A Phase 2 interventional study of rifapentine and rifapentine 10 mg/kg in Pulmonary Tuberculosis, sponsored by Centers for Disease Control and Prevention. Completed at 29 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Centers for Disease Control and Prevention · Phase 2, Interventional, and Treatment
This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment.
Participants were randomized to receive either a standard rifampin-based regimen (RHZE) or a rifapentine-substituted regimen (PHZE). An extension study evaluated higher daily doses of rifapentine (10, 15, and 20 mg/kg).
The primary endpoint was sputum culture conversion at 8 weeks. Secondary outcomes included time to culture conversion, safety, and treatment discontinuation.
This Phase 2, prospective, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment.
In the main study, adult participants with suspected pulmonary tuberculosis were randomized to receive either a standard intensive-phase regimen consisting of rifampin, isoniazid, pyrazinamide, and ethambutol (RHZE), or an experimental regimen in which rifapentine (10 mg/kg) was substituted for rifampin (PHZE). Treatment was administered five days per week under direct observation for 8 weeks.
The study extension evaluated higher daily doses of rifapentine (10 mg/kg, 15 mg/kg, and 20 mg/kg) in combination with isoniazid, pyrazinamide, and ethambutol, compared to the standard rifampin-based regimen. In the extension, treatment was administered seven days per week.
The primary efficacy endpoint was the proportion of participants with negative sputum cultures at completion of the intensive phase. Secondary endpoints included time to culture conversion, safety and tolerability, and rates of treatment discontinuation.
Following completion of the intensive phase, participants received standard continuation-phase tuberculosis treatment per guidelines.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's enrollment of 334 is above the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Laboratory parameters done within 14 days prior to, enrollment:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
rifampin, isoniazid, pyrazinamide, ethambutol
Drug: rifapentine
rifapentine 10 mg/kg, isoniazid, pyrazinamide, ethambutol
Drug: rifapentine 10 mg/kg
rifapentine 15 mg/kg, isoniazid, pyrazinamide, ethambutol
Drug: rifapentine 15 mg/kg
rifapentine 20 mg/kg, isoniazid, pyrazinamide, ethambutol
Drug: rifapentine 20 mg/kg
tablet, 10 mg/kg, daily, 8 weeks
Also known as: Rifadin
Drug page: Rifapentine
tablet, 10 mg/kg, daily, 8 weeks
Also known as: Priftin
Drug page: Rifapentine
tablet, 15 mg/kg, daily, 8 weeks
Also known as: Priftin
Drug page: Rifapentine
20 mg/kg, daily, 8 weeks
Also known as: Priftin
Participants With Negative Sputum Culture at 8 Weeks
Proportion of participants with negative Mycobacterium tuberculosis sputum cultures at completion of the 8-week intensive phase of treatment.
Time frame: 8 weeks.
Participants Who Discontinued Treatment During Intensive Phase
Number of participants who permanently discontinued assigned study treatment for any reason during the first 8 weeks.
Time frame: 8 weeks
| Milestone | Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol |
|---|---|---|---|---|
| Started | 85 | 87 | 81 | 81 |
| Completed | 74 | 82 | 76 | 72 |
| Not completed | 11 | 5 | 5 | 9 |
| Withdrew: Reason not reported. | 11 | 5 | 5 | 9 |
Proportion of participants with negative Mycobacterium tuberculosis sputum cultures at completion of the 8-week intensive phase of treatment.
| participants | Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol |
|---|---|---|---|---|
| Participants With Negative Sputum Culture at 8 Weeks | 52 | 62 | 59 | 54 |
Number of participants who permanently discontinued assigned study treatment for any reason during the first 8 weeks.
| participants | Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol |
|---|---|---|---|---|
| Participants Who Discontinued Treatment During Intensive Phase | 11 | 5 | 5 | 9 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | 0/85 (0%) | 0/85 (0%) | 0/85 (0%) |
| lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 0/85 (0%) | 0/85 (0%) | 0/85 (0%) |
| Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 0/81 (0%) | 0/81 (0%) | 0/81 (0%) |
| Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | 0/81 (0%) | 0/81 (0%) | 0/81 (0%) |
All randomized participants in the dose-ranging extension phase (N=334).
| Age, Continuous(years) | Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Total |
|---|---|---|---|---|---|
| Median | 33 (19 to 78) | 29 (19 to 66) | 31 (18 to 69) | 31 (19 to 70) | 31 (18 to 78) |
| Sex/Gender, Customized(participants) | Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Total |
|---|---|---|---|---|---|
| Male | 55 | 63 | 58 | 54 | 230 |
| Female | 30 | 24 | 23 | 27 | 104 |
| Race and Ethnicity Not Collected(Participants) | Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| HIV status(Participants) | Standard Intensive-Phase TB Treatment: Rifampin (10 mg/kg) + Isoniazid + Pyrazinamide + Ethambutol | lRifapentine 10 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 15 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Rifapentine 20 mg/kg TB Treatment (PHZE): Isoniazid + Pyrazinamide + Ethambutol | Total |
|---|---|---|---|---|---|
| HIV positive | 5 | 6 | 4 | 11 | 26 |
| HIV negative | 80 | 81 | 77 | 70 | 308 |
Plan to share: No — Individual participant data will not be made available.
The record gives a start of Dec 2008, a primary completion of Jun 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2026, 13 years 1 month after primary completion.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rifapentine
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