Trial Outcomes & Findings for Assessing PA-824 for Tuberculosis (the APT Trial) (NCT NCT02256696)
NCT ID: NCT02256696
Last Updated: 2023-07-18
Results Overview
The time (days) it takes for the sputum to convert from positive to negative.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
157 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-07-18
Participant Flow
Participant milestones
| Measure |
Arm 1
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
53
|
48
|
|
Overall Study
COMPLETED
|
53
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing PA-824 for Tuberculosis (the APT Trial)
Baseline characteristics by cohort
| Measure |
Arm 1
n=56 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 Participants
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
n=48 Participants
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
30 years
n=7 Participants
|
31 years
n=5 Participants
|
31 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Colored
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Adult (\> 18 years) drug sensitive pulmonary TB patients with weight 40 - 80 kg, HIV Negative or Positive with CD4 \> 350, not on antiretroviral therapy (ART)
The time (days) it takes for the sputum to convert from positive to negative.
Outcome measures
| Measure |
Arm 1
n=53 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=50 Participants
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
n=47 Participants
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Time to Sputum Culture Conversion on Liquid Medium
Time to culture conversion (mITT)
|
42 days
Interval 21.0 to 56.0
|
28 days
Interval 21.0 to 42.0
|
56 days
Interval 42.0 to 70.0
|
|
Time to Sputum Culture Conversion on Liquid Medium
Time to culture conversion (per protocol)
|
42 days
Interval 21.0 to 56.0
|
28 days
Interval 21.0 to 42.0
|
56 days
Interval 42.0 to 70.0
|
PRIMARY outcome
Timeframe: 12 weeksAny Grade 3 event according to the Division of AIDS (DAIDS) toxicity table
Outcome measures
| Measure |
Arm 1
n=56 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 Participants
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
n=48 Participants
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
|
3 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeksIf it is in the best interest of a participant to stop the study regimen for any reason
Outcome measures
| Measure |
Arm 1
n=56 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 Participants
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
n=48 Participants
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Number of Participants With Permanent Discontinuation of Assigned Study Regimen
|
2 Participants
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThe time (days) it takes for the sputum to convert form positive to negative on solid medium
Outcome measures
| Measure |
Arm 1
n=56 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 Participants
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
n=48 Participants
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Time to Culture Conversion on Solid Medium
Time to conversion on solid culture (mITT)
|
28 days
Interval 14.0 to 42.0
|
21 days
Interval 14.0 to 28.0
|
42 days
Interval 21.0 to 56.0
|
|
Time to Culture Conversion on Solid Medium
Time to conversion on solid culture (per protocol)
|
28 days
Interval 14.0 to 42.0
|
21 days
Interval 14.0 to 28.0
|
42 days
Interval 21.0 to 56.0
|
SECONDARY outcome
Timeframe: 8 weeksPercentage of participants whose sputum converts from positive to negative at Week 8 time point, on solid and liquid media.
Outcome measures
| Measure |
Arm 1
n=56 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 Participants
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
n=48 Participants
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Percentage of Participants With Sputum Culture Conversion by 8 Weeks of Treatment
Liquid media
|
79 percentage of participants
|
89 percentage of participants
|
69 percentage of participants
|
|
Percentage of Participants With Sputum Culture Conversion by 8 Weeks of Treatment
Solid media
|
98 percentage of participants
|
100 percentage of participants
|
96 percentage of participants
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 5, 8, and 24 hours post-dose on Day 14Population: This outcome was not assessed in Arm 3, because no participants received PA-824 in Arm 3.
AUC of PA-824 when given with either rifampicin or rifabutin to determine steady state Pharmacokinetics (PK) of PA-824.
Outcome measures
| Measure |
Arm 1
n=56 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 Participants
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Steady State Pharmacokinetics (PK) (AUC) of PA-824 When Given With Rifampin or Rifabutin
|
31.91 mg*h/L
Standard Deviation 9.87
|
59.05 mg*h/L
Standard Deviation 13.30
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 5, 8, and 24 hours post-dose on Day 14Population: This outcome was not assessed in Arm 3, because no participants received PA-824 in Arm 3.
The Pharmacokinetic results (Cmax) of the study drug when given with a rifampin or a rifabutin.
Outcome measures
| Measure |
Arm 1
n=56 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 Participants
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
PK (Cmax) of PA-824 at 200 mg Once Daily With Rifampin or Rifabutin-containing Treatment
|
2.03 mg/L
Standard Deviation 0.51
|
2.69 mg/L
Standard Deviation 0.82
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: This outcome was measured among all participants receiving study drug (PA-824), as one group.
Relationship between PA-824 exposure (AUC) and rate of change in TTP over 12 weeks, using non-linear mixed effects modeling. The data is reported as percentage increase in TTP per 10 unit increase in PA-824 AUC (% increase/10 unit increase PA-824 AUC).
Outcome measures
| Measure |
Arm 1
n=109 Participants
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Relationship Between PA-824 Exposure (AUC) and Rate of Change in Time to Positivity (TTP) Over 12 Weeks
|
9.4 % increase/10 unit increase PA-824 AUC
Interval 4.4 to 15.5
|
—
|
—
|
Adverse Events
Arm 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=56 participants at risk
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 participants at risk
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
n=48 participants at risk
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.8%
1/56 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/48 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic chest pain
|
1.8%
1/56 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/48 • 6 months
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
1/56 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/48 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/56 • 6 months
|
1.9%
1/53 • 6 months
|
0.00%
0/48 • 6 months
|
|
Hepatobiliary disorders
Increased liver enzymes
|
0.00%
0/56 • 6 months
|
5.7%
3/53 • 6 months
|
0.00%
0/48 • 6 months
|
Other adverse events
| Measure |
Arm 1
n=56 participants at risk
PA-824 200 mg once daily (QD),Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 2
n=53 participants at risk
PA-824 200 mg once daily,Rifabutin 300 mg once daily , Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then PA-824 200 mg once daily, Rifabutin 300 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
PA-824: 200 mg QD
Rifabutin: 300 mg QD
Pyrazinamide: 25mg/kg QD
Isoniazid: 300 mg QD
|
Arm 3
n=48 participants at risk
Rifampin 600 mg once daily, Ethambutol 15mg/kg once daily, Isoniazid 5 mg/kg once daily, Pyrazinamide 25 mg/kg once daily x 8 weeks, then Rifampin 600 mg once daily, Isoniazid 5 mg/kg once daily x 4 weeks
Rifampin: 600 mg QD
Pyrazinamide: 25mg/kg QD
Ethambutol: 15mg/kg QD
Isoniazid: 300 mg QD
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Low hemoglobin
|
1.8%
1/56 • 6 months
|
3.8%
2/53 • 6 months
|
2.1%
1/48 • 6 months
|
|
Hepatobiliary disorders
Drug induced liver injury
|
1.8%
1/56 • 6 months
|
1.9%
1/53 • 6 months
|
0.00%
0/48 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/56 • 6 months
|
0.00%
0/53 • 6 months
|
0.00%
0/48 • 6 months
|
|
Cardiac disorders
Increased blood pressure
|
0.00%
0/56 • 6 months
|
0.00%
0/53 • 6 months
|
2.1%
1/48 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place