Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01404312 · ClinicalTrials.gov registry record · Phase 3
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 3,000
- Enrollment target
NCT01404312: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01404312 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 3,000 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (289% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01404312, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,000 participants
- Enrollment target
Study Summary
HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.
Primary Outcome
Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.
Interventions
- DRUG Isoniazid (INH)
- DRUG Rifapentine (RPT)
- DIETARY_SUPPLEMENT Pyridoxine (Vitamin B6)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2012-05-23 |
| Est. Completion | 2017-11-14 |
| Phase | Phase 3 |
What the finished NCT01404312 record still lists
NCT01404312 is an interventional study that assigns participants to a tested intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (289% higher).
The record links to 0 conditions, and to 3 interventions - of which Isoniazid (INH) is the first listed.
NCT01404312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01404312 about?
NCT01404312 is a clinical study titled "Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)". HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versu...
What is the current status of trial NCT01404312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,000 participants. The study started on 2012-05-23. Estimated completion is 2017-11-14.
What interventions are being tested in trial NCT01404312?
The interventions under investigation include: Isoniazid (INH) (DRUG), Rifapentine (RPT) (DRUG), Pyridoxine (Vitamin B6) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01404312?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01404312's enrollment target sits among peer trials
3,000 79th of 2000 higher than 1,921 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00004847 · 3,000 participants · Phase 1
Diagnosis of Pheochromocytoma
- NCT00478712 · 3,000 participants
Hirschsprung Disease Genetic Study
- NCT00579566 · 3,000 participants
Novel Biochemical and Molecular Determinants for Soft Tissue Sarcoma
- NCT00816114 · 3,000 participants
Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI