5 Participants
|
83 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
35 participants
n=5 Participants
|
32 participants
n=7 Participants
|
33 participants
n=5 Participants
|
100 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeks from start of treatment.Population: Participants analyzed excludes 4 participants (2 in each SAT groups) who were enrolled as contacts of a person with active TB before susceptibility results had returned showing resistance to isoniazid or rifampin in source patient. These participants were excluded from treatment completion analyses.
To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.
Outcome measures
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=335 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
n=326 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
|---|---|---|---|
|
Treatment Completion Rate.
|
294 Participants
|
248 Participants
|
250 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeks from start of treatment.Population: Participants analyzed excludes 4 participants (2 in each SAT groups) who were enrolled as contacts of a person with active TB before susceptibility results had returned showing resistance to isoniazid or rifampin in source patient. These participants were excluded from treatment completion analyses.
To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders
Outcome measures
| Measure |
3HP Directly Observed Therapy (DOT)
n=335 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=326 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
|---|---|---|---|
|
Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders
|
248 Participants
|
250 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 16 weeks from start of treatment.The number and proportion of participants who adhered (completed treatment) based on pill count and self-report, considered to be standard of care (SOC) vs. the number of participants who completed treatment based on SOC plus MEMS cap.
Outcome measures
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
n=328 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
|---|---|---|---|
|
The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS
Treatment completion proportion based on pill count/self-report
|
294 Participants
|
271 Participants
|
266 Participants
|
|
The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS
Treatment completion proportion based on pill count/self-report and MEMS cap
|
294 Participants
|
248 Participants
|
249 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeks from start of treatment.Population: 'Proportion of Participants willing to use SMS (Acceptability) (eSAT arm ONLY)' analysis was only done in '3HP SAT with SMS Reminders'.
To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study.
Outcome measures
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=328 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
|---|---|---|---|
|
Availability and Acceptability
Proportion of Participants have cell SMS phone (Availability)
|
34 Participants
|
29 Participants
|
28 Participants
|
|
Availability and Acceptability
Proportion of Participants willing to use SMS (Acceptability) (eSAT arm ONLY)
|
0 Participants
|
229 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeks from start of treatment.To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually)
Outcome measures
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
n=328 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
|---|---|---|---|
|
Number and Percentage of Participants With Drug-related Grade 3 or 4 Adverse Events or Death
|
23 Participants
|
23 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to 16 weeks from start of treatment.To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms (both combined and individually) including discontinuation due to: * non-adherence * any adverse event (AE) * a diagnosis of active TB * other reasons
Outcome measures
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
n=328 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
|---|---|---|---|
|
Number and Percentage of Participants Reason for Failure to Complete Treatment
Study therapy not started
|
3 Participants
|
7 Participants
|
4 Participants
|
|
Number and Percentage of Participants Reason for Failure to Complete Treatment
Drug toxicities causing permanent discontinuation
|
12 Participants
|
18 Participants
|
14 Participants
|
|
Number and Percentage of Participants Reason for Failure to Complete Treatment
Failure to complete minimum number of PP doses
|
4 Participants
|
7 Participants
|
9 Participants
|
|
Number and Percentage of Participants Reason for Failure to Complete Treatment
Not advisable to continue study drugs
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number and Percentage of Participants Reason for Failure to Complete Treatment
Refused further study therapy
|
6 Participants
|
7 Participants
|
11 Participants
|
|
Number and Percentage of Participants Reason for Failure to Complete Treatment
Patient became pregnant
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number and Percentage of Participants Reason for Failure to Complete Treatment
Other
|
9 Participants
|
12 Participants
|
11 Participants
|
|
Number and Percentage of Participants Reason for Failure to Complete Treatment
Unknown/Missing
|
2 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 20 weeks from start of treatment.Population: This analysis was conducted in 81 (DOT-40, SAT-41) participants from 7 study sites. As pre-specified in the protocol, DOT cost maybe prohibitive to TB programs, and SAT cost may provide a cost-effective alternative. Data was collected and analyzed to assess DOT costs vs SAT costs, such that the distinction between SAT and eSAT arms were not appropriate. As a result, participants in the SAT arms were combined to find total cost.
To collect patient-specific cost data related to the DOT and SAT arms
Outcome measures
| Measure |
3HP Directly Observed Therapy (DOT)
n=40 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=41 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
|---|---|---|---|
|
Patient-specific Cost
|
361.50 U.S. Dollar
Interval 125.0 to 425.0
|
257.82 U.S. Dollar
Interval 90.0 to 340.0
|
—
|
SECONDARY outcome
Timeframe: Up to 16 weeks from start of treatment.Population: Participants analyzed excludes 4 participants (2 in each SAT groups) who were enrolled as contacts of a person with active TB before susceptibility results had returned showing resistance to isoniazid or rifampin in source patient. These participants were excluded from drug resistance analyses.
To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.
Outcome measures
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP Self Administered Therapy (SAT)
n=335 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
3HP SAT With SMS Reminders
n=326 Participants
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Self Administered Therapy (SAT): Self Administered Therapy (SAT)
SMS reminders: Short Message Service (SMS) text reminders
isoniazid and rifapentine: rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
|
|---|---|---|---|
|
Antituberculosis Drug Resistance
Developed TB but not drug resistant
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Antituberculosis Drug Resistance
Antituberculosis Drug Resistant
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
3HP Directly Observed Therapy (DOT)
Serious events: 11 serious events
Other events: 42 other events
Deaths: 0 deaths
3HP Self Administered Therapy (SAT)
Serious events: 5 serious events
Other events: 54 other events
Deaths: 0 deaths
3HP SAT With SMS Reminders
Serious events: 6 serious events
Other events: 56 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 participants at risk
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
|
3HP Self Administered Therapy (SAT)
n=337 participants at risk
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
|
3HP SAT With SMS Reminders
n=328 participants at risk
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
|
|---|---|---|---|
|
Gastrointestinal disorders
Acute gastroenteritis
|
0.30%
1/337 • Number of events 1 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/337 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.30%
1/328 • Number of events 1 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
|
General disorders
Systemic Drug Reaction
|
0.30%
1/337 • Number of events 1 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/337 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/328 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
|
General disorders
rheumatoid arthritis flare
|
0.30%
1/337 • Number of events 1 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/337 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/328 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
|
General disorders
fatigue
|
0.00%
0/337 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/337 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.30%
1/328 • Number of events 1 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
|
General disorders
unrelated to study drug
|
2.4%
8/337 • Number of events 8 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
1.5%
5/337 • Number of events 5 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
1.2%
4/328 • Number of events 4 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
Other adverse events
| Measure |
3HP Directly Observed Therapy (DOT)
n=337 participants at risk
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
|
3HP Self Administered Therapy (SAT)
n=337 participants at risk
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
|
3HP SAT With SMS Reminders
n=328 participants at risk
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
|
|---|---|---|---|
|
General disorders
Systemic Drug Reaction
|
3.9%
13/337 • Number of events 13 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
4.5%
15/337 • Number of events 15 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
4.3%
14/328 • Number of events 14 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
|
General disorders
Hepatitis
|
0.30%
1/337 • Number of events 1 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.89%
3/337 • Number of events 3 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
1.5%
5/328 • Number of events 5 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
|
General disorders
Thrombocytopenia
|
0.00%
0/337 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/337 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.30%
1/328 • Number of events 1 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
|
General disorders
Neutropenia
|
0.30%
1/337 • Number of events 1 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/337 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
0.00%
0/328 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
|
General disorders
Other
|
8.0%
27/337 • Number of events 27 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
10.7%
36/337 • Number of events 36 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
15.2%
50/328 • Number of events 50 • Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place