Trial · NCT02410772
TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
NCT02410772, Phase 3, Completed, Centers for Disease Control and Prevention; results first posted 2021-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens. Trials, record NCT02410772. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02410772
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
- NCT number
- NCT02410772
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,516 participants, actual
- Lead sponsor
- Centers for Disease Control and Prevention
- Conditions
- Tuberculosis
- Interventions
- rifapentine, rifapentine and moxifloxacin, control
- First posted
- 2015-04-08
- Last updated
- 2024-12-04
- Results first posted
- 2021-09-28
- Limitations and caveats
A study limitation is that placebos were not used, and therefore neither participants nor site staff were blinded to treatment assignment. Another limitation is that only 8% of participants were HIV-coinfected, limiting the power to compare regimens in this important population
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) | Twelve months after treatment assignment | To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis A primary outcome status of "favorable", "unfavorable", or "not assessable" was assigned. For detailed definitions of outcomes please refer to: Dorman SE, at al. N Engl J Med. 2021 May 6;384(18):1705-1718. |
| Primary | TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) | Twelve months after treatment assignment | * To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis * To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis A primary outcome status of "favorable", "unfavorable", or "not assessable" was assigned. For detailed definitions of outcomes please refer to: Dorman SE, at al. N Engl J Med. 2021 May 6;384(18):1705-1718. |
| Primary | Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen (Regimen 1 2HRZE/4HR) Compared to Experimental Regimens, Regimen 3 (2HPZM/2HPM) and Regimen 2 (2HPZ/2HP) (Safety Analysis Population) | Four months and up to 14 days after last does of after study treatment (Regimen 2 and 3) or Six months and up to 14 days after last does of after study treatment (Regimen 1) | * To evaluate the Safety of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis * To evaluate the Safety of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis Grade 3 or higher Adverse Events are collected by Clinical sites in systematic way through the laboratory tests and physical exam during regular study follow up visits and also in a non-systematic way when it was self-reported by participants during the study visits. The events are graded by site investigators per Common Terminology Criteria for Adverse Events (CTCAE V4.03 |
| Secondary | Proportion of Participants Who Are Culture Negative at Eight Weeks | eight weeks | Proportion of participants who are culture negative at eight weeks, liquid media |
| Secondary | Time to Stable Sputum Culture Conversion | four or six months | Time to stable sputum culture conversion, liquid media |
| Secondary | Discontinuation of Assigned Treatment for a Reason Other Than Microbiological Ineligibility (Tolerability) | four or six months | Tolerability of the regimen is evaluated using the outcome of discontinuation of assigned treatment for a reason other than microbiological ineligibility. |
| Secondary | Estimated Steady State Efavirenz PK Parameters Including Mid-dosing Interval Concentration | four months | Among participants with HIV infection receiving efavirenz-based antiretroviral therapy, number of participants who maintained plasma efavirenz concentrations ≥1 mg/L during TB treatment. |
| Secondary | TB Disease-free Survival at Eighteen Months After Study Treatment Assignment | Eighteen months after study treatment assignment. | * To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis * To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis |
| Secondary | TB Disease-free Survival at Eighteen Months After Study Treatment Assignment | Eighteen months after treatment assignment | * To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis * To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis |
| Secondary | Speed of Decline of Sputum Viable Bacilli by Automated Liquid MGIT Culture Days to Detection | 12 months | Parameter estimates of the nonlinear mixed effect models describing longitudinal time to positive (TTP) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) | Twelve months after treatment assignment | The population is the Microbiologically eligible population that included the randomized participants excluding the ones with no evidence of cultures positive for M. tuberculosis, or with resistance to one or more of isoniazid, rifampin or fluoroquinolones, or are enrolled in violation of eligibility criteria | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) | Twelve months after treatment assignment | Excluded Microbiologically eligible participants without an assessable outcomes, if they were not already classified as unfavorable and also did not attend 12M visit but were culture negative when last seen, or had treatment changed due to pregnancy, or died during follow-up with cause unrelated to tuberculosis, or received additional treatment for tuberculosis following exogenous reinfection demonstrated by whole genome sequencing, or died from a violent or accidental death during treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen (Regimen 1 2HRZE/4HR) Compared to Experimental Regimens, Regimen 3 (2HPZM/2HPM) and Regimen 2 (2HPZ/2HP) (Safety Analysis Population) | Four months and up to 14 days after last does of after study treatment (Regimen 2 and 3) or Six months and up to 14 days after last does of after study treatment (Regimen 1) | Safety analyses included all randomized participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants Who Are Culture Negative at Eight Weeks | eight weeks | Microbiologically eligible analysis population, evaluable patients (positive or negative culture result) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Stable Sputum Culture Conversion | four or six months | Microbiologically Eligible Analysis Population | weeks | MEDIAN |
| SECONDARY | Discontinuation of Assigned Treatment for a Reason Other Than Microbiological Ineligibility (Tolerability) | four or six months | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Estimated Steady State Efavirenz PK Parameters Including Mid-dosing Interval Concentration | four months | Analysis Population Description: This analysis population includes participants in EFV group 1 who were already on an EFV-containing ART regimen when initiating RPT-based TB treatment (experimental arms only). That is, this analysis was pre-specified to report data by pooling participants from Regimen 2 (2HPZE/2HP) and Regimen 3 (2HPMZ/2HPM) who were on an EFV-containing ART regimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TB Disease-free Survival at Eighteen Months After Study Treatment Assignment | Eighteen months after study treatment assignment. | The population is the Microbiologically eligible population that included the randomized participants excluding the ones with no evidence of cultures positive for M. tuberculosis, or with resistance to one or more of isoniazid, rifampin or fluoroquinolones, or are enrolled in violation of eligibility criteria | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TB Disease-free Survival at Eighteen Months After Study Treatment Assignment | Eighteen months after treatment assignment | Assessable Population: Excluded the Microbiologically eligible pts without an assessable outcomes as if they were not already classified as unfavorable and add did not attend mo12 visit but were culture negative when last seen, or had treatment changed due to pregnancy, or died during follow-up with cause unrelated to tuberculosis, or received additional treatment for tuberculosis following exogenous reinfection demonstrated by WGS, or died from a violent or accidental death during treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Speed of Decline of Sputum Viable Bacilli by Automated Liquid MGIT Culture Days to Detection | 12 months | The population is the Microbiologically eligible population that included the randomized participants excluding the ones with no evidence of cultures positive for M. tuberculosis, or with resistance to one or more of isoniazid, rifampin or fluoroquinolones, or are enrolled in violation of eligibility criteria. | log10 DTP / day | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) | Regimen 1 (2HRZE/4HR) | Favorable Outcome | 656 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) | Regimen 2 (2HPZ/2HP) | Favorable Outcome | 645 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) | Regimen 3 (2HPMZ/2HPM) | Favorable Outcome | 668 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) | Regimen 1 (2HRZE/4HR) | Unfavorable Outcome | 112 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) | Regimen 2 (2HPZ/2HP) | Unfavorable Outcome | 139 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) | Regimen 3 (2HPMZ/2HPM) | Unfavorable Outcome | 123 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) | Regimen 1 (2HRZE/4HR) | Favorable | 656 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) | Regimen 2 (2HPZ/2HP) | Favorable | 645 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) | Regimen 3 (2HPMZ/2HPM) | Favorable | 668 | Participants | |
TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) | Regimen 1 (2HRZE/4HR) | Unfavorable | 70 | Participants |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen 1 (2HRZE/4HR) | 829 | |
| Overall Study | STARTED | Regimen 2 (2HPZ/2HP) | 838 | |
| Overall Study | STARTED | Regimen 3 (2HPMZ/2HPM) | 849 | |
| Overall Study | Microbiologically Eligible Analysis Population | Regimen 1 (2HRZE/4HR) | 768 | |
| Overall Study | Microbiologically Eligible Analysis Population | Regimen 2 (2HPZ/2HP) | 784 | |
| Overall Study | Microbiologically Eligible Analysis Population | Regimen 3 (2HPMZ/2HPM) | 791 | |
| Overall Study | Assessable Population | Regimen 1 (2HRZE/4HR) | 726 | |
| Overall Study | Assessable Population | Regimen 2 (2HPZ/2HP) | 752 | |
| Overall Study | Assessable Population | Regimen 3 (2HPMZ/2HPM) | 756 | |
| Overall Study | COMPLETED | Regimen 1 (2HRZE/4HR) | 726 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events237
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 | Neutropenia | Blood and lymphatic system disorders | Regimen 1 (2HRZE/4HR) | 48 | 825 | 51 |
| other | Neutropenia | Blood and lymphatic system disorders | Regimen 2 (2HPZ/2HP) | 34 | 835 | 39 |
| other | Neutropenia | Blood and lymphatic system disorders | Regimen 3 (2HPMZ/2HPM) | 56 | 846 | 57 |
| other | Hepatitis | Hepatobiliary disorders | Regimen 1 (2HRZE/4HR) | 26 | 825 | 31 |
| other | Hepatitis | Hepatobiliary disorders | Regimen 2 (2HPZ/2HP) | 27 | 835 | 31 |
| other | Hepatitis | Hepatobiliary disorders | Regimen 3 (2HPMZ/2HPM) | 38 | 846 | 40 |
| serious | Anemia | Blood and lymphatic system disorders | Regimen 1 (2HRZE/4HR) | 0 | 825 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Regimen 2 (2HPZ/2HP) | 1 | 835 | 1 |
| serious | Anemia | Blood and lymphatic system disorders | Regimen 3 (2HPMZ/2HPM) | 0 | 846 | 0 |
| serious | Leukopenia | Blood and lymphatic system disorders | Regimen 1 (2HRZE/4HR) | 0 | 825 | 0 |
1 to 10 of 237Source ClinicalTrials.gov
See all 237 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen 1 (2HRZE/4HR) | 12 | 825 |
| Total, all-cause mortality | Regimen 2 (2HPZ/2HP) | 11 | 835 |
| Total, all-cause mortality | Regimen 3 (2HPMZ/2HPM) | 13 | 846 |
| Total, other adverse events | Regimen 1 (2HRZE/4HR) | 74 | 825 |
| Total, other adverse events | Regimen 2 (2HPZ/2HP) | 61 | 835 |
| Total, other adverse events | Regimen 3 (2HPMZ/2HPM) | 94 | 846 |
| Total, serious adverse events | Regimen 1 (2HRZE/4HR) | 56 | 825 |
| Total, serious adverse events | Regimen 2 (2HPZ/2HP) | 39 | 835 |
| Total, serious adverse events | Regimen 3 (2HPMZ/2HPM) | 37 | 846 |
Source ClinicalTrials.gov
Papers10
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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