Trial · NCT02410772
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| OTHER_PRE_SPECIFIED | Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculosis Deaths Have an Unfavorable Outcome | 12 months | Microbiologically eligible analysis population. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculosis Deaths Have a Favorable Outcome | 12 months | Assessable analysis population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02410772/outcomes