Trial Outcomes & Findings for Essentiality of INH in TB Therapy (NCT NCT01589497)
NCT ID: NCT01589497
Last Updated: 2018-04-06
Results Overview
The daily decrease was calculated as follows: EBA0-14(CFU)= \[baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) - log10 CFU/mL at day 14\]/14. For a CFU/ml count of 0, the log10 CFU/mL was set to 0. No formal statistical testing was conducted to compare the arms. Please refer to the explanation in the Protocol Section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Pre-entry, Day 0 and Day 14
Results posted on
2018-04-06
Participant Flow
Recruited at two AIDS Clinical Trials Units in South Africa. Recruitment occurred between June 30, 2015 (date of first participant was randomized) and January 13, 2016 (date of last participant was randomized).
69 were randomized 1:1:1:1 to 4 treatment arms. Among the 69 participants, 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Participant milestones
| Measure |
RHZE-RHZE
Participants were administered RHZE from Day 1 to Day 14. Rifampicin: Participants with body weight \</= 50kg were administered one 450 mg tablet orally once daily; with body weight \>50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Rifampicin: Participants with body weight \</= 50kg were administered one 450 mg tablet orally once daily; with body weight \>50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Rifampicin: Participants with body weight \</= 50kg were administered one 450 mg tablet orally once daily; with body weight \>50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.
Moxifloxacin: one 400 mg tablet orally once a day.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14. Rifampicin: Participants with body weight \</= 50kg were administered one 450 mg tablet orally once daily; with body weight \>50kg were administered one 600 mg tablet orally once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
16
|
18
|
|
Overall Study
COMPLETED
|
17
|
16
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
RHZE-RHZE
Participants were administered RHZE from Day 1 to Day 14. Rifampicin: Participants with body weight \</= 50kg were administered one 450 mg tablet orally once daily; with body weight \>50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Rifampicin: Participants with body weight \</= 50kg were administered one 450 mg tablet orally once daily; with body weight \>50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Rifampicin: Participants with body weight \</= 50kg were administered one 450 mg tablet orally once daily; with body weight \>50kg were administered one 600 mg tablet orally once daily.
Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.
Moxifloxacin: one 400 mg tablet orally once a day.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14. Rifampicin: Participants with body weight \</= 50kg were administered one 450 mg tablet orally once daily; with body weight \>50kg were administered one 600 mg tablet orally once daily.
Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Pre-entry overnight sputum< 10ML
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Essentiality of INH in TB Therapy
Baseline characteristics by cohort
| Measure |
RHZE-RHZE
n=18 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=17 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=16 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=18 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.5 years
n=5 Participants
|
31 years
n=7 Participants
|
33.5 years
n=5 Participants
|
32 years
n=4 Participants
|
31 years
n=21 Participants
|
|
Age, Customized
<20
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Customized
20-29
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Customized
30-39
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Customized
40-49
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Customized
50-59
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Karnofsky score
|
90 scores on a scale
n=5 Participants
|
90 scores on a scale
n=7 Participants
|
90 scores on a scale
n=5 Participants
|
90 scores on a scale
n=4 Participants
|
90 scores on a scale
n=21 Participants
|
|
BMI
|
18.5 kg/m^2
n=5 Participants
|
19.4 kg/m^2
n=7 Participants
|
19.8 kg/m^2
n=5 Participants
|
18.7 kg/m^2
n=4 Participants
|
18.9 kg/m^2
n=21 Participants
|
|
HIV status
HIV negative
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
18 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
HIV status
HIV positive
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-entry, Day 0 and Day 14Population: Participants with qualified sputum samples who had results available at all time points specified in the time-frame
The daily decrease was calculated as follows: EBA0-14(CFU)= \[baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) - log10 CFU/mL at day 14\]/14. For a CFU/ml count of 0, the log10 CFU/mL was set to 0. No formal statistical testing was conducted to compare the arms. Please refer to the explanation in the Protocol Section.
Outcome measures
| Measure |
RHZE-RHZE
n=12 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=11 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=10 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=15 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Daily Decrease in log10 Transformed Colony-forming Unit (CFU) Counts Per ml Sputum From Baseline (Study Treatment Initiation) to Day 14
|
0.134 log10 CFU/ mL
Interval 0.078 to 0.167
|
0.096 log10 CFU/ mL
Interval 0.028 to 0.211
|
0.136 log10 CFU/ mL
Interval 0.09 to 0.169
|
0.119 log10 CFU/ mL
Interval 0.05 to 0.173
|
SECONDARY outcome
Timeframe: Pre-entry, Day 0 and Day 14Population: Participants with qualified sputum samples who had results available at all time points specified in the time-frame
The daily change in TTP was calculated as follows: EBA0-14(TTP) = \[baseline TTP (mean of TTP at pre-entry and day 0) - TTP at day 14\]/14.
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=16 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 14
|
-12 hours
Interval -17.0 to -9.0
|
-12 hours
Interval -16.0 to -8.0
|
-13 hours
Interval -17.0 to -10.0
|
-11 hours
Interval -14.0 to -9.0
|
SECONDARY outcome
Timeframe: Pre-entry, Day 0 and Day 2Population: Participants with qualified sputum samples who had results available at all time points specified in the time-frame
The daily change in log10 CFU/mL sputum was calculated as follows: EBA0-2(CFU) = (baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) - log10 CFU/mL at day 2)/2. For a CFU/mL count of 0, the log10 CFU/mL was set to 0.
Outcome measures
| Measure |
RHZE-RHZE
n=12 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=13 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=12 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=12 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Daily Change in log10 Transformed Colony-forming Unit (CFU) Counts Per mL Sputum From Baseline (Study Treatment Initiation) to Day 2
|
0.255 log10 CFU/ mL
Interval -0.037 to 0.519
|
0.385 log10 CFU/ mL
Interval -0.05 to 0.475
|
0.111 log10 CFU/ mL
Interval 0.001 to 0.409
|
0.034 log10 CFU/ mL
Interval -0.366 to 0.443
|
SECONDARY outcome
Timeframe: Day 2 and day 14Population: Participants with qualified sputum samples who had results available at all time points specified in the time-frame
The daily change in log10 CFU/mL sputum was calculated as follows: EBA2-14(CFU) = (log10 CFU/mL at day 2 - log10 CFU/mL at day 14)/12. For a CFU/mL count of 0, the log10 CFU/mL was set to 0.
Outcome measures
| Measure |
RHZE-RHZE
n=10 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=11 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=11 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=11 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Daily Change in log10 Colony-forming Unit (CFU) Counts Per mL Sputum From Day 2 to Day 14
|
0.143 log10 CFU/ mL
Interval 0.104 to 0.203
|
0.093 log10 CFU/ mL
Interval 0.01 to 0.171
|
0.123 log10 CFU/ mL
Interval 0.113 to 0.173
|
0.104 log10 CFU/ mL
Interval 0.065 to 0.277
|
SECONDARY outcome
Timeframe: Pre-entry, Day 0 and Day 2Population: Participants with qualified sputum samples who had results available at all time points specified in the time-frame
The daily change in TTP was calculated as follows: EBA0-2(TTP) = (baseline TTP (mean of TTP at pre-entry and day 0) - TTP at day 2)/2.
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=16 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 2
|
-31 hours
Interval -44.0 to -22.0
|
-30 hours
Interval -44.0 to -15.0
|
-29 hours
Interval -35.0 to -18.0
|
-25 hours
Interval -28.0 to -18.0
|
SECONDARY outcome
Timeframe: Day 2 and Day 14Population: Participants with qualified sputum samples who had results available at all time points specified in the time-frame
The daily change in TTP was calculated as follows: EBA2-14(TTP) = (TTP at day 2 - TTP at day 14)/12.
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Daily Change in Time to Positivity (TTP) From Day 2 to Day 14
|
-9 hours
Interval -12.0 to -6.0
|
-9 hours
Interval -13.0 to -6.0
|
-12 hours
Interval -14.0 to -8.0
|
-9 hours
Interval -12.0 to -7.0
|
SECONDARY outcome
Timeframe: Pre-entry, Day 0 and Day 14Population: Participants with qualified sputum samples who had results available at least one time point specified in the time-frame
The log10 CFU count per mL from sputum samples processed by standard method or decontaminated method.
Outcome measures
| Measure |
RHZE-RHZE
n=63 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=63 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Log10 Transformed Colony-forming Unit (CFU) Count Per mL From Sputum Samples at Baseline and Day 14
Pre-entry
|
5.80 log10 CFU/ mL
Interval 5.16 to 6.76
|
5.89 log10 CFU/ mL
Interval 5.1 to 6.62
|
—
|
—
|
|
Log10 Transformed Colony-forming Unit (CFU) Count Per mL From Sputum Samples at Baseline and Day 14
Day 0
|
5.68 log10 CFU/ mL
Interval 5.16 to 6.65
|
5.58 log10 CFU/ mL
Interval 5.02 to 6.41
|
—
|
—
|
|
Log10 Transformed Colony-forming Unit (CFU) Count Per mL From Sputum Samples at Baseline and Day 14
Day 14
|
4.01 log10 CFU/ mL
Interval 3.34 to 4.6
|
3.74 log10 CFU/ mL
Interval 3.11 to 4.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-entry, Day 0, Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11 and Day 14Population: Participants with qualified sputum samples who had results available at least one time point specified in the time-frame
Pearson correlation coefficient was used to examine the correlation between TTP and log10 CFU among all qualified samples obtained on study
Outcome measures
| Measure |
RHZE-RHZE
n=63 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Correlation Between Time to Positivity (TTP) and log10 Transformed Colony-forming Unit (CFU) Counts Per mL
|
-0.75 correlation coefficient
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis
Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUCs) of Rifampicin from 0 to 24 hours obtained at Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-24hour) for Rifampicin (RIF)
RIF AUC0-24hour at Day 1
|
37358.8 h*ng/mL
Interval 23946.7 to 70314.2
|
42062.6 h*ng/mL
Interval 23048.7 to 77672.3
|
51434.1 h*ng/mL
Interval 42018.3 to 69759.7
|
39294.0 h*ng/mL
Interval 21282.6 to 55823.8
|
|
Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-24hour) for Rifampicin (RIF)
RIF AUC0-24hour at Day 14
|
31361.4 h*ng/mL
Interval 15709.9 to 42480.9
|
27161.7 h*ng/mL
Interval 14436.6 to 31522.2
|
26751.2 h*ng/mL
Interval 16603.9 to 32635.8
|
30521.0 h*ng/mL
Interval 20749.5 to 35307.8
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis
Rifampicin PK parameter Clearance (CL/F) obtained Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Rifampicin PK Parameter Clearance (CL/F)
RIF CL/F Day 1
|
14.0 L/hour
Interval 8.3 to 20.1
|
12.5 L/hour
Interval 7.7 to 26.0
|
10.5 L/hour
Interval 7.2 to 14.3
|
14.3 L/hour
Interval 9.2 to 21.1
|
|
Rifampicin PK Parameter Clearance (CL/F)
RIF CL/F Day 14
|
18.0 L/hour
Interval 14.1 to 34.0
|
22.1 L/hour
Interval 14.3 to 31.2
|
21.5 L/hour
Interval 15.7 to 36.1
|
17.0 L/hour
Interval 14.7 to 22.0
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis
Rifampicin PK parameter Parameter Maximum Plasma Concentration (Cmax) obtained Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Rifampicin PK Parameter Maximum Plasma Concentration (Cmax)
RIF Cmax at Day 1
|
5565 ng/mL
Interval 3600.0 to 7685.0
|
6060 ng/mL
Interval 3200.0 to 9550.0
|
8660 ng/mL
Interval 4520.0 to 10800.0
|
4880 ng/mL
Interval 3370.0 to 7740.0
|
|
Rifampicin PK Parameter Maximum Plasma Concentration (Cmax)
RIF Cmax at Day 14
|
7145 ng/mL
Interval 3525.0 to 9055.0
|
6960 ng/mL
Interval 3930.0 to 9020.0
|
7370 ng/mL
Interval 4700.0 to 9580.0
|
8350 ng/mL
Interval 5390.0 to 8970.0
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis
Rifampicin (RIF) PK parameter Last Concentration (CLast) obtained Day 1 and Day 14. The lower limit of quantification of the assay (LLOQ) for RIF was 40 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 20 ng/mL.
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Rifampicin PK Parameter Last Concentration (CLast)
RIF CLast at Day 1
|
74.5 ng/mL
Interval 20.0 to 232.0
|
20 ng/mL
Interval 20.0 to 229.0
|
133 ng/mL
Interval 20.0 to 288.0
|
20 ng/mL
Interval 20.0 to 272.0
|
|
Rifampicin PK Parameter Last Concentration (CLast)
RIF CLast at Day 14
|
20 ng/mL
Interval 20.0 to 20.0
|
20 ng/mL
Interval 20.0 to 20.0
|
20 ng/mL
Interval 20.0 to 20.0
|
20 ng/mL
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.
PK AUCs of Isoniazid (INH) from 0 to 24 hours obtained at Day 1
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
AUC0-24hour for Isoniazid (INH) at Day 1
|
10725.8 h*ng/mL
Interval 6412.9 to 16492.5
|
7970.6 h*ng/mL
Interval 4594.4 to 16101.7
|
7165.1 h*ng/mL
Interval 4974.5 to 19045.0
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.
Isoniazid PK parameter CL/F obtained Day 1
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Isoniazid PK Parameter CL/F at Day 1
|
28.0 L/hour
Interval 18.3 to 49.6
|
37.6 L/hour
Interval 18.6 to 65.3
|
41.9 L/hour
Interval 21.0 to 60.6
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.
Isoniazid PK parameter Cmax obtained Day 1
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Isoniazid PK Parameter Cmax at Day 1
|
3165 ng/mL
Interval 2315.0 to 4060.0
|
2920 ng/mL
Interval 1530.0 to 3610.0
|
2760 ng/mL
Interval 1760.0 to 4030.0
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.
Isoniazid (INH) PK parameter CLast obtained Day 1. The lower limit of quantification of the assay (LLOQ) for INH was 100 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 50 ng/mL.
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Isoniazid PK Parameter CLast at Day 1
|
50 ng/mL
Interval 50.0 to 50.0
|
50 ng/mL
Interval 50.0 to 50.0
|
50 ng/mL
Interval 50.0 to 50.0
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.
PK AUCs of Isoniazid from 0 to 24 hours obtained at Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
AUC0-24hour for Isoniazid at Day 14
|
9797.2 h*ng/mL
Interval 6931.1 to 16355.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.
Isoniazid PK parameter CL/F obtained Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Isoniazid PK Parameter CL/F at Day 14
|
30.6 L/hour
Interval 18.4 to 46.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.
Isoniazid PK parameter Cmax obtained Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Isoniazid PK Parameter Cmax at Day 14
|
3130 ng/mL
Interval 2485.0 to 3920.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.
Isoniazid (INH) PK parameter CLast obtained Day 14. The lower limit of quantification of the assay (LLOQ) for INH was 100 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 50 ng/mL.
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Isoniazid PK Parameter CLast at Day 14
|
50 ng/mL
Interval 50.0 to 50.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
PK AUCs of Pyrazinamide (PZA) from 0 to 24 hours obtained at Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
AUC0-24hour for Pyrazinamide (PZA)
PZA AUC0-24hour at Day 1
|
301214.5 h*ng/mL
Interval 243041.4 to 344110.0
|
255283.0 h*ng/mL
Interval 204379.9 to 349309.1
|
292078.2 h*ng/mL
Interval 249250.9 to 304794.0
|
272853.9 h*ng/mL
Interval 217158.6 to 314465.1
|
|
AUC0-24hour for Pyrazinamide (PZA)
PZA AUC0-24hour at Day 14
|
249879.1 h*ng/mL
Interval 202652.1 to 319071.7
|
201389.7 h*ng/mL
Interval 174896.2 to 280573.1
|
280071.0 h*ng/mL
Interval 221878.7 to 312248.4
|
252276.8 h*ng/mL
Interval 192061.9 to 307469.4
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Pyrazinamide PK parameter CL/F obtained Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Pyrazinamide PK Parameter CL/F
PZA CL/F Day 1
|
4.1 L/hour
Interval 3.3 to 5.0
|
4.8 L/hour
Interval 3.9 to 5.8
|
4.7 L/hour
Interval 3.4 to 5.2
|
4.2 L/hour
Interval 3.7 to 4.9
|
|
Pyrazinamide PK Parameter CL/F
PZA CL/F Day 14
|
4.5 L/hour
Interval 4.0 to 6.5
|
5.4 L/hour
Interval 4.8 to 6.9
|
4.7 L/hour
Interval 3.9 to 5.3
|
4.7 L/hour
Interval 3.8 to 5.8
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Pyrazinamide PK parameter Cmax obtained Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Pyrazinamide PK Parameter Cmax
PZA Cmax at Day 1
|
27650 ng/mL
Interval 24400.0 to 36550.0
|
27000 ng/mL
Interval 20800.0 to 29100.0
|
28800 ng/mL
Interval 23900.0 to 32600.0
|
25800 ng/mL
Interval 24100.0 to 29000.0
|
|
Pyrazinamide PK Parameter Cmax
PZA Cmax at Day 14
|
29300 ng/mL
Interval 24950.0 to 34350.0
|
27000 ng/mL
Interval 22900.0 to 31000.0
|
29300 ng/mL
Interval 25500.0 to 33900.0
|
28000 ng/mL
Interval 26300.0 to 31900.0
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Pyrazinamide PK parameter CLast obtained Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Pyrazinamide PK Parameter CLast
PZA CLast at Day 1
|
3370 ng/mL
Interval 2320.0 to 5470.0
|
2850 ng/mL
Interval 1500.0 to 5050.0
|
3130 ng/mL
Interval 2570.0 to 3460.0
|
2710 ng/mL
Interval 1930.0 to 3830.0
|
|
Pyrazinamide PK Parameter CLast
PZA CLast at Day 14
|
1955.0 ng/mL
Interval 997.5 to 2735.0
|
1280 ng/mL
Interval 909.0 to 3050.0
|
1790 ng/mL
Interval 1450.0 to 2900.0
|
1770 ng/mL
Interval 1270.0 to 2150.0
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
PK AUCs of Ethambutol (EMB) from 0 to 24 hours obtained at Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
AUC0-24hour for Ethambutol (EMB)
EMB AUC0-24hour at Day 1
|
11918.8 h*ng/mL
Interval 9783.4 to 12803.2
|
11145.8 h*ng/mL
Interval 9336.6 to 14125.3
|
11322.4 h*ng/mL
Interval 9549.6 to 13937.0
|
10716.8 h*ng/mL
Interval 9381.2 to 13678.0
|
|
AUC0-24hour for Ethambutol (EMB)
EMB AUC0-24hour at Day 14
|
16414.9 h*ng/mL
Interval 13813.1 to 19637.1
|
16675.9 h*ng/mL
Interval 12589.8 to 18585.1
|
15181.2 h*ng/mL
Interval 14074.7 to 17338.1
|
16574.6 h*ng/mL
Interval 13314.9 to 17422.2
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Ethambutol PK parameter CL/F obtained Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Ethambutol PK Parameter CL/F
EMB CL/F Day 1
|
93.6 L/hour
Interval 68.7 to 105.0
|
85.4 L/hour
Interval 73.9 to 97.1
|
83.8 L/hour
Interval 65.4 to 106.0
|
76.5 L/hour
Interval 73.9 to 89.8
|
|
Ethambutol PK Parameter CL/F
EMB CL/F Day 14
|
57.9 L/hour
Interval 51.0 to 65.9
|
63.5 L/hour
Interval 53.5 to 72.0
|
56.8 L/hour
Interval 47.1 to 75.2
|
60.1 L/hour
Interval 52.4 to 64.4
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Ethambutol PK parameter Cmax obtained Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Ethambutol PK Parameter Cmax
EMB Cmax at Day 1
|
2650 ng/mL
Interval 1745.0 to 2960.0
|
2040 ng/mL
Interval 1840.0 to 2460.0
|
2470 ng/mL
Interval 1790.0 to 3460.0
|
2220 ng/mL
Interval 1900.0 to 2680.0
|
|
Ethambutol PK Parameter Cmax
EMB Cmax at Day 14
|
2980 ng/mL
Interval 2220.0 to 3525.0
|
3090 ng/mL
Interval 2270.0 to 3370.0
|
2780 ng/mL
Interval 2580.0 to 3220.0
|
2920 ng/mL
Interval 2530.0 to 3250.0
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Ethambutol PK parameter CLast obtained Day 1 and Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=16 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=15 Participants
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=17 Participants
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Ethambutol PK Parameter CLast
EMB CLast at Day 1
|
86.5 ng/mL
Interval 40.0 to 106.5
|
85 ng/mL
Interval 40.0 to 107.0
|
40 ng/mL
Interval 40.0 to 94.0
|
86 ng/mL
Interval 40.0 to 95.0
|
|
Ethambutol PK Parameter CLast
EMB CLast at Day 14
|
205.0 ng/mL
Interval 167.0 to 235.5
|
176 ng/mL
Interval 159.0 to 208.0
|
164 ng/mL
Interval 136.0 to 199.0
|
159 ng/mL
Interval 134.0 to 204.0
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14
PK AUCs of Moxiflozacin (Mox) from 0 to 24 hours obtained at Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
AUC0-24hour for Moxifloxacin (Mox) at Day 14
|
22498.4 h*ng/mL
Interval 21012.8 to 23318.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14
Moxifloxacin PK parameter CL/F obtained Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Moxifloxacin PK Parameter CL/F at Day 14
|
17.8 L/hour
Interval 17.2 to 19.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14
Moxifloxacin PK parameter Cmax obtained Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Moxifloxacin PK Parameter Cmax at Day 14
|
3010 ng/mL
Interval 2710.0 to 3500.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14Population: 63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14.
Moxifloxacin PK parameter CLast obtained Day 14
Outcome measures
| Measure |
RHZE-RHZE
n=15 Participants
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Moxifloxacin PK Parameter CLast at Day 14
|
178 ng/mL
Interval 150.0 to 217.0
|
—
|
—
|
—
|
Adverse Events
RHZE-RHZE
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
RHZE-RZE
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
RHZE-RMZE
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
RZE-RZE
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RHZE-RHZE
n=18 participants at risk
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=17 participants at risk
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=16 participants at risk
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=18 participants at risk
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
6.2%
1/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Nervous system disorders
Loss of consciousness
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.9%
1/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
6.2%
1/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
Other adverse events
| Measure |
RHZE-RHZE
n=18 participants at risk
Participants were administered RHZE from Day 1 to Day 14.
|
RHZE-RZE
n=17 participants at risk
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
|
RHZE-RMZE
n=16 participants at risk
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
|
RZE-RZE
n=18 participants at risk
Participants were administered only RZE from Day 1 through Day 14.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.9%
1/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
6.2%
1/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Gastrointestinal disorders
Toothache
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.9%
1/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
General disorders
Chest pain
|
11.1%
2/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
11.1%
2/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
2/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
2/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.9%
1/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
11.8%
2/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
12.5%
2/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
6.2%
1/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
11.1%
2/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
6.2%
1/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.9%
1/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
6.2%
1/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.6%
1/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/17 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/16 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
0.00%
0/18 • From treatment dispensation to study discontinuation. The duration of the study was 29 days.
The protocol required reporting of all new diagnoses and new signs and symptoms and laboratory abnormalities of \>=Grade 2. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social & Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER