Trial · NCT01404312
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
NCT01404312, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2018-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB). Trials, record NCT01404312. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01404312
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
- NCT number
- NCT01404312
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,000 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Tuberculosis, HIV Infections
- Interventions
- Rifapentine (RPT), Isoniazid (INH), Pyridoxine (Vitamin B6)
- First posted
- 2011-07-28
- Last updated
- 2021-11-04
- Results first posted
- 2018-12-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause | 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) | Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome. |
| Secondary | Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs | 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) | Occurrence of any SAE that meets the ICH definition of an SAE |
| Secondary | Number of Participants With a Targeted Adverse Event | 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) | 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 |
| Secondary | 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 | From entry to end of treatment (up to 8 weeks for Arm A; up to 54 weeks for Arm B) | Ordered categories include: 1. Premature permanent treatment discontinuation 2. Treatment hold for more than 7 consecutive days 3. None of the above |
| Secondary | Cumulative Incidence of Death From Any Cause | 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) | 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. |
| Secondary | Cumulative Incidence of Death Due to a Non-TB Event | 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) | Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks. |
| Secondary | Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis | After TB diagnosis | Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug. |
| Secondary | Efavirenz (EFV) Plasma Concentrations in Arm A | Measured at Weeks 0, 2, 4, and 16 | 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. |
| Secondary | Nevirapine (NVP) Plasma Concentrations in Arm A | Measured at Weeks 0, 2, and 4 | Mean and standard deviation |
| Secondary | EFV Plasma Concentrations in Arm B | Measured at weeks 0, 2 and 4 | 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. Outcome measure was not assessed because no participants enrolled under version 2.0 of the protocol were on Efavirenz at study entry. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause | 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) | All participants who started study treatment. | Events per 100 person-years | NUMBER |
| SECONDARY | Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs | 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) | All participants who started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Targeted Adverse Event | 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) | All participants who started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | From entry to end of treatment (up to 8 weeks for Arm A; up to 54 weeks for Arm B) | All participants who started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Incidence of Death From Any Cause | 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) | All Participants who started study treatment | events per 100 participants | NUMBER |
| SECONDARY | Cumulative Incidence of Death Due to a Non-TB Event | 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) | All participants who started study treatment | events per 100 participants | NUMBER |
| SECONDARY | Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis | After TB diagnosis | Participants with a culture-confirmed TB diagnosis who underwent drug susceptibility testing | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efavirenz (EFV) Plasma Concentrations in Arm A | Measured at Weeks 0, 2, 4, and 16 | 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. | nanograms per mL | MEAN |
| SECONDARY | Nevirapine (NVP) Plasma Concentrations in Arm A | Measured at Weeks 0, 2, and 4 | 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. | nanograms per mL | MEAN |
| SECONDARY | EFV Plasma Concentrations in Arm B | Measured at weeks 0, 2 and 4 | Outcome measure was not assessed because no participants enrolled under version 2.0 of the protocol were on Efavirenz at study entry. |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause | RPT Plus INH Regimen (Arm A) | 0.6506 | 95.1% Confidence Interval 0.4242 to 0.8770 | Events per 100 person-years | |
| Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause | INH Regimen (Arm B) | 0.6736 | 95.1% Confidence Interval 0.4428 to 0.9045 | Events per 100 person-years | |
| Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs | RPT Plus INH Regimen (Arm A) | No SAE occurred | 1405 | Participants | |
| Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs | INH Regimen (Arm B) | No SAE occurred | 1390 | Participants | |
| Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs | RPT Plus INH Regimen (Arm A) | At least one SAE occurred | 83 | Participants | |
| Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs | INH Regimen (Arm B) | At least one SAE occurred | 108 | Participants | |
| Number of Participants With a Targeted Adverse Event | RPT Plus INH Regimen (Arm A) | No Targeted Safety Event | 1445 | Participants | |
| Number of Participants With a Targeted Adverse Event | INH Regimen (Arm B) | No Targeted Safety Event | 1446 | Participants | |
| Number of Participants With a Targeted Adverse Event | RPT Plus INH Regimen (Arm A) | Occurrence of Targeted Safety Event | 43 | Participants | |
| Number of Participants With a Targeted Adverse Event | INH Regimen (Arm B) | Occurrence of Targeted Safety Event | 52 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RPT Plus INH Regimen (Arm A) | 1,496 | |
| Overall Study | STARTED | INH Regimen (Arm B) | 1,504 | |
| Overall Study | COMPLETED | RPT Plus INH Regimen (Arm A) | 1,198 | |
| Overall Study | COMPLETED | INH Regimen (Arm B) | 1,193 | |
| Overall Study | NOT COMPLETED | RPT Plus INH Regimen (Arm A) | 298 | |
| Overall Study | NOT COMPLETED | INH Regimen (Arm B) | 311 |
Source ClinicalTrials.gov
Adverse events202
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | RPT Plus INH Regimen (Arm A) | 81 | 1,496 | |
| other | Abdominal pain | Gastrointestinal disorders | INH Regimen (Arm B) | 83 | 1,504 | |
| other | Diarrhoea | Gastrointestinal disorders | RPT Plus INH Regimen (Arm A) | 101 | 1,496 | |
| other | Diarrhoea | Gastrointestinal disorders | INH Regimen (Arm B) | 108 | 1,504 | |
| other | Pyrexia | General disorders | RPT Plus INH Regimen (Arm A) | 198 | 1,496 | |
| other | Pyrexia | General disorders | INH Regimen (Arm B) | 187 | 1,504 | |
| other | Nasopharyngitis | Infections and infestations | RPT Plus INH Regimen (Arm A) | 93 | 1,496 | |
| other | Nasopharyngitis | Infections and infestations | INH Regimen (Arm B) | 84 | 1,504 | |
| other | Pharyngitis | Infections and infestations | RPT Plus INH Regimen (Arm A) | 89 | 1,496 | |
| other | Pharyngitis | Infections and infestations | INH Regimen (Arm B) | 57 | 1,504 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RPT Plus INH Regimen (Arm A) | 21 | 1,496 |
| Total, all-cause mortality | INH Regimen (Arm B) | 27 | 1,504 |
| Total, other adverse events | RPT Plus INH Regimen (Arm A) | 1,051 | 1,496 |
| Total, other adverse events | INH Regimen (Arm B) | 1,042 | 1,504 |
| Total, serious adverse events | RPT Plus INH Regimen (Arm A) | 40 | 1,496 |
| Total, serious adverse events | INH Regimen (Arm B) | 68 | 1,504 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| RPT Plus INH Regimen (Arm A) vs INH Regimen (Arm B): deaths from any cause | Trial comparisons |
| RPT Plus INH Regimen (Arm A) vs INH Regimen (Arm B): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01404312
GET https://conductscience.org/api/trials/v1/NCT01404312/results?page=2