Trial Outcomes & Findings for High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB) (NCT NCT01936831)
NCT ID: NCT01936831
Last Updated: 2023-02-17
Results Overview
Negative daily change in log10 CFU indicate decreases in bacterial burden over the 7 day period. Defined as EBA0-7(CFU) = \[Day 7 log10 CFU per mL - baseline log10 CFU per mL\]/7. The baseline measure is the mean of the pre-entry visit and entry visit sputum colony counts.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
282 participants
Primary outcome timeframe
Measured at baseline and Day 7
Results posted on
2023-02-17
Participant Flow
No drug was administered under Step 1. Data collected in Step 1 determined eligibility to Step 2. Participants in Steps 1 and 2 were enrolled from August 2014 to September 2021 at 2 non-US clinical research sites.
Participant milestones
| Measure |
Group 1: inhA Mutation
Group 1 participants had an M. tuberculosis isolate with an inhA resistance mutation
|
Group 2: Neither inhA Nor katG Mutations
Group 2 participants had drug susceptible TB and harbored neither inhA nor kat G resistance mutations
|
Group 3: katG Mutation
Group 3 participants had an M. tuberculosis isolate with a katG resistance mutation.
|
Group 1: 5mg Cohort
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|---|---|---|
|
Step 1: Group Identification
STARTED
|
110
|
85
|
87
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Group Identification
COMPLETED
|
110
|
85
|
87
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 1: Group Identification
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Step 2: Arm Randomization
STARTED
|
0
|
0
|
0
|
13
|
14
|
16
|
16
|
11
|
10
|
|
Step 2: Arm Randomization
COMPLETED
|
0
|
0
|
0
|
13
|
14
|
15
|
16
|
11
|
10
|
|
Step 2: Arm Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: inhA Mutation
Group 1 participants had an M. tuberculosis isolate with an inhA resistance mutation
|
Group 2: Neither inhA Nor katG Mutations
Group 2 participants had drug susceptible TB and harbored neither inhA nor kat G resistance mutations
|
Group 3: katG Mutation
Group 3 participants had an M. tuberculosis isolate with a katG resistance mutation.
|
Group 1: 5mg Cohort
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|---|---|---|
|
Step 2: Arm Randomization
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Karnofsky Score was only collected for participants who were randomized to start study treatment.
Baseline characteristics by cohort
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=14 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=16 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=16 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
n=11 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Step 1 Group 1
n=67 Participants
Group 1 participants had an M. tuberculosis isolate with an inhA resistance mutation. This group only includes participants who did not proceed to step 2.
|
Step 1 Group 2
n=69 Participants
Group 2 participants had drug susceptible TB and harbored neither inhA nor kat G resistance mutations. This group only includes participants who did not proceed to step 2.
|
Step 1 Group 3
n=66 Participants
Group 3 participants had an M. tuberculosis isolate with a katG resistance mutation. This group only includes participants who did not proceed to step 2.
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
n=13 Participants
|
32 years
n=14 Participants
|
34 years
n=16 Participants
|
30 years
n=16 Participants
|
36 years
n=11 Participants
|
39 years
n=10 Participants
|
36 years
n=67 Participants
|
32 years
n=69 Participants
|
35 years
n=66 Participants
|
35 years
n=282 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=13 Participants
|
3 Participants
n=14 Participants
|
6 Participants
n=16 Participants
|
4 Participants
n=16 Participants
|
3 Participants
n=11 Participants
|
3 Participants
n=10 Participants
|
26 Participants
n=67 Participants
|
27 Participants
n=69 Participants
|
22 Participants
n=66 Participants
|
97 Participants
n=282 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=13 Participants
|
11 Participants
n=14 Participants
|
10 Participants
n=16 Participants
|
12 Participants
n=16 Participants
|
8 Participants
n=11 Participants
|
7 Participants
n=10 Participants
|
41 Participants
n=67 Participants
|
42 Participants
n=69 Participants
|
44 Participants
n=66 Participants
|
185 Participants
n=282 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=66 Participants
|
3 Participants
n=282 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
13 Participants
n=13 Participants
|
14 Participants
n=14 Participants
|
16 Participants
n=16 Participants
|
15 Participants
n=16 Participants
|
10 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
66 Participants
n=67 Participants
|
69 Participants
n=69 Participants
|
66 Participants
n=66 Participants
|
279 Participants
n=282 Participants
|
|
Region of Enrollment
Haiti
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
7 Participants
n=11 Participants
|
5 Participants
n=10 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=69 Participants
|
2 Participants
n=66 Participants
|
14 Participants
n=282 Participants
|
|
Region of Enrollment
South Africa
|
13 Participants
n=13 Participants
|
14 Participants
n=14 Participants
|
16 Participants
n=16 Participants
|
16 Participants
n=16 Participants
|
4 Participants
n=11 Participants
|
5 Participants
n=10 Participants
|
67 Participants
n=67 Participants
|
69 Participants
n=69 Participants
|
64 Participants
n=66 Participants
|
268 Participants
n=282 Participants
|
|
Karnofsky Score
|
90 units on a scale
n=13 Participants • Karnofsky Score was only collected for participants who were randomized to start study treatment.
|
90 units on a scale
n=14 Participants • Karnofsky Score was only collected for participants who were randomized to start study treatment.
|
80 units on a scale
n=16 Participants • Karnofsky Score was only collected for participants who were randomized to start study treatment.
|
90 units on a scale
n=16 Participants • Karnofsky Score was only collected for participants who were randomized to start study treatment.
|
80 units on a scale
n=11 Participants • Karnofsky Score was only collected for participants who were randomized to start study treatment.
|
90 units on a scale
n=10 Participants • Karnofsky Score was only collected for participants who were randomized to start study treatment.
|
—
|
—
|
—
|
90 units on a scale
n=80 Participants • Karnofsky Score was only collected for participants who were randomized to start study treatment.
|
|
BMI
|
18.1 kg/m^2
n=13 Participants • BMI was only collected on participants who were randomized to start study treatment.
|
17.7 kg/m^2
n=14 Participants • BMI was only collected on participants who were randomized to start study treatment.
|
18.5 kg/m^2
n=16 Participants • BMI was only collected on participants who were randomized to start study treatment.
|
18.0 kg/m^2
n=16 Participants • BMI was only collected on participants who were randomized to start study treatment.
|
19.3 kg/m^2
n=11 Participants • BMI was only collected on participants who were randomized to start study treatment.
|
17.6 kg/m^2
n=10 Participants • BMI was only collected on participants who were randomized to start study treatment.
|
—
|
—
|
—
|
18.1 kg/m^2
n=80 Participants • BMI was only collected on participants who were randomized to start study treatment.
|
|
HIV Status
Living without HIV
|
11 Participants
n=13 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
11 Participants
n=14 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
12 Participants
n=16 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
13 Participants
n=16 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
9 Participants
n=11 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
8 Participants
n=10 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
—
|
—
|
—
|
64 Participants
n=80 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
|
HIV Status
Living with HIV
|
2 Participants
n=13 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
3 Participants
n=14 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
4 Participants
n=16 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
3 Participants
n=16 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
2 Participants
n=11 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
2 Participants
n=10 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
—
|
—
|
—
|
16 Participants
n=80 Participants • HIV status was only collected on participants who were randomized to start study treatment.
|
PRIMARY outcome
Timeframe: Measured at baseline and Day 7Population: Participants who took at least one dose of study treatment in Step 2 in Groups 1 and 2. CFU was not collected for Group 3. Participants who had missing Baseline or Day 7 CFU counts were not included.
Negative daily change in log10 CFU indicate decreases in bacterial burden over the 7 day period. Defined as EBA0-7(CFU) = \[Day 7 log10 CFU per mL - baseline log10 CFU per mL\]/7. The baseline measure is the mean of the pre-entry visit and entry visit sputum colony counts.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=12 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=11 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=12 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=11 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
Daily Change in log10 Colony-forming Unit (CFU)
|
-0.06 log10 CFU per mL sputum per day
Standard Deviation 0.14
|
-0.18 log10 CFU per mL sputum per day
Standard Deviation 0.12
|
-0.21 log10 CFU per mL sputum per day
Standard Deviation 0.15
|
-0.15 log10 CFU per mL sputum per day
Standard Deviation 0.11
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at baseline and Day 7Population: Participants who took at least one dose of study treatment in Step 2. Participants who had missing Baseline or Day 7 TTP counts were not included.
The time to positivity (TTP) measures growth of mycobacterium tuberculosis using MGIT assay in hours. Higher values of daily change in TTP indicate greater decrease in bacterial burden over the 7 day period and is therefore better. Daily change is defined as EBA0-7(TTP) = \[Day 7 TTP - Baseline TTP\]/7. Baseline is the mean of the pre-entry visit and entry visit TTPs.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=14 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=14 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=16 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
Daily Change in Time to Positivity (TTP)
|
3 hours per day
Standard Deviation 8
|
8 hours per day
Standard Deviation 6
|
10 hours per day
Standard Deviation 8
|
10 hours per day
Standard Deviation 4
|
2.0 hours per day
Standard Deviation 7.9
|
4.6 hours per day
Standard Deviation 7.9
|
PRIMARY outcome
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.Population: Participants in each treatment dose arm with intensive PK results in Step 2.
AUC 0-24h defines area under the concentration-time curve over the period of 24 hours post-dose, estimated through non-compartmental methods using the linear trapezoidal rule.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=14 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=15 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=16 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
n=11 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
INH PK Parameter Area Under the Concentration Time Curve (AUC 0-24 Hours)
|
14.05 ug*hr/mL
Interval 9.27 to 28.73
|
53.08 ug*hr/mL
Interval 23.65 to 67.26
|
50.24 ug*hr/mL
Interval 42.24 to 89.71
|
10.47 ug*hr/mL
Interval 8.04 to 18.09
|
54.13 ug*hr/mL
Interval 37.86 to 92.57
|
70.54 ug*hr/mL
Interval 66.39 to 89.64
|
PRIMARY outcome
Timeframe: Measured from entry through Day 21Population: Participants who took at least one dose of study treatment in Step 2.
Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥Grade 2 that were assessed by the site as drug related. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=14 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=16 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=16 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
n=11 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 2 or Higher Drug-related Adverse Clinical or Laboratory Events
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.Population: Participants in each treatment dose arm with intensive PK results in Step 2.
Cmin defines minimum concentration observed over the 24 hours of the INH dosing interval.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=14 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=15 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=16 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
n=11 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
INH PK Parameter Minimum Plasma Concentration (Cmin)
|
0.053 ug/mL
Interval 0.053 to 0.053
|
0.053 ug/mL
Interval 0.053 to 0.179
|
0.053 ug/mL
Interval 0.053 to 0.099
|
0.053 ug/mL
Interval 0.053 to 0.053
|
0.053 ug/mL
Interval 0.053 to 0.329
|
0.053 ug/mL
Interval 0.053 to 0.221
|
SECONDARY outcome
Timeframe: Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.Population: Participants in each treatment dose arm with intensive PK results in Step 2.
Cmax defines maximum concentration observed over the 24 hours of the INH dosing interval.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=14 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=15 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=16 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
n=11 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
INH PK Parameter Maximum Plasma Concentration (Cmax)
|
5.26 ug/mL
Interval 4.41 to 7.13
|
10.4 ug/mL
Interval 8.26 to 11.9
|
15.1 ug/mL
Interval 12.3 to 17.9
|
4.55 ug/mL
Interval 3.62 to 6.0
|
15 ug/mL
Interval 13.05 to 20.1
|
22.15 ug/mL
Interval 18.1 to 23.75
|
SECONDARY outcome
Timeframe: Day 0Population: Step 1 participants in Group 3 for whom MIC results were available and tested using Thermofisher Sensititre MYCOTB plates. MIC was not done using Thermofisher Sensititre MYCOTB plates for participants enrolled under versions 1.0 and 2.0 of the protocol (including all Group 1 and 2 participants and many Group 3 participants). Three Group 3 Version 3 participants had missing MIC results. Note: Participants were not yet randomized to a treatment in Step 1 so all Group 3 participants are combined.
MIC are determined by phenotypic drug susceptibility testing (DST) based on spot sputum collected at Step 1 Day 0. For group 3 participants shown, MIC was tested using Thermofisher Sensititre MYCOTB plates.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=18 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
1 μg/mL
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
0.03 μg/mL
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
0.06 μg/mL
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
0.12 μg/mL
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
0.25 μg/mL
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
0.5 μg/mL
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
2 μg/mL
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
4 μg/mL
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
|
INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates
>4 μg/mL
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline through day 7Population: Data from all participants were included in the modeling.
Proportions of participants obtained through simulation using the estimated model who have a drop in log10 CFU/mL at or above the threshold of 0.65 log10 CFU/mL; 0.65 is half the drop in log10 CFU/mL observed in participants with DS-TB (Group 2) on day 7. A total of 10000 simulated pseudo-participants per arm were used based on data from the study participants. The NAT2 genotype distribution was based only on Group 1 and 2 participants since NAT2 genotype data was not available for Group 3. The simulations were run repeatedly. The point estimate of the proportion was based on the median proportion of the pseudo-individuals across the repeated simulations and the 90% confidence interval used the 5th and 95th percentiles of the proportion across the repeated simulations.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=14 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=16 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=16 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
n=11 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
Proportions of Participants Estimated to Have a Drop in log10 CFU/mL at or Above 0.65 log10 CFU/mL.
|
0.17 proportion of simulated participants
Interval 0.0 to 0.6
|
0.50 proportion of simulated participants
Interval 0.06 to 0.84
|
0.64 proportion of simulated participants
Interval 0.18 to 0.91
|
0.88 proportion of simulated participants
Interval 0.78 to 0.99
|
0.01 proportion of simulated participants
Interval 0.0 to 0.3
|
0.05 proportion of simulated participants
Interval 0.0 to 0.41
|
SECONDARY outcome
Timeframe: At baseline, day 2, and day 7Population: Four participants were excluded from the analysis due to missing CFU values in Group 1-INH 10 mg (2), Group 1-INH 15mg (1), and Group 2 (1). CFU was not collected for Group 3.
Negative daily change in log10 CFU indicate decreases in bacterial burden over the time period. The mean CFU are estimated using all values by fitting a biphasic regression models for each participant. The daily change for the first two days of treatment was calculated as EBA0-2 (CFU)= \[Day 2 log10 CFU per mL - baseline log10 CFU per mL\]/2. The daily change from day 2 to day 7 was calculated as EBA2-7 (CFU)= \[Day 7 log10 CFU per mL - Day 2 log10 CFU per mL\]/5. Baseline is the average of pre-entry and entry visits.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=12 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=15 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=15 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
Daily Change in log10 CFU Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models
EBA(0-2)
|
-0.23 log10 CFU per mL sputum per day
Standard Deviation 0.30
|
-0.17 log10 CFU per mL sputum per day
Standard Deviation 0.22
|
-0.13 log10 CFU per mL sputum per day
Standard Deviation 0.39
|
-0.41 log10 CFU per mL sputum per day
Standard Deviation 0.33
|
—
|
—
|
|
Daily Change in log10 CFU Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models
EBA(2-7)
|
-0.01 log10 CFU per mL sputum per day
Standard Deviation 0.15
|
-0.17 log10 CFU per mL sputum per day
Standard Deviation 0.13
|
-0.25 log10 CFU per mL sputum per day
Standard Deviation 0.17
|
-0.07 log10 CFU per mL sputum per day
Standard Deviation 0.19
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, day 2, and day 7Population: All available TTP results were used.
The time to positivity (TTP) measures growth of mycobacterium tuberculosis using MGIT assay in hours. Higher values of daily change in TTP indicate greater decrease in bacterial burden over the time period and is therefore better. The mean log transformed TTP are estimated using all values by fitting a biphasic regression models for each participant. The daily change over the first two days of treatment is calculated as EBA0-2 (TTP)= \[Day 2 TTP - baseline TTP\]/2. The daily change from Day 2 to Day 7 is calculated as EBA2-7 (TTP)= \[Day 7 TTP - Day 2 TTP\]/5. Baseline is the average of pre-evaluation and entry visits.
Outcome measures
| Measure |
Group 1: 5mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 10mg Cohort
n=13 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1: 15mg Cohort
n=16 Participants
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2: 5mg Cohort
n=16 Participants
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 15mg Cohort
n=11 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3: 20mg Cohort
n=10 Participants
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
Daily Change in TTP Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models
EBA(0-2)
|
7.78 hours per day
Standard Deviation 17.22
|
11.03 hours per day
Standard Deviation 6.40
|
7.35 hours per day
Standard Deviation 14.73
|
22.39 hours per day
Standard Deviation 11.44
|
2.91 hours per day
Standard Deviation 3.57
|
-1.36 hours per day
Standard Deviation 7.59
|
|
Daily Change in TTP Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models
EBA(2-7)
|
1.77 hours per day
Standard Deviation 9.61
|
5.45 hours per day
Standard Deviation 7.39
|
12.01 hours per day
Standard Deviation 8.29
|
5.09 hours per day
Standard Deviation 6.43
|
2.69 hours per day
Standard Deviation 12.21
|
5.45 hours per day
Standard Deviation 8.36
|
SECONDARY outcome
Timeframe: From baseline through day 7Population: This outcome was not measured.
Both TTPs and log10 CFU from the pre-evaluation and entry visits averaged and treated as the baseline TTP and log10 CFU for each participant. This outcome was included for analysis if the number of phases differed between every dosing cohort. Since the number of phases did not differ between dosing cohorts, this outcome was not measured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline through day 7Population: This outcome was not measured.
This approach utilizes the area between baseline CFU per mL and the CFU curve for each participant, as measured using the trapezoidal rule. This outcome was included for analysis if the number of phases differed between every dosing cohort. Since the number of phases did not differ between dosing cohorts, this outcome was not measured.
Outcome measures
Outcome data not reported
Adverse Events
Group 1- INH 5mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 1- INH 10mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Group 1- INH 15mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 2- INH 5mg
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 3- INH 15mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 3- INH 20mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1- INH 5mg
n=13 participants at risk
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1- INH 10mg
n=14 participants at risk
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1- INH 15mg
n=16 participants at risk
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2- INH 5mg
n=16 participants at risk
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3- INH 15mg
n=11 participants at risk
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3- INH 20mg
n=10 participants at risk
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
7.1%
1/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
Other adverse events
| Measure |
Group 1- INH 5mg
n=13 participants at risk
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 5 mg cohort received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1- INH 10mg
n=14 participants at risk
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 10 mg cohort received Isoniazid 10 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 1- INH 15mg
n=16 participants at risk
Group 1 participants had an M. tuberculosis strain with an inhA mutation only. 15 mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 2- INH 5mg
n=16 participants at risk
Group 2 participants had an M. tuberculosis strain with neither inhA nor katG mutations. All Group 2 participants received Isoniazid 5 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3- INH 15mg
n=11 participants at risk
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 15mg cohort received Isoniazid 15 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
Group 3- INH 20mg
n=10 participants at risk
Group 3 participants had an M. tuberculosis strain with a katG mutation with or without an inhA mutation. 20mg cohort received Isoniazid 20 mg/kg daily plus vitamin B6 \>=25 mg daily for 7 days
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
7.1%
1/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
9.1%
1/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
7.1%
1/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
General disorders
Chest pain
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
7.1%
1/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
General disorders
Facial pain
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
General disorders
Fatigue
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
General disorders
Peripheral swelling
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
7.1%
1/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
14.3%
2/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
7.1%
1/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Infections and infestations
Tuberculous pleurisy
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
21.4%
3/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
31.2%
5/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
12.5%
2/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
35.7%
5/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
25.0%
4/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
25.0%
4/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
10.0%
1/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Blood albumin
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
10.0%
1/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Blood albumin decreased
|
84.6%
11/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
100.0%
14/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
93.8%
15/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
100.0%
16/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
100.0%
11/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
100.0%
10/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
21.4%
3/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
25.0%
4/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
30.0%
3/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
9.1%
1/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Blood potassium increased
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Haemoglobin decreased
|
30.8%
4/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
42.9%
6/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
31.2%
5/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
25.0%
4/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
54.5%
6/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
40.0%
4/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
9.1%
1/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
9.1%
1/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
14.3%
2/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
6.2%
1/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
7.1%
1/14 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/16 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/11 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
0.00%
0/10 • Measured from baseline through Day 21
For participants who took at least one dose of study treatment in Step 2, all new diagnoses (per ACTG criteria for clinical events and other diseases), signs/symptoms (S/S) of grade 2 or higher or any S/S that led to a change in treatment regardless of grade, and all laboratory events regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. Adverse events were only collected on participants who started study treatment. No treatment was administered in Step 1.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place