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Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

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ClinicalTrials.gov Identifier: NCT01404312
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Tuberculosis
HIV Infections
Interventions Drug: Rifapentine (RPT)
Drug: Isoniazid (INH)
Dietary Supplement: Pyridoxine (Vitamin B6)
Enrollment 3000
Recruitment Details Forty-five Clinical Research sites across 10 countries participated in the study. The first participant was randomized on May 23, 2012. Accrual closed on November 12, 2014 with 3,000 participants enrolled in the study.
Pre-assignment Details Randomization was 1:1, and stratified by CD4 count (< 100, 100-250, and > 250 cells/mm^3), and antiretroviral therapy status (receiving antiretroviral therapy or not receiving antiretroviral therapy at enrollment).
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Period Title: Overall Study
Started 1496 1504
Completed 1198 1193
Not Completed 298 311
Reason Not Completed
Death             21             27
Withdrawal by Subject             15             18
Participant Unable to get to clinic             93             103
Lost to Follow-up             115             111
Site closed             22             21
Participant not willing to adhere to req             31             29
Severe debilitation, unable to continue             1             2
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B) Total
Hide Arm/Group Description

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Total of all reporting groups
Overall Number of Baseline Participants 1496 1504 3000
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1496 participants 1504 participants 3000 participants
35.7  (10.3) 35.6  (10.3) 35.7  (10.3)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age at Entry Number Analyzed 1496 participants 1504 participants 3000 participants
<=20 years
77
   5.1%
70
   4.7%
147
   4.9%
>20, <=30 years
421
  28.1%
455
  30.3%
876
  29.2%
>30, <=40 years
523
  35.0%
514
  34.2%
1037
  34.6%
>40, <=50 years
342
  22.9%
331
  22.0%
673
  22.4%
>50 years
133
   8.9%
134
   8.9%
267
   8.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1496 participants 1504 participants 3000 participants
Female
802
  53.6%
812
  54.0%
1614
  53.8%
Male
694
  46.4%
692
  46.0%
1386
  46.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 1496 participants 1504 participants 3000 participants
White Non-Hispanic
16
   1.1%
12
   0.8%
28
   0.9%
Black Non-Hispanic
992
  66.3%
991
  65.9%
1983
  66.1%
Hispanic (Regardless of Race)
361
  24.1%
369
  24.5%
730
  24.3%
Asian, Pacific Islander
122
   8.2%
128
   8.5%
250
   8.3%
Not Reported
5
   0.3%
4
   0.3%
9
   0.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Haiti Number Analyzed 1496 participants 1504 participants 3000 participants
198 198 396
United States Number Analyzed 1496 participants 1504 participants 3000 participants
45 46 91
Malawi Number Analyzed 1496 participants 1504 participants 3000 participants
106 108 214
Botswana Number Analyzed 1496 participants 1504 participants 3000 participants
210 212 422
Brazil Number Analyzed 1496 participants 1504 participants 3000 participants
102 98 200
South Africa Number Analyzed 1496 participants 1504 participants 3000 participants
307 309 616
Zimbabwe Number Analyzed 1496 participants 1504 participants 3000 participants
56 58 114
Kenya Number Analyzed 1496 participants 1504 participants 3000 participants
93 94 187
Thailand Number Analyzed 1496 participants 1504 participants 3000 participants
121 124 245
Peru Number Analyzed 1496 participants 1504 participants 3000 participants
258 257 515
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 1496 participants 1504 participants 3000 participants
24.6  (5.2) 24.5  (5.3) 24.5  (5.2)
IV Drug Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1496 participants 1504 participants 3000 participants
Never
1489
  99.5%
1497
  99.5%
2986
  99.5%
Currently
2
   0.1%
1
   0.1%
3
   0.1%
Previously
5
   0.3%
6
   0.4%
11
   0.4%
Prior Tuberculosis History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1496 participants 1504 participants 3000 participants
Yes
82
   5.5%
89
   5.9%
171
   5.7%
No
1414
  94.5%
1415
  94.1%
2829
  94.3%
Screening CD4 counts  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1496 participants 1504 participants 3000 participants
<100 cells/mm^3
37
   2.5%
37
   2.5%
74
   2.5%
>=100,<=250 cells/mm^3
160
  10.7%
165
  11.0%
325
  10.8%
>250 cells/mm^3
1299
  86.8%
1302
  86.6%
2601
  86.7%
Antiretroviral Therapy (ART) at Entry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1496 participants 1504 participants 3000 participants
Efavirenz-based
650
  43.4%
649
  43.2%
1299
  43.3%
Nevirapine-based
97
   6.5%
100
   6.6%
197
   6.6%
Neither Efavirenz nor Nevirapine-based
3
   0.2%
6
   0.4%
9
   0.3%
Not on ART
746
  49.9%
749
  49.8%
1495
  49.8%
HIV-1 RNA Viral load among participants on ART at entry   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 750 participants 755 participants 1505 participants
Detectable
154
  20.5%
143
  18.9%
297
  19.7%
Undetectable
569
  75.9%
586
  77.6%
1155
  76.7%
Not Reported
27
   3.6%
26
   3.4%
53
   3.5%
[1]
Measure Description: Undetectable defined as HIV-1 RNA < 40 copies/mL
[2]
Measure Analysis Population Description: Measured only in those participants who were taking antiretroviral therapy at entry.
1.Primary Outcome
Title Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause
Hide Description Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.
Time Frame From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment.
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Overall Number of Participants Analyzed 1488 1498
Measure Type: Number
Number (95.1% Confidence Interval)
Unit of Measure: Events per 100 person-years
0.6506
(0.4242 to 0.8770)
0.6736
(0.4428 to 0.9045)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RPT Plus INH Regimen (Arm A), INH Regimen (Arm B)
Comments Mantel-Haenszel method used for estimating standardized incidence rate in each arm and incidence rate difference.
Type of Statistical Test Non-Inferiority
Comments

Non-inferiority margin: 1.25 events per 100 person-years.

Sample size determination was based on the assumption of a primary endpoint rate of 2.0/100 person-years, with a one-sided 0.025 alpha level, and targeting at least 90% power. This required a sample size of approximately 2500. The sample size was adjusted upwards to account for loss to follow-up, interim monitoring, and to allow for subgroup analyses with reasonable power.

Method of Estimation Estimation Parameter Incidence Rate Difference
Estimated Value -0.0231
Confidence Interval (2-Sided) 95.1%
-0.346 to 0.300
Estimation Comments

Estimate given as Incidence rate in Arm A - Incidence Rate in Arm B (negative favors Arm A).

Incidence rate units: Events per 100 person-years

2.Secondary Outcome
Title Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs
Hide Description Occurrence of any SAE that meets the ICH definition of an SAE
Time Frame From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Overall Number of Participants Analyzed 1488 1498
Measure Type: Count of Participants
Unit of Measure: Participants
No SAE occurred
1405
  94.4%
1390
  92.8%
At least one SAE occurred
83
   5.6%
108
   7.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RPT Plus INH Regimen (Arm A), INH Regimen (Arm B)
Comments

Comparison of the proportion of participants with any SAE occurrence between arms A and B.

H0: Proportion of participants with SAE in Arm A = Proportion of participants with SAE in Arm B.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments Not adjusted for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.016
Confidence Interval (2-Sided) 95%
-0.035 to 0.002
Estimation Comments Estimate given as: Proportion Arm A - Proportion Arm B
3.Secondary Outcome
Title Number of Participants With a Targeted Adverse Event
Hide Description Targeted adverse events include each new grade 3 or 4 laboratory value or sign or symptom that is at least one grade increase from baseline for the following: nausea and vomiting; cutaneous; drug-associated fever; elevated aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]), or bilirubin; and peripheral neuropathy
Time Frame From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Overall Number of Participants Analyzed 1488 1498
Measure Type: Count of Participants
Unit of Measure: Participants
No Targeted Safety Event
1445
  97.1%
1446
  96.5%
Occurrence of Targeted Safety Event
43
   2.9%
52
   3.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RPT Plus INH Regimen (Arm A), INH Regimen (Arm B)
Comments

Comparison of the proportion of participants with any targeted adverse event occurrence between arms A and B.

H0: Proportion of participants with a targeted adverse event in Arm A = Proportion of participants with a targeted adverse event in Arm B.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.405
Comments Not adjusted for multiple comparisons
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -.0058
Confidence Interval (2-Sided) 95%
-0.019 to 0.007
Estimation Comments Estimate given as: Proportion Arm A - Proportion Arm B
4.Secondary Outcome
Title Number of Participants in Each Category of Ordered Categorical Variable Indicating Most Stringent Level of Study Drug Management Due to Toxicity That Was Required Over the Treatment Period
Hide Description

Ordered categories include:

  1. Premature permanent treatment discontinuation
  2. Treatment hold for more than 7 consecutive days
  3. None of the above
Time Frame From entry to end of treatment (up to 8 weeks for Arm A; up to 54 weeks for Arm B)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Overall Number of Participants Analyzed 1488 1498
Measure Type: Count of Participants
Unit of Measure: Participants
Premature permanent treatment discontinuation
16
   1.1%
25
   1.7%
Treatment held for more than 7 days
11
   0.7%
31
   2.1%
None of the above
1461
  98.2%
1442
  96.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RPT Plus INH Regimen (Arm A), INH Regimen (Arm B)
Comments

Odds ratio of being in higher category estimated from proportional odds model

H0: Odds ratio of being in higher category for Arm A vs Arm B = 1

Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.093
Confidence Interval (2-Sided) 95%
1.315 to 3.332
Estimation Comments

Estimate given as: Odds of being in higher category (more stringent management due to toxicity) for Arm B compared with arm A

Not adjusted for multiple comparisons.

5.Secondary Outcome
Title Cumulative Incidence of Death From Any Cause
Hide Description Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry.
Time Frame From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants who started study treatment
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Overall Number of Participants Analyzed 1488 1498
Measure Type: Number
Unit of Measure: events per 100 participants
1 year post-entry 0.35 0.63
2 years post-entry 0.49 1.15
3 years post-entry 1.05 1.62
4 years post-entry 2.00 2.29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RPT Plus INH Regimen (Arm A), INH Regimen (Arm B)
Comments H0: Survival curve Arm A = Survival curve Arm B
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3078
Comments Not adjusted for multiple comparisons
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Cumulative Incidence of Death Due to a Non-TB Event
Hide Description Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks.
Time Frame From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who started study treatment
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Overall Number of Participants Analyzed 1488 1498
Measure Type: Number
Unit of Measure: events per 100 participants
Cumulative incidence by 1 year post-randomization 0.3 0.5
Cumulative incidence by 2 years post-randomization 0.4 1.0
Cumulative incidence by 3 years post-randomization 0.9 1.5
Cumulative incidence by 4 years post-randomization 1.6 2.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RPT Plus INH Regimen (Arm A), INH Regimen (Arm B)
Comments

Competing risk analysis using the Fine-Gray model, treating TB-related deaths as competing risks, and other deaths including deaths of unknown cause as the event of interest.

H0: Hazard Ratio for Arm A vs Arm B = 1

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2802
Comments Not adjusted for multiple comparisons
Method Hazard Ratio
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.396
Confidence Interval (2-Sided) 95%
0.762 to 2.559
Estimation Comments Hazard ratio given as: Arm B hazard / Arm A hazard, i.e. HR > 1 favors arm A
7.Secondary Outcome
Title Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Hide Description Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug.
Time Frame After TB diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a culture-confirmed TB diagnosis who underwent drug susceptibility testing
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

Overall Number of Participants Analyzed 15 12
Measure Type: Count of Participants
Unit of Measure: Participants
Rifampin Number Analyzed 15 participants 12 participants
Developed Resistance
1
   6.7%
1
   8.3%
Did not Develop Resistance
14
  93.3%
11
  91.7%
Isoniazid Number Analyzed 14 participants 12 participants
Developed Resistance
2
  14.3%
1
   8.3%
Did not Develop Resistance
12
  85.7%
11
  91.7%
Ethambutol Number Analyzed 7 participants 8 participants
Developed Resistance
0
   0.0%
1
  12.5%
Did not Develop Resistance
7
 100.0%
7
  87.5%
Pyrazinamide Number Analyzed 6 participants 6 participants
Developed Resistance
0
   0.0%
0
   0.0%
Did not Develop Resistance
6
 100.0%
6
 100.0%
8.Secondary Outcome
Title Efavirenz (EFV) Plasma Concentrations in Arm A
Hide Description

Mean and standard deviation.

Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019.

Time Frame Measured at Weeks 0, 2, 4, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Only measured in the first 90 participants randomized to Arm A who entered the study taking EFV and who meet dose timing criteria; and, under Version 2.0 of the protocol, at Weeks 0, 2, 4, and 16 in the first 30 participants randomized to Arm A who enter the study taking EFV and who meet dose timing criteria.
Arm/Group Title RPT Plus INH Regimen (Arm A)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: nanograms per mL
Week 0 Number Analyzed 99 participants
3787  (4922)
Week 2 Number Analyzed 110 participants
3870  (7011)
Week 4 Number Analyzed 87 participants
4082  (4916)
Week 16 Number Analyzed 0 participants
9.Secondary Outcome
Title Nevirapine (NVP) Plasma Concentrations in Arm A
Hide Description Mean and standard deviation
Time Frame Measured at Weeks 0, 2, and 4
Hide Outcome Measure Data
Hide Analysis Population Description
Only measured in the first 90 participants randomized to Arm A who enter the study taking NVP and who meet dose timing criteria. For weeks 0, 2, 4, some samples were missing or contaminated.
Arm/Group Title RPT Plus INH Regimen (Arm A)
Hide Arm/Group Description:

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg will receive 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily.

Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: nanograms per mL
Week0 Number Analyzed 88 participants
7573  (3789)
Week 2 Number Analyzed 88 participants
6234  (4283)
Week 4 Number Analyzed 90 participants
5797  (3963)
10.Secondary Outcome
Title EFV Plasma Concentrations in Arm B
Hide Description

For Version 2.0 of the protocol only, measured in the first 90 participants randomized to Arm B who enter the study taking EFV and who meet dose timing criteria.

Samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program.

Time Frame Measured at weeks 0, 2 and 4
Outcome Measure Data Not Reported
Time Frame From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Adverse Event Reporting Description

At entry, all diagnoses, signs/symptoms, and laboratory values of all grades that occurred 30 days before entry were collected; post-entry, all diagnoses regardless of grade, signs/symptoms of grade 3 or higher, laboratory values grade 3 or higher, and all events that led to a change in treatment were collected.

The DAIDS AE Grading Table (V1.0) and Expedited AE Manual (V2.0) were used.

 
Arm/Group Title RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Hide Arm/Group Description

Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.

Rifapentine (RPT): RPT dosing was based on participants' weight:

Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).

Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).

Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets).

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily

INH Regimen (Arm B) Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.

Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.

Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.

Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH.

All-Cause Mortality
RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   21/1496 (1.40%)   27/1504 (1.80%) 
Show Serious Adverse Events Hide Serious Adverse Events
RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   40/1496 (2.67%)   68/1504 (4.52%) 
Blood and lymphatic system disorders     
Anaemia  1  2/1496 (0.13%)  3/1504 (0.20%) 
Neutropenia  1  5/1496 (0.33%)  0/1504 (0.00%) 
Thrombocytopenia  1  0/1496 (0.00%)  1/1504 (0.07%) 
Cardiac disorders     
Bundle branch block right  1  0/1496 (0.00%)  1/1504 (0.07%) 
Gastrointestinal disorders     
Abdominal pain  1  0/1496 (0.00%)  1/1504 (0.07%) 
Anal fistula  1  0/1496 (0.00%)  1/1504 (0.07%) 
Ascites  1  0/1496 (0.00%)  1/1504 (0.07%) 
Haematemesis  1  0/1496 (0.00%)  1/1504 (0.07%) 
Inguinal hernia  1  0/1496 (0.00%)  1/1504 (0.07%) 
Intestinal obstruction  1  0/1496 (0.00%)  2/1504 (0.13%) 
Umbilical hernia, obstructive  1  0/1496 (0.00%)  1/1504 (0.07%) 
Vomiting  1  1/1496 (0.07%)  1/1504 (0.07%) 
General disorders     
Death  1  1/1496 (0.07%)  2/1504 (0.13%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/1496 (0.00%)  1/1504 (0.07%) 
Drug-induced liver injury  1  1/1496 (0.07%)  2/1504 (0.13%) 
Hepatitis  1  1/1496 (0.07%)  0/1504 (0.00%) 
Hepatitis acute  1  0/1496 (0.00%)  1/1504 (0.07%) 
Hepatotoxicity  1  2/1496 (0.13%)  0/1504 (0.00%) 
Hypertransaminasaemia  1  0/1496 (0.00%)  1/1504 (0.07%) 
Infections and infestations     
Abscess jaw  1  0/1496 (0.00%)  1/1504 (0.07%) 
Acute hepatitis B  1  1/1496 (0.07%)  0/1504 (0.00%) 
Bacterial sepsis  1  1/1496 (0.07%)  0/1504 (0.00%) 
Bone tuberculosis  1  0/1496 (0.00%)  1/1504 (0.07%) 
Breast abscess  1  0/1496 (0.00%)  1/1504 (0.07%) 
Cellulitis  1  0/1496 (0.00%)  1/1504 (0.07%) 
Dengue haemorrhagic fever  1  0/1496 (0.00%)  1/1504 (0.07%) 
Disseminated tuberculosis  1  0/1496 (0.00%)  2/1504 (0.13%) 
Encephalitis  1  0/1496 (0.00%)  1/1504 (0.07%) 
Gastroenteritis  1  1/1496 (0.07%)  1/1504 (0.07%) 
HIV infection  1  0/1496 (0.00%)  1/1504 (0.07%) 
Orchitis  1  1/1496 (0.07%)  0/1504 (0.00%) 
Pneumocystis jirovecii pneumonia  1  0/1496 (0.00%)  1/1504 (0.07%) 
Pneumonia  1  1/1496 (0.07%)  2/1504 (0.13%) 
Retroviral infection  1  0/1496 (0.00%)  1/1504 (0.07%) 
Septic shock  1  1/1496 (0.07%)  0/1504 (0.00%) 
Typhus  1  0/1496 (0.00%)  1/1504 (0.07%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/1496 (0.07%)  0/1504 (0.00%) 
Craniocerebral injury  1  0/1496 (0.00%)  1/1504 (0.07%) 
Incisional hernia  1  0/1496 (0.00%)  1/1504 (0.07%) 
Jaw fracture  1  0/1496 (0.00%)  1/1504 (0.07%) 
Rib fracture  1  0/1496 (0.00%)  1/1504 (0.07%) 
Skin laceration  1  0/1496 (0.00%)  1/1504 (0.07%) 
Stab wound  1  1/1496 (0.07%)  0/1504 (0.00%) 
Investigations     
Blood alkaline phosphatase increased  1  0/1496 (0.00%)  1/1504 (0.07%) 
Blood bilirubin increased  1  0/1496 (0.00%)  1/1504 (0.07%) 
Blood creatinine increased  1  1/1496 (0.07%)  0/1504 (0.00%) 
Haemoglobin decreased  1  0/1496 (0.00%)  1/1504 (0.07%) 
Hepatic enzyme increased  1  1/1496 (0.07%)  7/1504 (0.47%) 
Transaminases increased  1  2/1496 (0.13%)  0/1504 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/1496 (0.13%)  0/1504 (0.00%) 
Hypoglycaemia  1  0/1496 (0.00%)  1/1504 (0.07%) 
Musculoskeletal and connective tissue disorders     
Arthritis reactive  1  1/1496 (0.07%)  0/1504 (0.00%) 
Back pain  1  1/1496 (0.07%)  0/1504 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma  1  0/1496 (0.00%)  1/1504 (0.07%) 
Hepatocellular carcinoma  1  2/1496 (0.13%)  0/1504 (0.00%) 
Lymphoma  1  0/1496 (0.00%)  1/1504 (0.07%) 
Nervous system disorders     
Cerebellar ischaemia  1  0/1496 (0.00%)  1/1504 (0.07%) 
Epilepsy  1  0/1496 (0.00%)  1/1504 (0.07%) 
Idiopathic intracranial hypertension  1  0/1496 (0.00%)  1/1504 (0.07%) 
Presyncope  1  0/1496 (0.00%)  1/1504 (0.07%) 
Seizure  1  0/1496 (0.00%)  4/1504 (0.27%) 
Subarachnoid haemorrhage  1  0/1496 (0.00%)  1/1504 (0.07%) 
Superior sagittal sinus thrombosis  1  1/1496 (0.07%)  0/1504 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion incomplete  1  0/1496 (0.00%)  2/1504 (0.13%) 
Abortion spontaneous  1  0/1496 (0.00%)  1/1504 (0.07%) 
Psychiatric disorders     
Bipolar disorder  1  0/1496 (0.00%)  1/1504 (0.07%) 
Suicide attempt  1  2/1496 (0.13%)  1/1504 (0.07%) 
Renal and urinary disorders     
Renal impairment  1  1/1496 (0.07%)  0/1504 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia  1  0/1496 (0.00%)  1/1504 (0.07%) 
Ovarian cyst  1  0/1496 (0.00%)  1/1504 (0.07%) 
Postmenopausal haemorrhage  1  0/1496 (0.00%)  1/1504 (0.07%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/1496 (0.00%)  1/1504 (0.07%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/1496 (0.07%)  1/1504 (0.07%) 
Dermatitis allergic  1  1/1496 (0.07%)  0/1504 (0.00%) 
Diabetic foot  1  1/1496 (0.07%)  0/1504 (0.00%) 
Rash  1  2/1496 (0.13%)  1/1504 (0.07%) 
Vascular disorders     
Hypovolaemic shock  1  0/1496 (0.00%)  1/1504 (0.07%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RPT Plus INH Regimen (Arm A) INH Regimen (Arm B)
Affected / at Risk (%) Affected / at Risk (%)
Total   1051/1496 (70.25%)   1042/1504 (69.28%) 
Gastrointestinal disorders     
Abdominal pain  1  81/1496 (5.41%)  83/1504 (5.52%) 
Diarrhoea  1  101/1496 (6.75%)  108/1504 (7.18%) 
General disorders     
Pyrexia  1  198/1496 (13.24%)  187/1504 (12.43%) 
Infections and infestations     
Nasopharyngitis  1  93/1496 (6.22%)  84/1504 (5.59%) 
Pharyngitis  1  89/1496 (5.95%)  57/1504 (3.79%) 
Tonsillitis  1  79/1496 (5.28%)  65/1504 (4.32%) 
Upper respiratory tract infection  1  118/1496 (7.89%)  117/1504 (7.78%) 
Investigations     
Alanine aminotransferase increased  1  102/1496 (6.82%)  121/1504 (8.05%) 
Aspartate aminotransferase increased  1  94/1496 (6.28%)  118/1504 (7.85%) 
Blood albumin decreased  1  97/1496 (6.48%)  125/1504 (8.31%) 
Blood alkaline phosphatase increased  1  99/1496 (6.62%)  99/1504 (6.58%) 
Blood pressure increased  1  83/1496 (5.55%)  63/1504 (4.19%) 
Blood sodium decreased  1  219/1496 (14.64%)  200/1504 (13.30%) 
Blood sodium increased  1  87/1496 (5.82%)  107/1504 (7.11%) 
Haemoglobin decreased  1  112/1496 (7.49%)  120/1504 (7.98%) 
Neutrophil count decreased  1  189/1496 (12.63%)  146/1504 (9.71%) 
Weight decreased  1  74/1496 (4.95%)  105/1504 (6.98%) 
Nervous system disorders     
Headache  1  155/1496 (10.36%)  149/1504 (9.91%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  93/1496 (6.22%)  102/1504 (6.78%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  254/1496 (16.98%)  238/1504 (15.82%) 
Nasal congestion  1  125/1496 (8.36%)  123/1504 (8.18%) 
Oropharyngeal pain  1  202/1496 (13.50%)  166/1504 (11.04%) 
Rhinorrhoea  1  122/1496 (8.16%)  130/1504 (8.64%) 
Vascular disorders     
Hypertension  1  95/1496 (6.35%)  75/1504 (4.99%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
EMail: ACTGCT.Gov@s-3.com
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01404312     History of Changes
Other Study ID Numbers: A5279
10848 ( Registry Identifier: DAIDS ES Registry Number )
ACTG A5279 ( Other Identifier: Network )
First Submitted: July 26, 2011
First Posted: July 28, 2011
Results First Submitted: November 14, 2018
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018