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Essentiality of INH in TB Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01589497
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : April 4, 2017
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tuberculosis
Interventions Drug: Rifampicin
Drug: Isoniazid
Drug: Pyrazinamide
Drug: Ethambutol
Drug: Moxifloxacin
Enrollment 69
Recruitment Details 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).
Pre-assignment Details 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.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description

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.

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

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.

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.
Period Title: Overall Study
Started 18 17 16 18
Completed 17 [1] 16 [1] 15 17
Not Completed 1 1 1 1
Reason Not Completed
Withdrawal by Subject             0             1             0             1
Death             1             0             0             0
Pre-entry overnight sputum< 10ML             0             0             1             0
[1]
1 participant who completed study but had insufficient sputum volume was excluded from the analyses
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE Total
Hide Arm/Group Description Participants were administered RHZE from Day 1 to Day 14. Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14. Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14. Participants were administered only RZE from Day 1 through Day 14. Total of all reporting groups
Overall Number of Baseline Participants 18 17 16 18 69
Hide Baseline Analysis Population Description
Intent to treat: All enrolled 69 participants were included in the baseline characteristics.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 16 participants 18 participants 69 participants
28.5
(22 to 33)
31
(30 to 35)
33.5
(25.5 to 43)
32
(21 to 44)
31
(24 to 40)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 16 participants 18 participants 69 participants
<20
2
  11.1%
0
   0.0%
1
   6.3%
1
   5.6%
4
   5.8%
20-29
7
  38.9%
4
  23.5%
6
  37.5%
5
  27.8%
22
  31.9%
30-39
5
  27.8%
11
  64.7%
2
  12.5%
5
  27.8%
23
  33.3%
40-49
2
  11.1%
1
   5.9%
4
  25.0%
6
  33.3%
13
  18.8%
50-59
2
  11.1%
1
   5.9%
3
  18.8%
1
   5.6%
7
  10.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 16 participants 18 participants 69 participants
Female
5
  27.8%
1
   5.9%
3
  18.8%
3
  16.7%
12
  17.4%
Male
13
  72.2%
16
  94.1%
13
  81.3%
15
  83.3%
57
  82.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 16 participants 18 participants 69 participants
Hispanic or Latino
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.4%
Not Hispanic or Latino
18
 100.0%
15
  88.2%
16
 100.0%
18
 100.0%
67
  97.1%
Unknown or Not Reported
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 16 participants 18 participants 69 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
 100.0%
17
 100.0%
16
 100.0%
18
 100.0%
69
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Karnofsky score   [1] 
Median (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 18 participants 17 participants 16 participants 18 participants 69 participants
90
(80 to 100)
90
(80 to 90)
90
(80 to 90)
90
(80 to 90)
90
(80 to 100)
[1]
Measure Description: The karnofsky score was determined according to karnofsky performance scale. The scale ranged from 0 to 100, by 10. A higher value represents a better outcome.
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants 17 participants 16 participants 18 participants 69 participants
18.5
(17.5 to 20.9)
19.4
(17.5 to 20.4)
19.8
(17.7 to 22.7)
18.7
(16.8 to 20.4)
18.9
(17.5 to 20.8)
HIV status  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 18 participants 17 participants 16 participants 18 participants 69 participants
HIV negative 16 16 15 18 65
HIV positive 2 1 1 0 4
1.Primary Outcome
Title Daily Decrease in log10 Transformed Colony-forming Unit (CFU) Counts Per ml Sputum From Baseline (Study Treatment Initiation) to Day 14
Hide Description

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.
Time Frame Pre-entry, Day 0 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with qualified sputum samples who had results available at all time points specified in the time-frame
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 12 11 10 15
Median (Inter-Quartile Range)
Unit of Measure: log10 CFU/ mL
0.134
(0.078 to 0.167)
0.096
(0.028 to 0.211)
0.136
(0.090 to 0.169)
0.119
(0.050 to 0.173)
2.Secondary Outcome
Title Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 14
Hide Description

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.
Time Frame Pre-entry, Day 0 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with qualified sputum samples who had results available at all time points specified in the time-frame
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 16
Median (Inter-Quartile Range)
Unit of Measure: hours
-12
(-17 to -9)
-12
(-16 to -8)
-13
(-17 to -10)
-11
(-14 to -9)
3.Secondary Outcome
Title Daily Change in log10 Transformed Colony-forming Unit (CFU) Counts Per mL Sputum From Baseline (Study Treatment Initiation) to Day 2
Hide Description

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.
Time Frame Pre-entry, Day 0 and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with qualified sputum samples who had results available at all time points specified in the time-frame
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 12 13 12 12
Median (Inter-Quartile Range)
Unit of Measure: log10 CFU/ mL
0.255
(-0.037 to 0.519)
0.385
(-0.050 to 0.475)
0.111
(0.001 to 0.409)
0.034
(-0.366 to 0.443)
4.Secondary Outcome
Title Daily Change in log10 Colony-forming Unit (CFU) Counts Per mL Sputum From Day 2 to Day 14
Hide Description

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.
Time Frame Day 2 and day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with qualified sputum samples who had results available at all time points specified in the time-frame
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 10 11 11 11
Median (Inter-Quartile Range)
Unit of Measure: log10 CFU/ mL
0.143
(0.104 to 0.203)
0.093
(0.010 to 0.171)
0.123
(0.113 to 0.173)
0.104
(0.065 to 0.277)
5.Secondary Outcome
Title Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 2
Hide Description

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.
Time Frame Pre-entry, Day 0 and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with qualified sputum samples who had results available at all time points specified in the time-frame
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 16
Median (Inter-Quartile Range)
Unit of Measure: hours
-31
(-44 to -22)
-30
(-44 to -15)
-29
(-35 to -18)
-25
(-28 to -18)
6.Secondary Outcome
Title Daily Change in Time to Positivity (TTP) From Day 2 to Day 14
Hide Description

The daily change in TTP was calculated as follows:

EBA2-14(TTP) = (TTP at day 2 - TTP at day 14)/12.
Time Frame Day 2 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with qualified sputum samples who had results available at all time points specified in the time-frame
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: hours
-9
(-12 to -6)
-9
(-13 to -6)
-12
(-14 to -8)
-9
(-12 to -7)
7.Secondary Outcome
Title Log10 Transformed Colony-forming Unit (CFU) Count Per mL From Sputum Samples at Baseline and Day 14
Hide Description The log10 CFU count per mL from sputum samples processed by standard method or decontaminated method.
Time Frame Pre-entry, Day 0 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with qualified sputum samples who had results available at least one time point specified in the time-frame
Arm/Group Title Standard Processing Method Decontaminated Processing Method
Hide Arm/Group Description:
The standard sputum processing method
The decontaminated sputum processing method
Overall Number of Participants Analyzed 63 63
Median (Inter-Quartile Range)
Unit of Measure: log10 CFU/ mL
Pre-entry Number Analyzed 54 participants 54 participants
5.80
(5.16 to 6.76)
5.89
(5.10 to 6.62)
Day 0 Number Analyzed 51 participants 56 participants
5.68
(5.16 to 6.65)
5.58
(5.02 to 6.41)
Day 14 Number Analyzed 49 participants 48 participants
4.01
(3.34 to 4.60)
3.74
(3.11 to 4.40)
8.Secondary Outcome
Title Correlation Between Time to Positivity (TTP) and log10 Transformed Colony-forming Unit (CFU) Counts Per mL
Hide Description Pearson correlation coefficient was used to examine the correlation between TTP and log10 CFU among all qualified samples obtained on study
Time Frame Pre-entry, Day 0, Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with qualified sputum samples who had results available at least one time point specified in the time-frame
Arm/Group Title Overall
Hide Arm/Group Description:
Qualified samples from overall participants
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: correlation coefficient
-0.75
9.Secondary Outcome
Title Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-24hour) for Rifampicin (RIF)
Hide Description Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUCs) of Rifampicin from 0 to 24 hours obtained at Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: h*ng/mL
RIF AUC0-24hour at Day 1
37358.8
(23946.7 to 70314.2)
42062.6
(23048.7 to 77672.3)
51434.1
(42018.3 to 69759.7)
39294.0
(21282.6 to 55823.8)
RIF AUC0-24hour at Day 14
31361.4
(15709.9 to 42480.9)
27161.7
(14436.6 to 31522.2)
26751.2
(16603.9 to 32635.8)
30521.0
(20749.5 to 35307.8)
10.Secondary Outcome
Title Rifampicin PK Parameter Clearance (CL/F)
Hide Description Rifampicin PK parameter Clearance (CL/F) obtained Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: L/hour
RIF CL/F Day 1
14.0
(8.3 to 20.1)
12.5
(7.7 to 26.0)
10.5
(7.2 to 14.3)
14.3
(9.2 to 21.1)
RIF CL/F Day 14
18.0
(14.1 to 34.0)
22.1
(14.3 to 31.2)
21.5
(15.7 to 36.1)
17.0
(14.7 to 22.0)
11.Secondary Outcome
Title Rifampicin PK Parameter Maximum Plasma Concentration (Cmax)
Hide Description Rifampicin PK parameter Parameter Maximum Plasma Concentration (Cmax) obtained Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
RIF Cmax at Day 1
5565
(3600 to 7685)
6060
(3200 to 9550)
8660
(4520 to 10800)
4880
(3370 to 7740)
RIF Cmax at Day 14
7145
(3525 to 9055)
6960
(3930 to 9020)
7370
(4700 to 9580)
8350
(5390 to 8970)
12.Secondary Outcome
Title Rifampicin PK Parameter Last Concentration (CLast)
Hide Description 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.
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
RIF CLast at Day 1
74.5
(20.0 to 232.0)
20
(20 to 229)
133
(20 to 288)
20
(20 to 272)
RIF CLast at Day 14
20
(20 to 20)
20
(20 to 20)
20
(20 to 20)
20
(20 to 20)
13.Secondary Outcome
Title AUC0-24hour for Isoniazid (INH) at Day 1
Hide Description PK AUCs of Isoniazid (INH) from 0 to 24 hours obtained at Day 1
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Overall Number of Participants Analyzed 16 15 15
Median (Inter-Quartile Range)
Unit of Measure: h*ng/mL
10725.8
(6412.9 to 16492.5)
7970.6
(4594.4 to 16101.7)
7165.1
(4974.5 to 19045.0)
14.Secondary Outcome
Title Isoniazid PK Parameter CL/F at Day 1
Hide Description Isoniazid PK parameter CL/F obtained Day 1
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Overall Number of Participants Analyzed 16 15 15
Median (Inter-Quartile Range)
Unit of Measure: L/hour
28.0
(18.3 to 49.6)
37.6
(18.6 to 65.3)
41.9
(21.0 to 60.6)
15.Secondary Outcome
Title Isoniazid PK Parameter Cmax at Day 1
Hide Description Isoniazid PK parameter Cmax obtained Day 1
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Overall Number of Participants Analyzed 16 15 15
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
3165
(2315 to 4060)
2920
(1530 to 3610)
2760
(1760 to 4030)
16.Secondary Outcome
Title Isoniazid PK Parameter CLast at Day 1
Hide Description 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.
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Overall Number of Participants Analyzed 16 15 15
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
50
(50 to 50)
50
(50 to 50)
50
(50 to 50)
17.Secondary Outcome
Title AUC0-24hour for Isoniazid at Day 14
Hide Description PK AUCs of Isoniazid from 0 to 24 hours obtained at Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RHZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Overall Number of Participants Analyzed 16
Median (Inter-Quartile Range)
Unit of Measure: h*ng/mL
9797.2
(6931.1 to 16355.9)
18.Secondary Outcome
Title Isoniazid PK Parameter CL/F at Day 14
Hide Description Isoniazid PK parameter CL/F obtained Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RHZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Overall Number of Participants Analyzed 16
Median (Inter-Quartile Range)
Unit of Measure: L/hour
30.6
(18.4 to 46.0)
19.Secondary Outcome
Title Isoniazid PK Parameter Cmax at Day 14
Hide Description Isoniazid PK parameter Cmax obtained Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RHZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Overall Number of Participants Analyzed 16
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
3130
(2485 to 3920)
20.Secondary Outcome
Title Isoniazid PK Parameter CLast at Day 14
Hide Description 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.
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RHZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Overall Number of Participants Analyzed 16
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
50
(50 to 50)
21.Secondary Outcome
Title AUC0-24hour for Pyrazinamide (PZA)
Hide Description PK AUCs of Pyrazinamide (PZA) from 0 to 24 hours obtained at Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: h*ng/mL
PZA AUC0-24hour at Day 1
301214.5
(243041.4 to 344110.0)
255283.0
(204379.9 to 349309.1)
292078.2
(249250.9 to 304794.0)
272853.9
(217158.6 to 314465.1)
PZA AUC0-24hour at Day 14
249879.1
(202652.1 to 319071.7)
201389.7
(174896.2 to 280573.1)
280071.0
(221878.7 to 312248.4)
252276.8
(192061.9 to 307469.4)
22.Secondary Outcome
Title Pyrazinamide PK Parameter CL/F
Hide Description Pyrazinamide PK parameter CL/F obtained Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: L/hour
PZA CL/F Day 1
4.1
(3.3 to 5.0)
4.8
(3.9 to 5.8)
4.7
(3.4 to 5.2)
4.2
(3.7 to 4.9)
PZA CL/F Day 14
4.5
(4.0 to 6.5)
5.4
(4.8 to 6.9)
4.7
(3.9 to 5.3)
4.7
(3.8 to 5.8)
23.Secondary Outcome
Title Pyrazinamide PK Parameter Cmax
Hide Description Pyrazinamide PK parameter Cmax obtained Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
PZA Cmax at Day 1
27650
(24400 to 36550)
27000
(20800 to 29100)
28800
(23900 to 32600)
25800
(24100 to 29000)
PZA Cmax at Day 14
29300
(24950 to 34350)
27000
(22900 to 31000)
29300
(25500 to 33900)
28000
(26300 to 31900)
24.Secondary Outcome
Title Pyrazinamide PK Parameter CLast
Hide Description Pyrazinamide PK parameter CLast obtained Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
PZA CLast at Day 1
3370
(2320 to 5470)
2850
(1500 to 5050)
3130
(2570 to 3460)
2710
(1930 to 3830)
PZA CLast at Day 14
1955.0
(997.5 to 2735.0)
1280
(909 to 3050)
1790
(1450 to 2900)
1770
(1270 to 2150)
25.Secondary Outcome
Title AUC0-24hour for Ethambutol (EMB)
Hide Description PK AUCs of Ethambutol (EMB) from 0 to 24 hours obtained at Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: h*ng/mL
EMB AUC0-24hour at Day 1
11918.8
(9783.4 to 12803.2)
11145.8
(9336.6 to 14125.3)
11322.4
(9549.6 to 13937.0)
10716.8
(9381.2 to 13678.0)
EMB AUC0-24hour at Day 14
16414.9
(13813.1 to 19637.1)
16675.9
(12589.8 to 18585.1)
15181.2
(14074.7 to 17338.1)
16574.6
(13314.9 to 17422.2)
26.Secondary Outcome
Title Ethambutol PK Parameter CL/F
Hide Description Ethambutol PK parameter CL/F obtained Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: L/hour
EMB CL/F Day 1
93.6
(68.7 to 105.0)
85.4
(73.9 to 97.1)
83.8
(65.4 to 106.0)
76.5
(73.9 to 89.8)
EMB CL/F Day 14
57.9
(51.0 to 65.9)
63.5
(53.5 to 72.0)
56.8
(47.1 to 75.2)
60.1
(52.4 to 64.4)
27.Secondary Outcome
Title Ethambutol PK Parameter Cmax
Hide Description Ethambutol PK parameter Cmax obtained Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
EMB Cmax at Day 1
2650
(1745 to 2960)
2040
(1840 to 2460)
2470
(1790 to 3460)
2220
(1900 to 2680)
EMB Cmax at Day 14
2980
(2220 to 3525)
3090
(2270 to 3370)
2780
(2580 to 3220)
2920
(2530 to 3250)
28.Secondary Outcome
Title Ethambutol PK Parameter CLast
Hide Description Ethambutol PK parameter CLast obtained Day 1 and Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
63 with qualified samples were included in the primary and secondary analyses including PK analysis.
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description:
Participants were administered RHZE from Day 1 to Day 14.
Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Participants were administered only RZE from Day 1 through Day 14.
Overall Number of Participants Analyzed 16 15 15 17
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
EMB CLast at Day 1
86.5
(40.0 to 106.5)
85
(40 to 107)
40
(40 to 94)
86
(40 to 95)
EMB CLast at Day 14
205.0
(167.0 to 235.5)
176
(159 to 208)
164
(136 to 199)
159
(134 to 204)
29.Secondary Outcome
Title AUC0-24hour for Moxifloxacin (Mox) at Day 14
Hide Description PK AUCs of Moxiflozacin (Mox) from 0 to 24 hours obtained at Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title RHZE-RMZE
Hide Arm/Group Description:
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: h*ng/mL
22498.4
(21012.8 to 23318.5)
30.Secondary Outcome
Title Moxifloxacin PK Parameter CL/F at Day 14
Hide Description Moxifloxacin PK parameter CL/F obtained Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title RHZE-RMZE
Hide Arm/Group Description:
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: L/hour
17.8
(17.2 to 19.0)
31.Secondary Outcome
Title Moxifloxacin PK Parameter Cmax at Day 14
Hide Description Moxifloxacin PK parameter Cmax obtained Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title RHZE-RMZE
Hide Arm/Group Description:
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
3010
(2710 to 3500)
32.Secondary Outcome
Title Moxifloxacin PK Parameter CLast at Day 14
Hide Description Moxifloxacin PK parameter CLast obtained Day 14
Time Frame -0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RHZE-RMZE
Hide Arm/Group Description:
Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
Overall Number of Participants Analyzed 15
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
178
(150 to 217)
Time Frame From treatment dispensation to study discontinuation. The duration of the study was 29 days.
Adverse Event Reporting Description 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.
 
Arm/Group Title RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Hide Arm/Group Description Participants were administered RHZE from Day 1 to Day 14. Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14. Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14. Participants were administered only RZE from Day 1 through Day 14.
All-Cause Mortality
RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   0/17 (0.00%)   0/16 (0.00%)   0/18 (0.00%) 
Hide Serious Adverse Events
RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   1/17 (5.88%)   1/16 (6.25%)   0/18 (0.00%) 
Infections and infestations         
Pneumonia bacterial † 1  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/18 (0.00%) 
Nervous system disorders         
Loss of consciousness † 1  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Haemoptysis † 1  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/18 (0.00%) 
Vascular disorders         
Deep vein thrombosis † 1  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RHZE-RHZE RHZE-RZE RHZE-RMZE RZE-RZE
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/18 (33.33%)   5/17 (29.41%)   3/16 (18.75%)   5/18 (27.78%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia † 1  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/18 (0.00%) 
Cardiac disorders         
Tachycardia † 1  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/18 (0.00%) 
Gastrointestinal disorders         
Constipation † 1  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/18 (0.00%) 
Toothache † 1  1/18 (5.56%)  1/17 (5.88%)  0/16 (0.00%)  0/18 (0.00%) 
General disorders         
Chest pain † 1  2/18 (11.11%)  0/17 (0.00%)  0/16 (0.00%)  0/18 (0.00%) 
Hepatobiliary disorders         
Hepatotoxicity † 1  2/18 (11.11%)  0/17 (0.00%)  0/16 (0.00%)  0/18 (0.00%) 
Investigations         
Alanine aminotransferase increased † 1  2/18 (11.11%)  0/17 (0.00%)  0/16 (0.00%)  1/18 (5.56%) 
Aspartate aminotransferase increased † 1  2/18 (11.11%)  0/17 (0.00%)  0/16 (0.00%)  0/18 (0.00%) 
Haemoglobin decreased † 1  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  1/18 (5.56%) 
Joint stiffness † 1  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/18 (5.56%) 
Pain in extremity † 1  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/18 (5.56%) 
Nervous system disorders         
Headache † 1  2/18 (11.11%)  2/17 (11.76%)  2/16 (12.50%)  0/18 (0.00%) 
Lethargy † 1  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/18 (0.00%) 
Neuropathy peripheral † 1  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  2/18 (11.11%) 
Paraesthesia † 1  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders         
Tachypnoea † 1  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus generalised † 1  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  1/18 (5.56%) 
Rash † 1  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/18 (5.56%) 
Rash erythematous † 1  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/18 (0.00%) 
Rash pruritic † 1  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social & Scientific Systems, Inc.
Phone: (301) 628-3313
EMail: ACTGCT.Gov@s-3.com
Publications:
The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01589497    
Other Study ID Numbers: ACTG A5307
1U01AI068636 ( U.S. NIH Grant/Contract )
First Submitted: April 30, 2012
First Posted: May 2, 2012
Results First Submitted: January 24, 2017
Results First Posted: April 4, 2017
Last Update Posted: April 6, 2018