NCT01404312 is a Phase 3 clinical trial of Rifapentine (RPT) in Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT01404312?

NCT01404312 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT01404312?

Interventions in NCT01404312: Rifapentine (RPT), Isoniazid (INH), Pyridoxine (Vitamin B6).

What condition does NCT01404312 study?

NCT01404312 studies Tuberculosis, HIV Infections.

Is NCT01404312 still recruiting?

NCT01404312 is currently completed. Last updated 4 November 2021.

Are results published for NCT01404312?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-11-04 · How we verify

NCT01404312

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 4 November 2021

What this trial tests

Phase 3 trial testing Rifapentine (RPT) in Tuberculosis in 3,000 participants. Completed in 14 November 2017.

Timeline

23 May 2012

Primary endpoint
14 November 2017

14 November 2017

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	3,000
Start date	23 May 2012
Primary completion	14 November 2017
Estimated completion	14 November 2017
Sites	45 locations across Zimbabwe, Haiti, South Africa, Peru, Malawi, Botswana, Thailand, Kenya

Drugs / interventions tested

Rifapentine (RPT) — full drug profile →
Isoniazid (INH) — full drug profile →
Pyridoxine (Vitamin B6)

Conditions studied

Tuberculosis — all drugs for Tuberculosis →
HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

13 and older, any sex, with Tuberculosis or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause Primary · 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.

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	0.6506	0.4242 – 0.8770
INH Regimen (Arm B)	0.6736	0.4428 – 0.9045

Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs Secondary · 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

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	1405
INH Regimen (Arm B)	1390
RPT Plus INH Regimen (Arm A)	83
INH Regimen (Arm B)	108

Number of Participants With a Targeted Adverse Event Secondary · 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

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	1445
INH Regimen (Arm B)	1446
RPT Plus INH Regimen (Arm A)	43
INH Regimen (Arm B)	52

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 Secondary · 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

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	16
INH Regimen (Arm B)	25
RPT Plus INH Regimen (Arm A)	11
INH Regimen (Arm B)	31
RPT Plus INH Regimen (Arm A)	1461
INH Regimen (Arm B)	1442

Cumulative Incidence of Death From Any Cause Secondary · 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.

1 year post-entry

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	0.35
INH Regimen (Arm B)	0.63

2 years post-entry

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	0.49
INH Regimen (Arm B)	1.15

3 years post-entry

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	1.05
INH Regimen (Arm B)	1.62

4 years post-entry

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	2.00
INH Regimen (Arm B)	2.29

Cumulative Incidence of Death Due to a Non-TB Event Secondary · 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.

Cumulative incidence by 1 year post-randomization

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	0.3
INH Regimen (Arm B)	0.5

Cumulative incidence by 2 years post-randomization

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	0.4
INH Regimen (Arm B)	1.0

Cumulative incidence by 3 years post-randomization

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	0.9
INH Regimen (Arm B)	1.5

Cumulative incidence by 4 years post-randomization

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	1.6
INH Regimen (Arm B)	2.0

Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis Secondary · After TB diagnosis

Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug.

Rifampin

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	1
INH Regimen (Arm B)	1
RPT Plus INH Regimen (Arm A)	14
INH Regimen (Arm B)	11

Isoniazid

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	2
INH Regimen (Arm B)	1
RPT Plus INH Regimen (Arm A)	12
INH Regimen (Arm B)	11

Ethambutol

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	0
INH Regimen (Arm B)	1
RPT Plus INH Regimen (Arm A)	7
INH Regimen (Arm B)	7

Pyrazinamide

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	0
INH Regimen (Arm B)	0
RPT Plus INH Regimen (Arm A)	6
INH Regimen (Arm B)	6

Efavirenz (EFV) Plasma Concentrations in Arm A Secondary · 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.

Week 0

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	3787	± 4922

Week 2

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	3870	± 7011

Week 4

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	4082	± 4916

Nevirapine (NVP) Plasma Concentrations in Arm A Secondary · Measured at Weeks 0, 2, and 4

Mean and standard deviation

Week0

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	7573	± 3789

Week 2

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	6234	± 4283

Week 4

Group	Value	95% CI
RPT Plus INH Regimen (Arm A)	5797	± 3963

Adverse events — posted to ClinicalTrials.gov

Time frame: From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RPT Plus INH Regimen (Arm A)

Serious: 40/1496 (3%)

Deaths: 21/1496

INH Regimen (Arm B)

Serious: 68/1504 (5%)

Deaths: 27/1504

Serious adverse events (77 terms)

Reaction	System	RPT Plus INH Regimen (Arm A)	INH Regimen (Arm B)
Hepatic enzyme increased	Investigations	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Seizure	Nervous system disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Death	General disorders	—	—
Drug-induced liver injury	Hepatobiliary disorders	—	—
Hepatotoxicity	Hepatobiliary disorders	—	—
Disseminated tuberculosis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Transaminases increased	Investigations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	—	—
Suicide attempt	Psychiatric disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Bundle branch block right	Cardiac disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Anal fistula	Gastrointestinal disorders	—	—
Ascites	Gastrointestinal disorders	—	—
Haematemesis	Gastrointestinal disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Umbilical hernia, obstructive	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—

Other adverse events (24 terms — click to expand)

Reaction	System	RPT Plus INH Regimen (Arm A)	INH Regimen (Arm B)
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Blood sodium decreased	Investigations	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Pyrexia	General disorders	—	—
Neutrophil count decreased	Investigations	—	—
Headache	Nervous system disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Blood albumin decreased	Investigations	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Haemoglobin decreased	Investigations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Blood sodium increased	Investigations	—	—
Weight decreased	Investigations	—	—
Pregnancy	Pregnancy, puerperium and perinatal conditions	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Hypertension	Vascular disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Blood pressure increased	Investigations	—	—
Tonsillitis	Infections and infestations	—	—

Most-reported serious reactions: Hepatic enzyme increased, Neutropenia, Seizure, Anaemia, Intestinal obstruction, Death, Drug-induced liver injury, Hepatotoxicity.

Data from ClinicalTrials.gov NCT01404312 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis.
Swindells S, Ramchandani R, Gupta A, Benson CA, et al · · 2019 · cited 247× · PMID 30865794 · DOI 10.1056/nejmoa1806808
Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons.
Gupta A, Hughes MD, Garcia-Prats AJ, McIntire K, et al · · 2019 · cited 34× · PMID 31415563 · DOI 10.1371/journal.pmed.1002882
Moving toward Tuberculosis Elimination. Critical Issues for Research in Diagnostics and Therapeutics for Tuberculosis Infection.
Keshavjee S, Amanullah F, Cattamanchi A, Chaisson R, et al · · 2019 · cited 21× · PMID 30335466 · DOI 10.1164/rccm.201806-1053pp
TB and HIV Therapeutics: Pharmacology Research Priorities.
Dooley KE, Kim PS, Williams SD, Hafner R. · · 2012 · cited 14× · PMID 22829999 · DOI 10.1155/2012/874083
Pharmacogenetic interactions of rifapentine plus isoniazid with efavirenz or nevirapine.
Haas DW, Podany AT, Bao Y, Swindells S, et al · · 2021 · cited 12× · PMID 32815870 · DOI 10.1097/fpc.0000000000000417
One size does not fit all: community views on choices for TB treatment and prevention.
Makone A, Angami K, Bhattacharya D, Frick M, et al · · 2023 · cited 9× · PMID 37736579 · DOI 10.5588/pha.23.0034
2019: A Banner Year for Tuberculosis Research.
Eisinger RW, Embry AC, Read SW, Fauci AS. · · 2020 · cited 6× · PMID 32043109 · DOI 10.1093/infdis/jiaa051
Applying a Risk-benefit Analysis to Outcomes in Tuberculosis Clinical Trials.
Miyahara S, Ramchandani R, Kim S, Evans SR, et al · · 2020 · cited 5× · PMID 31414121 · DOI 10.1093/cid/ciz784

Verify or expand the search:

Other trials of Rifapentine (RPT)

Trials testing the same drug.

NCT06917495 — Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis · Phase 2 · not yet recruiting
NCT04272242 — Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals · Phase 2 · terminated
NCT03886701 — Doravirine, Rifapentine and Isoniazid Interaction · Phase 1 · completed
NCT02651259 — Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum Women · Phase 1, PHASE2 · completed

Other recruiting trials for Tuberculosis

Currently open trials in the same condition.

NCT05917210 — Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda · NA · recruiting
NCT07170735 — Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level · recruiting
NCT07484490 — Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis · NA · recruiting
NCT06318416 — Precision Rifampin Trial for Personalized Dosing · Phase 1 · recruiting
NCT07170800 — A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets · Phase 2 · recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01404312 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 4 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01404312.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing